Rajiv Gandhi University of Health Sciences, Karnataka



Rajiv Gandhi University of Health Sciences, Karnataka

SYNOPSIS

FOR REGISTRATION OF SUBJECT FOR DISSERTATION

|1. |NAME OF THE CANDIDATE |Mr. BINESH.P.C |

|2. |NAME OF THE INSTITUTION |Diana College of Nursing |

| | |No:68,chokkanahalli.Jakkur post Bangalore-64 |

|3. |COURSE OF STUDY AND SUBJECT |Master Of Science In Nursing |

| | |Medical &Surgical Nursing |

|4. |DATE OF ADMISSION TO COURSE |10.06.2009 |

|5. |TITLE OF THE TOPIC | EFFECTIVENESS OF BLACK TEA ON SELECTED PHYSIOLOGICAL PARAMETER S |

| | |AMONG HYPERCHOLESTEROLEMIC ADULTS IN SELECTED I.T INDUSTRY BANGALORE, |

| | |KARNATAKA. |

6. BRIEF RESUME OF THE INTENDED WORK

INTRODUCTION

We have fats (lipids) in our body that are necessary for life. Vegans who eat no cholesterol whatsoever still produce it in their liver. Total cholesterol (TC) is most important to measure. HDL Takes cholesterol from the blood stream into liver, While LDL takes it back into the blood stream. Therefore we want high HDL and low LDL levels generally. There is a general international consensus that the desirable serum concentration of cholesterol should be < 170 mg/dl (> 4.42 m mol/L) which may also be optional for Indian’s. Values between 170 -200 mg /dl (4.42- 5.2 m mol/L) should be considered border line.1

In the inter heart study, the highest population attributable risk was abnormal lipids in both sexes. The study indicate that abnormalities in lipid metabolism play an important role in development of CAD in young Indians 2

National cholesterol education program has done a lot to tell the public about the dangers of high cholesterol. 361,662 men aged 35-57 were studied for six years. The men with low cholesterol had only 3 deaths per 1000 every year while the men with high cholesterol had 16 deaths per year .over 500% more fatalities.1

High blood cholesterol is estimated to cause about an 4.4 million deaths (7.9%Total) . This accounts to 18 % strokes and 56 % of global CHD3. A blood cholesterol level less than 5.0 millimoles/litter is suggested for both primary and secondary prevention of CHD. About 66% of men and women in the U.K have blood cholesterol levels of 5.0mmol/L and above.4

According to WHO in 2002 there were 7.22 million deaths from CHD Globally5. Every seven minutes a Canadian dies of heart disease and stroke. CVD accounts for more deaths than any other disease. 6

WHO reports says CVD is now more prevalent in India and china, than in all economically developed countries combined. 80%chronic disease deaths occurs in low and middle income countries, and half are women. CVD alone kill five times as many people as HIV /AIDS in these countries7.

In India CAD rates has increased during last 30 years where as declining trends have been noticed in developed western countries . Reports on CAD states that Indians are 3-4 times higher risk than white Americans , six times higher than Chinese 20 times higher than Japanese 2

CAD is more prevalent in people having lack of physical activity .high economic status and western food habits .Most of the IT employs are having sedentary life styles so they are prone to get obesity, hypercholesterolemia and hypertension .

Control of CVD will require modification of risk factors that have two characteristics. First the risk factor must have high attributable risk or high prevalence or both, secondary or all of the risk must be reversible cost effectively. Hypercholesterolemia, blood pressure (hypertension) and obesity, is directly associated with risk of several types of cardio vascular disease. However most of all related risks appear to be reversible within a few years with inexpensive interventions8. There are so many pharmacological and non pharmacological remedies are available to treat hypercholesterolemia, obesity and hypertension.

Tea is the most widely consumed beverages in the world and may be associated with reduced heart disease rates, hypertension and obesity. Theaflavins, which are formed in the production of black tea, have been suggested being responsible for the blood-cholesterol-lowering (BCL) effects of tea. The effect of theaflavins on BCL through interference in the formation of dietary mixed micelles, which result in reduced intestinal cholesterol absorption. Tea extract inhibit fat digesting lipase enzymes of the stomach and pancreas by inhibiting fat digesting enzymes tea likely reduce fat digestion in humans thus averting obesity. Black tea extracts reverse endothelial dysfunction and reduces hypertension by producing flow mediated vasodilatation. 9

Because of all these effects, the investigator aimed to assess the effectiveness tea on reducing blood cholesterol level.

6.1NEED FOR THE STUDY

Hypercholesterolemia is a condition in which there is an abnormal lipid or lipoprotein concentration. Hypercholesterolemia is determined by genetic, demographic and lifestyle factors.10 High levels of plasma total cholesterol (TC)11,12triglycerides (TGS)13, low density lipoprotein cholesterol (LDL-C)14and low levels of high density lipoprotein (HDL-C) are correlated with the progression of atherosclerosis and a higher incidence of coronary artery disease 15.

High blood cholesterol causes more than 4 million premature deaths a year. Compared to 2000,the number of years of productive life lost to CVD will have increased in by 2030 by only 20% in the united states and by 30% brazil the figure is 64% for china and for India 95%16

Asian Indian living both in India and abroad – have one of the highest rates of Coronary Artery diseases (CAD) in the world, three times higher than the rates among Caucasians in the United states. The CAD among Indians in usually more aggressive at the time compared with whites or east stations. The overall impact is much greater because the CAD in Asian Indian affects the younger population. Various factors that are thought to contribute this rising epidemic include urbanization of rural areas sedentary life style abdominal obesity increased use of fried, processed fast food, tobacco abuse, poor awareness and control of CAD risk factors. Unique dislipidemic (high tri glycerides or low HDL cholesterol)17

In India past five decades rates of coronary disease among urban population have risen from 4% to 11%.the WHO estimates that 60%of the worlds cardiac patient will be Indian by 2010.One fifth of deaths in India are from coronary artery heart disease by the year of 2020, it will account for one third of all deaths, sadly many of these Indians will be young current projections suggest that by the year 2020 India will have the largest cardiovascular burden in theworld.18

The risk of cardiovascular disease considerably greater among obese people. The US centres of disease control estimates that over 60 million Americans or 30% of the adult population are obese. In India the proportion of overweight people (including those who are obese will increase from 9% to24% between 1995 and 2025 19

“As our weight increases so do our risk levels”

Obesity related illnesses are going to lead the pack as cause of death in world. Obesity leads to high blood pressure, type II diabetes and increased risk of cancer. Incidence of Hypertension five times more among obese people, compared to normal weight. Hence overweight and obesity are contributing to a global increase in hypertension. One billion people had hypertension in 2000 and 1.56 billion people are expected to have this condition by 2025.20

Researcher’s worldwide considers there is a 20 years window of opportunity to make inroads against the ravage of CVD. To slow the momentum of CVD in countries such as India particularly among the working –age population, major initiatives are needed to compact CVD, whether promotion of diet and physical activity, generation of awareness among both sexes or development of guidelines for risk fasters and therapeutic and surgical strategies.

An cost effective preventive strategy will need to focus on reducing hypercholesterolemia both in the individual and in the population at large however, there are so many methods are there to reduce hypercholesterolemia among that consumption of black tea is proved more effective .

According to recent findings ,theaflavins plant based compounds of the flanranoids family which are found in black tea reduces the risk of cardiovascular disease. Inhibitory effect of black tea theaflavins on the incorporation of cholesterol in to mi-cells 10

Study conducted on pharmacological effect of tea shown antioxidative, anti-inflammatory, anticarcinogenic, antiarteriosclerotic and antibacterial effect. Black tea is a source of caffeine a methylaxathene that stimulate the central nervous system, relaxes smooth muscle in the air ways to the lungs (bronchioles). Stimulate the heart, and acts on the kidney as a diuretic. One cup tea contains about 50 milligrams of caffeine. Tea also contains polyphenols (catechins, anthocyanins, phenolicacid ) tannin ,trace elements and vitamins. The leaves of black tea plants are heat producing herbs. This means that these leaves, when consumed, can raise the body’s metabolism. Clinical studies show that black tea can boost energy levels, increase the metabolism, and thereby promote weight loss.24

Tea has been found to increase in the oxidation of fats. Human studies suggest that tea conception is associated with decrease body mass and fat. 25

A recent study on 55 healthy hyperlipidemic men and women shows a preliminary diet with a high intake of plant steroids about 30% reduction in cholesterol compared to 8% reduction in control group 26

A study was conducted on black tea consumption reduces total and LDL cholesterol in mildly hypercholesterolemia adults. Shows five servings of tea were compared with a placebo beverage in a blinded randomised crossover study (7 men and 8 women) tea reduced total cholesterol to 6.5%, LDL cholesterol to 11.1%, appolipoprotein B.27

Black tea is a glucose regulator that aids in weight loss by slowing the action of a particular digestive enzyme called amylase. This enzyme is crucial in the breakdown and metabolizing of carbohydrates. This means that green tea can slow the rise of blood sugar that occurs after a meal and stabilize lowered blood sugar levels that might otherwise lead to binge eating. Black tea also helps to increase the body’s metabolic rate, causing those who use it to experience greater calorie burn that further contributes to weight loss.Weight gain occurs when there is an excess supply of sugars and fats that are stored in the body as fat cells. The components of tea can help prevent weight gain by inhibiting the movement of glucose in these fat cells.28

A study conducted to find out effects of catechins on body fat reduction and weight loss in a group of 35 Japanese men. mass index, an indicator of body fat) and waist sizes.The men were divided into two groups. For three months, the first group drank a bottle of oolong tea fortified with black tea extract containing 690 milligrams of catechins, and the other group drank a bottle of oolong tea with 22 milligrams of catechins.During .After three months, the study showed that the men who drank the tea extract lost more weight (5.3 pounds vs. 2.9 pounds) and experienced a significantly greater decrease in BMI, waist size, and total body fat29

| |

A cross-sectional survey was conducted on 1210 epidemiologically sampled adults (569 men and 641 women) were enrolled in our study. Percent body fat (BF%) was measured using bioelectrical impedance analysis. Body fat distribution was assessed using waist-to-hip ratio (WHR). Results shows among the 1103 analyzed subjects, 473 adults (42.9%) consumed tea once or more per week for at least 6 months. Habitual tea drinkers for more than 10 years showed a 19.6% reduction in BF% and a 2.1% reduction in WHR compared with non-habitual tea drinkers. In contrast, longer duration of habitual tea consumption and higher total physical activity were negative factors for BF%. Longer duration of habitual tea consumption, higher socioeconomic status, and premenopausal status were negative factors for WHR.30

Recent studies shows that hypercholesterolemia &obesity is more prevalent in higher economic status people, those who are living in urban areas , sedentary life styles ,food habits1.

A study was conducted on methods of establishing surveillance system for CAD in Indian industrial population which demonstrates very high levels of CAD risk factors among a relatively young population from industrial settings across India.32 IT employees usually having sedentary life styles which Makes them more prone to obesity, hypercholesterolemia and related complications31

Thus the major function of a Medical surgical nurse is prevention of occurrence of disease (prevention is better than cure) through improvement in the lifestyle and dietary modifications. Hence the investigator felt there is a need to find effective, non invasive, inexpensive and widely available tool to reduce hypercholesterolemia, obesity and hypertension as it is a major modifiable risk factors for the second most killing disease in the world CAD

6.2 REVIEW OF LITERATURE

A review of literature refers to activities involved in identifying and searching for information on a topic and developing and understanding the state of knowledge on the topic. Researcher never conduct a study in an intellectual vacuum their studies are usually undertaken within the context of an existing basic knowledge

The literature is reviewed and presented under the following headings

Literatures related to alteration in physiological parameters in hypercholesterolemic adults

Literatures related to effect of Black tea

Literatures related to effect of Black tea on physiological parameters of hypercholesterolemic adults

1. Literatures related to alteration in physiological parameters in hypercholesterolemic adults

A study was conducted among an isolated subgroup of the China. To compare the effects of demography, diet and lifestyle on serum lipid levels. A total 1170 subjects aged 15 to 89 years were surveyed by a stratified randomized cluster sampling. Study found Hyper lipidemia was positively co related with BMI waist circumference, total energy intake and total fat intake and negatively associated with physical activity and total dietary intake in both populations. The difference in the lipid profile between the two ethnic group were associated with different dietary habits lifestyle and level of physical activity32

A study was conducted to find the relation between body fat and elevated serum levels of CRP. This study verifies relation between adiposity measures, demographic and biochemical variables with CRP serum levels in a rural population. The study was conducted among individuals aged 18 or more, both sexes and at least two years of residency in the place of study.. Age varied from 18 to 94, age mean was 43.34. Bivariate analysis found significant correlations between lnCRP and the following variables: BMI, waist circumference, WHR, age, education, systolic and diastolic blood pressure, total cholesterol, LDL-c, HDL-c, triglycerides, fasting insulin and HOMA-IR. After adjusting for confounding variables in multiple linear regression analysis only BMI, age, sex, fasting insulin and HDL-c remained significantly associated with lnCRP. The independent association of traditional risk factors for cardiovascular disease (age, sex, BMI, fasting insulin and HDL-c) with PCR evidences a close relationship between adipose tissue, cardiovascular diseases and inflammation.33

A study was conducted in surveillance system for cardiovascular diseases in Indian industrial population.Subjects were employees and their family members and were

selected by age and sex stratified random sampling. Medical colleges close to

these companies served as the study centers. Results shows the prevalence of CVD risk factors is reportedfor19,973 for the questionnaire survey and 10,442 for biochemical investigationswith the mean age of the participants 40 years. The overall prevalence of most both primary and secondary or modifiable risk factors was high in these individuals aged 20-69 years: 50.9% of men and 51.9% of women were

overweight; central obesity was observed among 30.9% of men 32.8% of women; and

40.2% of men and 14.9% of women reported current tobacco use. Self-reported

prevalence of diabetes (5.3%) and hypertension (10.9%) was lower than measured

clinically and biochemical (10.1% and 27.7%). Metabolic syndrome prevalence was

26.6% (20.9% in men and 36.3% in women by modified NCEP ATP III criteria). A

marked heterogeneity in the prevalence of risk factors was observed among the

study centers due to dissimilar levels of urbanization in these industrial

settings (from rural/semi-rural to urbanized regions).31

2. Literatures related to effect of Black tea

A study was conducted to find out relation between tea consumption and serum lipid concentrations was examined using cross-sectional data on 1,306 males who received the retirement health examination at the Self-Defense Forces Fukuoka Hospital between October 1986 and December 1988. Results shows after adjustment for rank, smoking, alcohol use, physical activity, and body mass index, serum total cholesterol levels were found to be inversely related to the consumption of green tea while no association was noted with serum triglycerides and high-density lipoprotein cholesterol. Adjusted mean concentrations of total cholesterol were 8 mg/dl lower in men drinking nine cups or more per day than in those consuming zero to two cups per day. Serum cholesterol levels were inversely associated with traditional Japanese dietary habits (intake of rice and soy bean paste soup) and positively associated with Westernized habits. Additional adjustment for these dietary variables did not alter the inverse relation between green tea and total cholesterol.34

A study was conducted with a major purpose to examine inhibitory effect of the catechin derivatives from Japanese green tea Camellia sinensis on collagenase activity. The crude tea catechins, which contain (+)-catechin (C), (-)-epicatechin (EC), (+)-gallocatechin (GC), (-)-epigallocatechin (EGC), (-)-epicatechin gallate (ECg), and (-)-epigallocatechin gallate (EGCg), were tested for their ability to inhibit the prokaryotic and eukaryotic cell derived collagenase activities. Among the tea catechins tested, ECg and EGCg showed the most potent inhibitory effect on collagens activity when an optimal concentration of tea catechins (100 micrograms/ml) was added to reaction mixture containing collagenase and collagen. Preincubation of collagenase with tea catechins reduced the collagenase activity as well. In contrast to ECg and EGCg, the other four tea catechins (C, EC, EGC, and GC) did not show any collagenase inhibitory effect. Our results suggest that the steric structure of 3-galloyl radical is important for the inhibition of collagenase activity. The collagenase activity in the gingival crevicular fluid from highly progressive adult periodontitis was completely inhibited by the addition of tea catechins. These results demonstrated that tea catechins containing galloyl radical possess the ability to inhibit both eukaryotic and prokaryotic cell derived collagenase.35

A study was conducted on antibacterial effect of black tea .Researchers found that extracts of Japanese tea leaves inhibited the growth of various bacteria causing diarrheal diseases. All tea samples tested showed antibacterial activity against Staphylococcus aureus, S. epidermidis, Vibrio cholerae O1, V. cholerae non O1. V. parahaemolyticus, V. mimicus, Campylobacter jejuni and Plesiomonas shigelloides. None of the tea samples had any effect on the growth of V. fluvialis, Aeromonas sobria, A. hydrophila, Pseudomonas aeruginosa, Salmonella enteritidis, enteroinvasive Escherichia coli, enterohemorrhagic E. coli, enteropathogenic E. coli, enterotoxigenic E. coli, Enterobacter cloacae or Yersinia enterocolitica. Salmonella and Shigella showed susceptibilities different depending on the kind of Japanese tea. Japanese tea showed also bactericidal activity over S. aureus, V. parahaemolyticus and even enteropathogenic E. coli which was not sensitive when tested by cup method. The bactericidal activity was shown even at the drinking concentration in daily life.36

1. Literatures related to effect of Black tea on physiological parameters of hypercholesterolemic adults

A study crossover study was conducted to assess the effect in humans regular ingestion of black tea on homeostasis related variables and cell adhesion molecule .22 subjects were selected .During 4weeks baseline period all subjects drank 5 cups /day of hot water .the effects of 5 cups black tea of four weeks were compared with hot water results shown the 24 hours urinary excretion of 4OMGA(4-O-methylgallic acid) was increased during regular ingestion of black tea in comparison with hot water. Black tea resulted in lower soluble p-selection (p=0.01) the effect of black tea on soluble p-selectin provides a potential mechanism for cardiovascular benefits.37

A study was conducted to find effect of black tea consumption in lowering total & low density lipoprotein in mildly hypercholesterolemic adults .researcher selected 8men &8women 35 years and older with elevated cholesterol and within 90% to 140% of ideal body weight .investigator excluded subjects with major health problems and those who are taking medications that could interfere with lipid metabolism .after three weeks o black tea administration researcher found reduction in total cholesterol by 6.5% LDL by 11.5% .they concluded that the inclusion of tea in the diet has the potential to significantly reduce blood cholesterol and thereby reduce the risk of CAD and shoud be encouraged.27

A study Conducted to find out efficiency and safety of Chinese black tea extract in healthy and hypercholesterolemic subjects. Animals (test 1) and human (test 2-5) were given BTE in the following studies. Test 2 a dose finding 8 week toxicity study with excessive BTE ingestion (0.75 or 1g/day) on healthy and 10 boaderline hypercholesterolemic subjects (test 3) a 1- day acute toxicity test using a (10g) single- bolus study (n=10) (test 4) a 5 week long term safety (5g/day n=11) and (test 5) a 4 month noncomparative study in 21 hypercholesterolemic patients ingesting 1g/day. Results shows safety study no changes in heamatological or relevent parameters. In test 5 significant reduction in total and low dencity lipoprotein cholestrol levels accompanied by significant decrease in body weight were observed without affecting other biochemical parameters. They concluded BTE significantly reduced blood cholesterol level in humans and prove safe and useful in preventing and improving metabolic syndrome induced arteriosclerosis and obesity.38

A double blind, randomised, placebo controlled, parallel group trail set in outpatient clinics in 6 urban hospitals in China. A total of 240 men and women 18 years or to moderate hypercholesterolemia. Were randomly assigned to receive a daily capsule containing theaflavin enriched tea extract (375 mg) or with baseline results shows after 12 weeks, the mean SEM changes from baseline in total cholestrol, LDL-C, HDL-C and triglyceride levels were -11.3% + /-0.9% (P=01) -16.4% + /-1.1% (P=01) 2.3%+/-2.1% (P=27) and 2.6%+/-3.5% (p=47) respectively in the tea extract group. The mail levels of total cholesterol LDL-C and triglycerides didnot change significantly in the placebo group. No significant adverse events were observed. They concluded theaflavin enriched tea extract is effective to reduce LDL-C in hypercholeserolemic adults. 39

A study was done to find out the effect of black tea on thermo genesis 10 volunteers receiving at each meal either 500 mg of an extract tea (corresponding to 125 mg of catechols and 50 mg of caffein) or 50 mg of caffeine or a placebo. The total expenditure of energy over 24 hours showed a statistically significant increase (p= 0.01) in favour of the extract 9867 KJ compared with 9538 KJ for the placebo and 4599 KJ for caffeine. This results demonstrate the ability of a tea extract significantly increase thermo genesis. This property is not associated with the caffeine content of the extract, since administration of caffeine alone at the same dose as that provide by the extract of tea does not increase thermo genesis40A study published in the American journal of clinical nutrition found that tea extract significantly increase energy expenditure in adults while also boosting fat burning. When men supplemented with 90 mg of EGCG and 50 mg of caffeine three times daily, their 24 hours energy expenditure increase by 4%. The supplemented men thus burned 79 more calories a day than men who did not supplement. The increase in energy expenditure came from burning fat, as opposed to a breakdown of protein (muscle) mass. These important findings suggest that tea extract can be an important tool in maintaining healthy body weight and composition.41

Another study lends to tea’s role in healthy weight control in humans. In this trial, moderately obese adults supplemented with a tea extract. After months, they demonstrated a 4.6% decrease in body weight and 4.5% decrease in waist circumference. This important study demonstrates that tea effectively supports healthy body mass and protects against dangerous excess weight around the abdomen, which is risk factor for metabolic syndrome. 42

Statement of the problem

Effectiveness of black tea on selected physiological parameters among hypercholesterolemic adults in selected IT industry, Bangalore, Karnataka.

6.3. Objectives of the study

1. To assess the pre test physiological parameters among hypercholesterolemic adults working in IT industry.

2. To findout the effectiveness of black tea on selected physiological parameters in hypercholesterolemic adults working in IT industry.

3. To associate the post test physiological parameters of hypercholesterolemic adults with their selected demographic variables.

Operational definitions

ASSESS:

It refers to the statistical difference with the pre test and post test physiological parameters of hypercholesterolemic adults with regard to black tea consumption.

EFFECTIVENESS

It refers to the statistical changes in the pre test physiological parameters with regard to black tea consumption.

BLACK TEA

It is a beverage made by soaking dried tea leaves (two teaspoons) in one glass of (250ml)hot water (80-90degree centigrade) with appropriate quantity of sugar which will be given three times a day for a period of 7 days .

PHYSIOLOGICAL PARAMETERS

It refers to those measures which includes both in vivo-

Body mass index which is measured by using inch tape for assessing height and a weighing scale is used to assess weight.

Blood pressure both systolic and diastolic which is measured by using sphygmomanometer.

And invitro measurements like total blood cholesterol which is assessed by collecting the blood sample and sent for labortary analysis.

HYPERCHOLESTEROLEMIC ADULTS:

It refers to the employees above 25 years of age with their blood cholesterol level > 150mg/dl working in the selected IT industry, Bangalore.

Hypothesis

H1:- There will be significant difference in the pre test and post test physiological parameters among hypercholesterolemic adults.

H2: .There will be significant association between the post test physiological parameters of hypercholesterolemic adults and their selected demographic variables.

Assumptions

1. The IT employees are having some knowledge about hypercholesterolemia.

2.May black tea have an effect on hypercholesterolemia.

Limitations

Study is limited to

1. IT Employees with hypercholesterolemia working in selected IT industry in Bangalore.

7. Materials and methods:

|7.1: SOURCES OF DATA |Employees in selected IT industries in Bangalore. |

|7.2: METHODS OF DATA COLLECTION |The research design which will be adopted for this study is Pre – |

|RESEARCH DESIGN AND APPROACH |experimental design with one group pre and post test design. |

| | |

|SETTING | Study will be conducted in selected IT industry in Bangalore |

|POPULATION |The population of the present study will be the hypercholesterolemic |

| |adults of IT industries |

|SAMPLE |hypercholesterolemic adults of selected IT industries in Bangalore |

|SAMPLE SIZE |40 |

|SAMPLING TECHNIQUE | Purposive sampling technique will be used to select the samples for|

| |the study. |

|INCLUSION CRITERIA |IT employees those who are, |

| |Available during the time of data collection. |

| |Willing to participate in the study |

| |Having hypercholesterolemia |

| |Both males and females |

|EXCLUSION CRITERIA |IT employees those who are, |

| |IT employees diagnosed to have major health problems associated with |

| |hypercholesterolemia such as heart disease or diabetes mellitus |

| |Taking prescription medication that could interfere with lipid |

| |metabolism |

| |People with known allergy /hypersensitivity to caffeine or tannin |

|DATA COLLECTION TOOL |SECTION A:Structured questionnaire to assess demographic data of |

| |hypercholesterolemic adults working in IT industry |

| |SECTION B:Biophysiological measures |

| |Which includes both invivo- |

| |Body mass index which is measured by using inch tape for assessing |

| |height and a weighing scale is used to assess weight. |

| |Blood pressure both systolic and diastolic which is measured by using|

| |sphygmomanometer. |

| |And invitro measurements like total blood cholesterol which is |

| |assessed by collecting the blood sample and sent for laboratory |

| |analysis. |

|METHODE OF DATE COLLECTION |Prior to data collection permission will be obtained from concerned |

| |authority consent will be obtained from the IT employees prior to |

| |the conduction of the study .data will be collected by the |

| |investigator himself by using structured questionnaire& |

| |biophysiolocal assessments before intervention ie black tea it is |

| |abeverage made by soaking dried tea leaves (two teaspoons) in one |

| |glass of (250ml)hot water (80-90degree centigrade) with appropriate |

| |quantity of sugar which will be given three times a day for a |

| |period of 7 days . after 7 days investigator himself will collect |

| |data to find out effectiveness. |

| DATA ANALYSIS METHODS. |The collected data will be organized by |

| |1. Descriptive statistics: Frequency distribution, percentage, mean, |

| |and standard deviation will be used to assess the demographic |

| |variables and the pre-test and post-test scores. |

| |2. Inferential statistics: |

| |Paired t-test will be used to compare the pre-test and post- scores |

| |Chi-square test will be used to determine the association of |

| |post-test scores with the selected demographic variables. |

| |Analyzed data will be presented in the form of tables, diagrams, |

| |graphs based on the findings |

7.3: DOES THE STUDY REQUIRED ANY INVESTIGATIONS OR INTERVENTION TO BE CONDUCTED ON PATIENTS OR OTHER HUMANS OR ANIMALS? IF SO, PLEASE DESCRIBE BRIEFLY.

YES- Effect of black tea on selected physiological parameters will be assessed among hypercholesterolemic adults in IT industry

7.4 Yes, informed consent will be obtained from concerned authority of institution and subject prior to study, Privacy, confidentiality and anonymity will be guarded. Scientific objectivity of the study will be maintained with honesty and impartiality

Ethical Committee

|Title of the topic |Effectiveness of black tea on selected physiological parameters among|

| |hypercholesterolemia adults in selected I.T industry in Bangalore. |

|Name of the Candidate |Mr.BINESH .P.C |

|Course of the study and subject |M.Sc. (N) 1st year. |

| |Medical Surgical Nursing. |

| |Prof. Vasantha Chitra.D |

|Name of the guide |Head of the Department |

| |Department of Medical Surgical Nursing, Diana College of Nursing, |

| |Bangalore – 64. |

|Ethical committee |Approved |

Members of Ethical committee:

1. Prof. Veda vivek

Principal and HOD

Department of Community Health Nursing

Diana College of Nursing, Bangalore – 64.

2. Prof. Elizabeth Dora

Head of the Department

Department of Child Health Nursing

Diana College of Nursing, Bangalore – 64.

3. Prof. Kalaivani

Head of the Department

Department of Obstetrics and Gynecological Nursing

Diana College of Nursing, Bangalore – 64.

4. Prof. Vasantha Chitra.D

Head of the Department

Department of Medical Surgical Nursing

Diana College of Nursing, Bangalore – 64

5. Prof. Kalai Selvi. S.

Head of the Department

Department of Psychiatric Nursing

Diana College of Nursing, Bangalore – 64.

6. Prof. Rangappa

Biostatistician GKVK,

Jakkur International Airport Road Bangalore

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| | |

|9.Signature of candidate | |

| |THERE IS AN INCREASE IN PREVALENCE IN HYPERLIPIDEMIA IN INDIA. HENCE THE |

|10. Remarks of the guide |RESEARCH TOPIC SELECTED FOR THE CANDIDATE IS SUITABLE. |

|11.Name and designation of guide |Prof. Vasantha Chitra.D |

| |Head of the Department |

| |Department of Medical Surgical Nursing, |

| |Diana College of Nursing, |

| |Bangalore – 64. |

| | |

|Signature | |

| |Prof. Vasantha Chitra.D |

|HOD |Head of the Department |

| |Department of Medical Surgical Nursing, |

| |Diana College of Nursing, |

| |Bangalore – 64. |

|Signature | |

|12. Remarks of the chairman & principal | |

| | |

|Signature | |

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