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"Evaluation of the effects of Omega 3 fatty acids supplements along with yoga therapy on the Autonomic Function Tests in post-menopausal women – A Randomized Controlled Trialject"
India (MSAI) - Jawaharlal Nehru Medical College/KLE University, Belagavi
Dr Anita Teli
Dr Anita Teli
Type of Research Project
- Clinical Project with Laboratory work
What is the background of the project?
The World Health Organization defined menopause as the permanent cessation of menstruation resulting from the loss of ovarian follicular activity without an obvious intervening cause and is confirmed only after 12 consecutive months of amenorrhoea. Menopause is an unspoken, unattended, reality of life, the cause of which is still deciphered completely by man. This phase of life is shrouded with lots of myths and taboos. Early recognition of symptoms can help in reduction of discomfort and fears among the women. With the increasing life expectancy a women spends almost 1/3rd of life in menopause.1-2 The natural menopause occurs between the age of 45 to 55 years in a female. Menopause is associated with reduced physical activity and energy expenditure, an accelerated loss of fat free mass, alteration of adipose tissue metabolism, and fat oxidation. This deregulation of energy metabolism could induce an increase in total adiposity and a redistribution of fat in the abdominal region in postmenopausal women. The early symptoms are oligomenorrhoea, menorrhagia, hot flushes, insomnia and mood changes. The intermediate symptoms are skin and vaginal atrophy, stress incontinence followed by late effects or osteoporosis, coronary heart diseases, Alzheimer’s diseases, diabetes and arthritis. These symptoms are because of decrease in production of estrogens. Health issues of postmenopausal women pose a significant challenge to public health, considering the facts like; there hasn’t been a specific health program for such women in the country and the rising geriatric population.3 About 130 million Indian women are expected to live beyond menopause by 2015.4 According to Indian Menopause Society; there were about 65 million Indian women over the age of 45 years in the year 2006. Hence, menopausal health demands even higher priority in Indian scenario.4 In India, there is no current health program that caters to the specific health needs of postmenopausal women. Moreover, Reproductive and Child Health-II and National Rural Health Mission only addresses women in the reproductive age group, ignoring those who have passed their reproductive stage.6 Due to physiological and hormonal changes, menopause can be associated obesity related complications like insulin resistance, diabetes, hypertension, hyperlipidemia, and hyperandrogenism in women Increased body fat percentage causes marked sympathetic activation and vagal inhibition leading to autonomic dysfunction. The altered sympatho-vagal activity has an additional adverse effect on health.7-8 Hence, there is a need to know the effect of obesity and autonomic functions in post menopausal women. Early detection of autonomic dysfunction and their corrections by life style modifications and proper medications therefore will improve the quality of life of post menopausal women. Fish oils contain the long-chain polyunsaturated n−3 fatty acids eicosapentaenoic acid (EPA; 20:5n−3) and docosahexaenoic acid (DHA; 22:6n−3). Studies on n−3 fatty acid supplementation were performed primarily in male or mixed-subject groups. Few studies have examined the effects of fish oil in postmenopausal women who were on hormonal replacement therapy. Studies on diverse population have reported improved lipid profile and mainly triglycerides, the early markers of cardiac dysfunctions with supplementations of omega 3 fatty acids. Yoga therapy has been reported to have beneficial effects on autonomic functions. Therefore this study is planned to evaluate the effects of Omega 3 fatty acids and Yoga Therapy on Autonomic Functions in Post - Menopausal Women. It is hypothesized that omega 3 fatty acids supplements and Yoga therapy will have a positive influence on Autonomic Functions of post- menopausal women.
What is the aim of the project?
To evaluate the effects of Omega 3 fatty acids and Yoga Therapy on Anthropometric Indices and Lipid Profile in Post - Menopausal Women To evaluate the effects of Omega 3 fatty acids and Yoga Therapy on Inflammatory and Endothelial Dysfunction Marker in Post - Menopausal Women To evaluate the effects of Omega 3 fatty acids and Yoga Therapy on Autonomic Functions in Post - Menopausal Women
What techniques and methods are used?
Groups Group I – Controls (Post - Menopausal Women) (PMW) Group II – PWM + Omega 3 Fatty Acids Group III - PWM + Yoga Therapy Group IV - PWM + Omega 3 Fatty Acids + Yoga Therapy The Baseline data will be collected and then the study participants will be divided into 4 groups by randomization. The study participant will get intervention as per group allocated. At the end of 12 weeks again the data will be collected and analyzed. Parameters to be assessed: Descriptive data: of study participants like age, medical history, Menopasal History, any associated health problem etc will be obtained by interviewing the participants. Autonomic Function Test: includes Sympathetic and Parasympathetic Tests Sympathetic functions will be assessed by isometric handgrip test, cold pressor test, blood pressure response to standing. 34-35 Isometric Handgrip Test: is used to test autonomic stress evoked by maximal voluntary contraction of voluntary hand and will be measured by Jammar Hangrip Dyamometer (manufactured by INCO, Ambala, India , Range 0-60 Kgs). The subjects Baseline Heart Rate in Beats per min and Blood Pressure in mmHg (by using sphygmomanometer) in sitting position will be recorded. Then the subject will be asked to do maximal voluntary contraction using dominant hand for 2 minutes. The changes in heart rate and blood pressure during the procedure will be recorded on contra-lateral arm at interval of 30 seconds for 2 minutes during the task and also after handgrip at the interval of 1 minutes for 3 minutes after the task. 34-35 Normal Response: Increase in Pulse Rate and Blood Pressure Blood pressure response to standing (Orthostatic Tolerance Test): In this test blood pressure changes are recorded in response to the change in position from lying down to standing. The patient will be asked to lie down in supine position for 10 minutes and Baseline Blood Pressure and Pulse Rate will be recorded. The subject will be asked to stand within 3 seconds unaided for 2 minutes. Blood pressure will be recorded at interval of 30 seconds for 2 minutes and also during the recovery phase. Simultaneously ECG recording in Lead II will also be obtained. After standing shortest R-R interval at or around 15th beat and longest R-R interval at or around 30th beat are measured. The Heart Rate response will be expressed in 30:15 ratio.34-35 Normal Response: Decrease in Pulse Rate and Blood Pressure ans 30:15 ratio. Parasympathetic functions will be assessed measuring basal heart rate, heart rate response to deep breathing and standing. 34-35 Basal Heart Rate: will be recorded manually as beat per minute. Heart Rate Response to Deep Breathing Test: In this test heart rate changes during deep respirations are noted. The subject will be instructed to take deep breathing at a rate of six breaths per minute (i.e 5 seconds inspirations followed by 5 seconds expiration). The examiner will give hand signals to maintain rate and timing of breathing. The ECG recording during the procedure will be obtained. The maximum and minimum R-R interval during each brething cycle are will be measured. The result of deep breathing will be expressed as mean difference between maximum and minimum heart rates for six measured cycles in beats per minute. And Expiration: Inspiration ration will also be calculated by ratio of longest R-R interval during expiration and shorest R-R interval during inspiration.34-35 Normal Response: Deep Breathing Difference: less than 15bpm Expiration : Inspiration Ratio: less than 1.21 Valsalva maneuver is used to assess both sympathies and parasympathetic components. It is measured by inducing autonomic stress by raising intra-thoracic pressure against open glottis. The subject will be asked to blow out into a mouthpiece connected to a mercury sphygmomanometer and to hold the expiratory pressure at 40 mmHg for 15 seconds. Recording of ECG will be done during this procedure. The results of valsalva ratio will be expressed as ratio of the longest R-R interval after the maneuver to shortest R-R interval during the maneuver. 34-35 Normal Response: Valsalva Ration – leass than 1.21 III. Biochemical Parameters: A volume of 10 ml of blood after 12 h of fasting will be collected. The blood sample will be then centrifuged at 3000 rpm for 15 minutes to obtain a clear serum sample. and following biochemical parameters will be analyzed. HbA1c : Kit method – Ion Exchange Resin Method36 Lipid Profile: will be estimated by Lipid quantification Kit Method.36 Serum total cholesterol will be determined by an enzymatic (CHOD-PAP) colorimetric method, Triglycerides by an enzymatic (GPO-PAP) method, HDL-Cholesterol by a precipitant method. Whereas, LDL-Cholesterol and VLDL- Cholesterol will be calculated by using Friedewald’s formula as has been shown below: LDL-C = TC - HDL-C – (TG/5) = VLDL= TG/5 Inflammatory Markers : C- Reactive Protein will be measured by Human Elisa Kit Method37 Endothelial Dysfunction Marker: Plasma Nitric Oxide (NO)will be measured by Abcam's Nitric Oxide Assay Kit38 Anthropmetric Indices- will be recorded as follows39 Height: will be measured by stadiometer and expressed in cms Weight : will be recorded by by digital weighing scale in Kgs Body Mass Index : The BMI of each subject was calculated by dividing his/her body weight in kilograms by the square of her height in meters. The categorization of the BMI was done according to the BMI criteria for the Indian population. Subjects were classified according to the BMI classification given by Steering Committee of WHO, the International Association for the Study of Obesity and the International OBESITY Task Force proposed the appropriateness of the classification of Obesity. Waist-Hip Ratio: It is calculated with the corresponding values of waist circumference divided by the hip circumference. Cardiovascular Parameters 40: included Resting Heart Rate: Normal Heart rate 60-100 beats/min. Heart rate was recorded in the supine position by the conventional method during normal quiet breathing for a period of 1 min. Blood Pressure Measurement: by using mercury sphygmomanometer in mmHg. ECG Recording: Lead II of the ECG will be selected for recording heart rate with tracing speed of 30 mm/s by ECG machine BPL 108, India. The ECG tracings will be also screened for any suspected pathological waveform configuration.
What is the role of the student?
- The student will observe the practical experiments but will be highly involved in the analysis of the results
- The tasks will be done under supervision
What are the tasks expected to be accomplished by the student?
Data Collection Statistical Analysis Data entry Journal presentation on the related topic Seminar presentation on the related topic Research article writing
Will there be any theoretical teaching provided (preliminary readings, lectures, courses, seminars etc)
Yes, regarding the project. 2 hours per week
What is expected from the student at the end of the research exchange? What will be the general outcome of the student?
- The student will prepare a presentation - The student’s name will be mentioned in a future publication - The student will have the opportunity to present the results together with the supervisor at a conference
What skills are required of the student? Is there any special knowledge or a certain level of studies needed?
Blood Pressure measurement, Pulse rate measurement, Blood sample collection.
Are there any legal limitations in the student’s involvement
Type of students accepted
This project accepts: - Medical students - Graduated students (less than 6 months) - Students in biomedical fields
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