Clinical trial NCT06420817: Effect of a Customised Lifestyle Medicine Strategy on Lowering Blood Lipid Levels in Indian Physicians
Official title: Effect of a Customised Lifestyle Medicine Strategy on Lowering Blood Lipid Levels in Indian Physicians
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lifestyle Risk Reduction
Cholesterol, Elevated
LDL Hyperlipoproteinemia
Hypertension
Lipoprotein(A)
HbA1C
BMI
Keywords: Intermittend fasting
Blood lipid level lowering
Lead sponsor: Jubilee Mission Medical College and Research Institute
Sponsor class: OTHER
Collaborators: name: Christian Medical College, Vellore, India
First posted: 2024-05-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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

Eligibility criteria: Inclusion Criteria: All willing Indian doctors 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

Primary outcomes:
measure: Changes in the blood lipid levels
timeFrame: 4 weeks
Secondary outcomes:
measure: Changes in the anthropometric and biochemical parameters
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Thrissur
country: India
facility: Manoj Varanattu
state: Kerala
Study officials:
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