An interventional study of Indian version of a 'Portfolio' diet and Physical Activity in Lifestyle Risk Reduction, Cholesterol, Elevated and LDL Hyperlipoproteinemia, sponsored by Jubilee Mission Medical College and Research Institute. Active, not recruiting at 1 site in India. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-20.
Sponsored by Jubilee Mission Medical College and Research Institute · Not applicable, Interventional, and Prevention
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.
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
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:
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
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.
291 studies on the registry are indexed under Risk Reduction Behavior; 39 are open to participants now.
This study's planned enrollment of 50 is below the median of 201 across 250 interventional studies indexed under Risk Reduction Behavior.
Browse Risk Reduction Behavior studies →Jubilee Mission Medical College and Research Institute is the lead sponsor of 25 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: All willing Indian doctors and their family aged between 18 and 70 years
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Behavioral: Indian version of a 'Portfolio' diet · Behavioral: Physical Activity · Behavioral: Intermittent fasting · Behavioral: Monitoring of sleep and stress levels
The participants will be required to follow the prescribed diet plan for 4 weeks
Also known as: Indian version of a dietary portfolio of cholesterol lowering foods
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)
Also known as: Exercise, Workout
The participants will be required to do intermittent fasting for 12 hours daily for 4 weeks
Also known as: Time Restricted Eating
The participants will be required to monitor their sleep and stress levels
Changes in the blood lipid levels
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
Time frame: 4 weeks
Changes in the anthropometric and biochemical parameters
The effect of a customised lifestyle intervention technique on changes in Blood Pressure, Weight, BMI, HbA1C levels, Blood HS CRP levels and Other blood Parameters including Lipoprotein A
Time frame: 4 weeks
Started Feb 2024 (actual). Primary completion is estimated for May 2024, 3 months after the start.
Of 167 non-industry interventional studies with no phase under Risk Reduction Behavior, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 42. This study's planned 3 months is below that.
Counting every sponsor, half of 169 studies reached it within 25 months; a quarter within 13 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Jubilee Mission Medical College and Research Institute