Effect of a Customised Lifestyle Medicine Strategy on Lowering Blood Lipid Levels in Indian Physicians (CLIP)

May 15, 2024 updated by: Dr. Manoj Varanattu, Jubilee Mission Medical College and Research Institute
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Kerala
      • Thrissur, Kerala, India, 680005
        • Manoj Varanattu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Behavioral: Indian version of a 'Portfolio' diet
The participants will be required to follow the prescribed diet plan for 4 weeks
Other Names:
  • Indian version of a dietary portfolio of cholesterol lowering foods
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)

Other Names:
  • Exercise
  • Workout
Behavioral: Intermittent fasting
The participants will be required to do intermittent fasting for 12 hours daily for 4 weeks
Other Names:
  • Time Restricted Eating
Behavioral: Monitoring of sleep and stress levels
The participants will be required to monitor their sleep and stress levels

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the blood lipid levels
Time Frame: 4 weeks
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
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the anthropometric and biochemical parameters
Time Frame: 4 weeks
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
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jubilee Mission Medical College and Research Institute

Collaborators

Christian Medical College, Vellore, India

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2024

Primary Completion (Estimated)

May 31, 2024

Study Completion (Estimated)

August 15, 2024

Study Registration Dates

First Submitted

May 15, 2024

First Submitted That Met QC Criteria

May 15, 2024

First Posted (Actual)

May 20, 2024

Study Record Updates

Last Update Posted (Actual)

May 20, 2024

Last Update Submitted That Met QC Criteria

May 15, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLIP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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