Effect of a Customised Lifestyle Medicine Strategy on Lowering Blood Lipid Levels in Indian Physicians
NCT ID: NCT06420817
Last Updated: 2024-05-20
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
ACTIVE_NOT_RECRUITING
Clinical Phase
NA
Total Enrollment
50 participants
Study Classification
INTERVENTIONAL
Study Start Date
2024-02-15
Study Completion Date
2024-08-15
Brief Summary
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Lifestyle medicine is a medical specialty that uses evidence-based therapeutic interventions to prevent, treat, and reverse chronic conditions. Studies have shown that a 50 mg/dl reduction in LDL reduces the risk of developing stroke by 20%, and a 10 mm Hg reduction in systolic BP reduces the risk of developing MACE by 22% and stroke by 41%. The CLIP (Cholesterol Lowering Lifestyle Intervention Project) is an innovative initiative proposed to evaluate the combined effect of an Indian version of Portfolio diet-based nutrition strategy, intermittent fasting, exercise, sleep, and stress reduction techniques on lowering blood lipid levels in health professionals and their family. The study aims to evaluate the effect of CLIP on changes in blood pressure, weight, HbA1C levels, blood CRP levels, and other blood parameters.
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Detailed Description
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Lifestyle medicine is a medical specialty that uses evidence based therapeutic lifestyle interventions as a primary modality to prevent, treat and often reverse chronic conditions using whole food plant-based diet, physical activity, restorative sleep, stress reduction, avoiding risky substances and positive social connections with or without medications.
Epidemiological and interventional studies have shown clearly that a 50 mg/dl reduction in LDL reduces the risk of developing stroke by 20% and a 10 mm Hg reduction in systolic BP reduces the risk of developing MACE by 22% and the risk of developing stroke by 41%.(Enas EA, et al, Indian Heart Journal, 2011, cadiresearch.org,) Studies by the nutrition expert David J.A. Jenkins and colleagues from Toronto University have shown that grouping plant based whole foods, which have their own cholesterol lowering ability when eaten alone, will have a larger effect when they are eaten together or combined into a "portfolio" as part of a regular diet (https://jamanetwork.com/journals/jama/fullarticle /196970). The 'portfolio diet' plan has been subsequently shown to reduce cholesterol similar to powerful cholesterol-lowering drugs without any side effects in various other studies as well. However, no study has so far looked at the effects of this diet on Indian population. Also, no reported study in the world so far has looked at the effects of a combination of lifestyle medicine interventions including the Indianized version of portfolio diet on the reduction of lipid levels in health care workers CLIP (Cholesterol lowering Lifestyle Intervention Project) is an innovative lifestyle medicine intervention project that we propose to carry out under the academic guidance of the Dept of Lifestyle Medicine , CMC, Vellore.
Research Question: Will a customised lifestyle medicine strategy over a period of 4 weeks lower blood lipid levels significantly in adults between 18 and 70 years?
Null Hypothesis: A customised lifestyle medicine strategy over a period of 4 weeks will not significantly lower blood lipid levels in adults between 18 and 70 years Type of study: A Quasi Experimental Study
Time duration:
Preparation: 4 weeks Intervention: 4 weeks Result compilation and analysis: 4 months Total: 6 months
AIM: To evaluate the combined effect of an Indian version of Portfolio diet-based nutrition strategy, Intermittent fasting, Exercise, Sleep and Stress Reduction Techniques on lowering blood lipid levels in health professionals and their family
Secondary objectives: To evaluate the effect of the CLIP interventions on the changes in
* Blood Pressure
* Weight
* HbA1C levels
* Blood CRP levels
* Other blood Parameters including Lipo A
The study would be done in 2 phases. In the first phase the pretest questionnaire would be administered through google forms and health education on whole food plant-based diet, physical activity, restorative sleep, stress reduction \& avoiding risky substances would be given.
In the second phase Intervention would be carried out and monitoring would be done online daily / weekly by the investigative team.
Population: Willing members of health professionals and their family Inclusion Criteria: All willing health professionals and their family aged between 18 and 70 years
Exclusion Criteria:
* Those who have been started on any medication for chronic illnesses unless sufficient period (3 months) is over for stabilization of parameters on those medications.
* People on insulin, steroids and warfarin.
* Those who alter their medications during the intervention
* Those who are unfit to exercise
Methods:
Enrolment and Training:
All the participants who meet the criteria for the study will be enrolled from an already existing WhatsApp group of Modern Medicine doctors and their family interested in lifestyle interventions.
The study protocol will be familiarised online through social media platforms on the basic concepts of lifestyle medicine in general and the interventions adopted in particular, before the commencement of the intervention.
Consenting members will be enrolled in the study and will undergo the following interventions:
I. Baseline Screening: The following parameters will be evaluated (by the participants) during the preparation stage before the commencement of the intervention:
Anthropometry \& Clinical: Height, Weight, Waist Circumference, Waist to Hip Ratio, BP Biochemistry: Lipid Profile, Apolipoprotein B, Lipoprotein A, HbA1C, Blood sugar (Fasting and PP), CRP, LFT, RFT, Uric Acid, TSH
II. Lifestyle Interventions: The participants will be supervised to
* follow the prescribed diet plan
* do intermittent fasting for 12 hours daily and
* join for an hour of group online exercise program 3 days a week.
* Monitor the sleep duration as per PSQI (Pittsburgh sleep quality index) scores
* (Exercise Duration = 180 minutes per week including cardio, strength training and flexibility)
* Compliance: Adherence to all interventions planned will be monitored through a weekly questionnaire, software like habit tracker and online Zoom meetings
III. Final Evaluation: Final Anthropometry, Clinical and Biochemical Parameters achieved will be obtained at the end of 4 weeks. (Pre and post biochemical evaluation will be done by the participants in the same lab)
Expected outcome of the study: It is expected that diet and other lifestyle interventions included in the study will lower total cholesterol and LDL levels (primary outcomes) of the participants in proportion to their degree of compliance to interventions.
1. Proportion of participants achieving reduction in BMI \& Waist to Hip Ratio
2. Proportion of hypertensive participants achieving reduction in BP
3. Proportion of DM participants achieving reduction in HbA1C
4. Proportion of participants achieving reduction in TC \& LDL levels
5. Proportion of participants achieving reduction in all the other biochemical parameters studied
Epidemiological and interventional studies have shown clearly that a 50 mg/dl reduction in LDL reduces the risk of developing stroke by 20% and a 10 mm Hg reduction in systolic BP reduces the risk of developing MACE by 22% and the risk of developing stroke by 41%.(Enas EA, et al, Indian Heart Journal, 2011, cadiresearch.org,) Studies by the nutrition expert David J.A. Jenkins and colleagues from Toronto University have shown that grouping plant based whole foods, which have their own cholesterol lowering ability when eaten alone, will have a larger effect when they are eaten together or combined into a "portfolio" as part of a regular diet (https://jamanetwork.com/journals/jama/fullarticle /196970). The 'portfolio diet' plan has been subsequently shown to reduce cholesterol similar to powerful cholesterol-lowering drugs without any side effects in various other studies as well. However, no study has so far looked at the effects of this diet on Indian population. Also, no reported study in the world so far has looked at the effects of a combination of lifestyle medicine interventions including the Indianized version of portfolio diet on the reduction of lipid levels in health care workers CLIP (Cholesterol lowering Lifestyle Intervention Project) is an innovative lifestyle medicine intervention project that we propose to carry out under the academic guidance of the Dept of Lifestyle Medicine , CMC, Vellore.
Research Question: Will a customised lifestyle medicine strategy over a period of 4 weeks lower blood lipid levels significantly in adults between 18 and 70 years?
Null Hypothesis: A customised lifestyle medicine strategy over a period of 4 weeks will not significantly lower blood lipid levels in adults between 18 and 70 years Type of study: A Quasi Experimental Study
Time duration:
Preparation: 4 weeks Intervention: 4 weeks Result compilation and analysis: 4 months Total: 6 months
AIM: To evaluate the combined effect of an Indian version of Portfolio diet-based nutrition strategy, Intermittent fasting, Exercise, Sleep and Stress Reduction Techniques on lowering blood lipid levels in health professionals and their family
Secondary objectives: To evaluate the effect of the CLIP interventions on the changes in
* Blood Pressure
* Weight
* HbA1C levels
* Blood CRP levels
* Other blood Parameters including Lipo A
The study would be done in 2 phases. In the first phase the pretest questionnaire would be administered through google forms and health education on whole food plant-based diet, physical activity, restorative sleep, stress reduction \& avoiding risky substances would be given.
In the second phase Intervention would be carried out and monitoring would be done online daily / weekly by the investigative team.
Population: Willing members of health professionals and their family Inclusion Criteria: All willing health professionals and their family aged between 18 and 70 years
Exclusion Criteria:
* Those who have been started on any medication for chronic illnesses unless sufficient period (3 months) is over for stabilization of parameters on those medications.
* People on insulin, steroids and warfarin.
* Those who alter their medications during the intervention
* Those who are unfit to exercise
Methods:
Enrolment and Training:
All the participants who meet the criteria for the study will be enrolled from an already existing WhatsApp group of Modern Medicine doctors and their family interested in lifestyle interventions.
The study protocol will be familiarised online through social media platforms on the basic concepts of lifestyle medicine in general and the interventions adopted in particular, before the commencement of the intervention.
Consenting members will be enrolled in the study and will undergo the following interventions:
I. Baseline Screening: The following parameters will be evaluated (by the participants) during the preparation stage before the commencement of the intervention:
Anthropometry \& Clinical: Height, Weight, Waist Circumference, Waist to Hip Ratio, BP Biochemistry: Lipid Profile, Apolipoprotein B, Lipoprotein A, HbA1C, Blood sugar (Fasting and PP), CRP, LFT, RFT, Uric Acid, TSH
II. Lifestyle Interventions: The participants will be supervised to
* follow the prescribed diet plan
* do intermittent fasting for 12 hours daily and
* join for an hour of group online exercise program 3 days a week.
* Monitor the sleep duration as per PSQI (Pittsburgh sleep quality index) scores
* (Exercise Duration = 180 minutes per week including cardio, strength training and flexibility)
* Compliance: Adherence to all interventions planned will be monitored through a weekly questionnaire, software like habit tracker and online Zoom meetings
III. Final Evaluation: Final Anthropometry, Clinical and Biochemical Parameters achieved will be obtained at the end of 4 weeks. (Pre and post biochemical evaluation will be done by the participants in the same lab)
Expected outcome of the study: It is expected that diet and other lifestyle interventions included in the study will lower total cholesterol and LDL levels (primary outcomes) of the participants in proportion to their degree of compliance to interventions.
1. Proportion of participants achieving reduction in BMI \& Waist to Hip Ratio
2. Proportion of hypertensive participants achieving reduction in BP
3. Proportion of DM participants achieving reduction in HbA1C
4. Proportion of participants achieving reduction in TC \& LDL levels
5. Proportion of participants achieving reduction in all the other biochemical parameters studied
Conditions
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Lifestyle Risk Reduction
Cholesterol, Elevated
LDL Hyperlipoproteinemia
Hypertension
Lipoprotein(A)
HbA1C
BMI
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
The study would be done in 2 phases. In the first phase the pretest questionnaire would be administered throughGoogle forms and health education on various Lifestyle Medicine interventions would be given. In the second phase Intervention would be carried out and monitoring would be done online daily / weekly by the investigative team.
The following five strategies of lifestyle medicine will be tried to lower the lipid levels in the study group:
1. Nutrition - modified/Indianized Portfolio diet - (Primary Intervention)
2. adequate exercise - 180 minutes of moderate intensity exercises every week
3. intermittent fasting of 12 hours every day
4. sleep monitoring and
5. monitoring stress levels
The following five strategies of lifestyle medicine will be tried to lower the lipid levels in the study group:
1. Nutrition - modified/Indianized Portfolio diet - (Primary Intervention)
2. adequate exercise - 180 minutes of moderate intensity exercises every week
3. intermittent fasting of 12 hours every day
4. sleep monitoring and
5. monitoring stress levels
Primary Study Purpose
PREVENTION
Blinding Strategy
NONE
Study Groups
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Lifestyle Interventions
Lifestyle Interventions (a prescribed whole food plant-based diet, physical activity and intermittent fasting along with monitoring of sleep and stress levels) would be carried out to the enrolled participants
Group Type
EXPERIMENTAL
Indian version of a 'Portfolio' diet
Intervention Type
BEHAVIORAL
The participants will be required to follow the prescribed diet plan for 4 weeks
Physical Activity
Intervention Type
BEHAVIORAL
The participants will be required to join for an hour of group online exercise program 3 days a week for 4 weeks
• (Exercise Duration = 180 minutes per week including cardio, strength training and flexibility)
Intermittent fasting
Intervention Type
BEHAVIORAL
The participants will be required to do intermittent fasting for 12 hours daily for 4 weeks
Monitoring of sleep and stress levels
Intervention Type
BEHAVIORAL
The participants will be required to monitor their sleep and stress levels
Interventions
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Indian version of a 'Portfolio' diet
The participants will be required to follow the prescribed diet plan for 4 weeks
Intervention Type
BEHAVIORAL
Physical Activity
The participants will be required to join for an hour of group online exercise program 3 days a week for 4 weeks
• (Exercise Duration = 180 minutes per week including cardio, strength training and flexibility)
Intervention Type
BEHAVIORAL
Intermittent fasting
The participants will be required to do intermittent fasting for 12 hours daily for 4 weeks
Intervention Type
BEHAVIORAL
Monitoring of sleep and stress levels
The participants will be required to monitor their sleep and stress levels
Intervention Type
BEHAVIORAL
Other Intervention Names
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Indian version of a dietary portfolio of cholesterol lowering foods
Exercise
Workout
Time Restricted Eating
Eligibility Criteria
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Exclusion Criteria
* Those who have been started on any medication for chronic illnesses unless sufficient period (3 months) is over for stabilization of parameters on those medications.
* People on insulin, steroids and warfarin.
* Those who alter their medications during the intervention
* Those who are unfit to exercise
* People on insulin, steroids and warfarin.
* Those who alter their medications during the intervention
* Those who are unfit to exercise
Minimum Eligible Age
18 Years
Maximum Eligible Age
70 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Christian Medical College, Vellore, India
OTHER
Sponsor Role
collaborator
Jubilee Mission Medical College and Research Institute
OTHER
Sponsor Role
lead
Responsible Party
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Dr. Manoj Varanattu
Professor of Pediatrics & Neonatology
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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Manoj Varanattu
Thrissur, Kerala, India
Site Status
Countries
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India
References
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Other Identifiers
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CLIP
Identifier Type: -
Identifier Source: org_study_id
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NCT03698929
COMPLETED
NA
Effects of Whole Grain on Weight Maintenance
NCT01239147
COMPLETED
PHASE3
Effect of Consumption of Millet Diet in Patients With NAFLD
NCT06341790
NOT_YET_RECRUITING
NA
Low Fat Plant-based Diet Effects on Body Composition Indices
NCT02906072
COMPLETED
NA
Optimal Dietary Fat Pattern to Prevent Cardiovascular Disease Among Type 2 Diabetes
NCT00467168
COMPLETED
PHASE1/PHASE2
Soy and Brain Vascular Function
NCT03627637
COMPLETED
NA
Impact of Almond Supplementation on Body Composition in Overweight/Obese Minority Adults
NCT02347007
COMPLETED
NA
Dietary Intervention With Brain-friendly Diet
NCT03346486
COMPLETED
NA
Effects of Nutritional Counseling Regularity on the Risk of Cardiovascular Diseases
NCT05092087
COMPLETED
Nutrition Interventions for Cognitive Enhancement
NCT03841539
COMPLETED
NA
Fatty Acid Modulation of Brain Function in Older Adults
NCT06192407
RECRUITING
NA
Oat and Cholesterol
NCT03911427
COMPLETED
NA
Impact of Low-fat and Full-fat Milk on Lipids and Cardiac Function in Patients With Coronary Artery Disease
NCT06542172
COMPLETED
NA
Soy Nuts and Cardiovascular Risk in Postmenopausal Women
NCT01740076
COMPLETED
NA
Low Fat Vegan or American Heart Association Diets & Cardiovascular Risk in Obese 9-18 y.o. With Elevated Cholesterol
NCT01817491
COMPLETED
NA
Saturated Fatty Acids and HDL Metabolism
NCT02835651
COMPLETED
NA
Lentils as a Functional Food to Improve Glucose and Decrease Cardiovascular Risk
NCT01562171
COMPLETED
NA
Effect of Low Calorie Diet With Rice Bran Oil on Cardiovascular Risk Factors in Hyperlipidemic Patients
NCT01600313
UNKNOWN
NA
Oil Consumption and Cholesterol
NCT04397055
COMPLETED
NA
Plant-Based, American Heart Assoc. or Mediterranean Diets In 9-18 yo With BMI >95%, Cholesterol >169 and Their Parents
NCT02857543
COMPLETED
NA
Effects of a 4-week Raw, Plant-based Diet on Anthropometric and Cardiovascular Risk Factors
NCT03134235
COMPLETED
NA