Lifestyle Risk ReductionCLIPNCT06420817
Effect of a Customised Lifestyle Medicine Strategy on Lowering Blood Lipid Levels in Indian Physicians
A study testing Indian version of a 'Portfolio' diet, Physical Activity and Intermittent fasting in people with Lifestyle Risk Reduction and Cholesterol, Elevated, run by Jubilee Mission Medical College and Research Institute at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Lifestyle Risk Reduction, Cholesterol, Elevated, LDL Hyperlipoproteinemia
- What is being tested?
- Indian version of a 'Portfolio' diet, Physical Activity and Intermittent fasting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- 15 Feb 2024to 15 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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:
- 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.
- Proportion of participants achieving reduction in BMI \& Waist to Hip Ratio
- Proportion of hypertensive participants achieving reduction in BP
- Proportion of DM participants achieving reduction in HbA1C
- Proportion of participants achieving reduction in TC \& LDL levels
- Proportion of participants achieving reduction in all the other biochemical parameters studied
- Conditions
- Lifestyle Risk Reduction, Cholesterol, Elevated, LDL Hyperlipoproteinemia, Hypertension, Lipoprotein(A), HbA1C
- Being tested
- Indian version of a 'Portfolio' diet, Physical Activity, Intermittent fasting, Monitoring of sleep and stress levels
- Keywords
- Intermittend fasting, Blood lipid level lowering
- Medical subject headings
- Risk Reduction Behavior, Hypercholesterolemia, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indian version of a 'Portfolio' dietBehavioural
Also called Indian version of a dietary portfolio of cholesterol lowering foods
The participants will be required to follow the prescribed diet plan for 4 weeks
Physical ActivityBehavioural
Also called Exercise, Workout
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 fastingBehavioural
Also called Time Restricted Eating
The participants will be required to do intermittent fasting for 12 hours daily for 4 weeks
Monitoring of sleep and stress levelsBehavioural
The participants will be required to monitor their sleep and stress levels
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle Interventions | Experimental | 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 Receives: Behavioral: Indian version of a 'Portfolio' diet; Behavioral: Physical Activity; Behavioral: Intermittent fasting; Behavioral: Monitoring of sleep and stress levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks
Secondary outcomes (1)
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
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start15 Feb 2024
- Primary completion31 May 2024 (estimated)
- Study completion15 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for Lifestyle Risk ReductionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- 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
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jubilee Mission Medical College and Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Christian Medical College, Vellore, India
- Responsible party
- Principal investigator, Dr. Manoj Varanattu, Jubilee Mission Medical College and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06420817
- Sponsor's protocol ID
- CLIP
- Acronym
- CLIP
- Status last verified
- May 2024
- First submitted
- 15 May 2024
- Last updated
- 20 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jenkins DJ, Kendall CW, Marchie A, Faulkner DA, Wong JM, de Souza R, Emam A, Parker TL, Vidgen E, Trautwein EA, Lapsley KG, Josse RG, Leiter LA, Singer W, Connelly PW. Direct comparison of a dietary portfolio of cholesterol-lowering foods with a statin in hypercholesterolemic participants. Am J Clin Nutr. 2005 Feb;81(2):380-7. doi: 10.1093/ajcn.81.2.380.
PubMed 15699225Khodamoradi K, Khosropanah MH, Ayati Z, Chang D, Nasli-Esfahani E, Ayati MH, Namazi N. The Effects of Fenugreek on Cardiometabolic Risk Factors in Adults: A Systematic Review and Meta-analysis. Complement Ther Med. 2020 Aug;52:102416. doi: 10.1016/j.ctim.2020.102416. Epub 2020 Apr 28.
PubMed 32951700Heshmat-Ghahdarijani K, Mashayekhiasl N, Amerizadeh A, Teimouri Jervekani Z, Sadeghi M. Effect of fenugreek consumption on serum lipid profile: A systematic review and meta-analysis. Phytother Res. 2020 Sep;34(9):2230-2245. doi: 10.1002/ptr.6690. Epub 2020 May 8.
PubMed 32385866Gopa B, Bhatt J, Hemavathi KG. A comparative clinical study of hypolipidemic efficacy of Amla (Emblica officinalis) with 3-hydroxy-3-methylglutaryl-coenzyme-A reductase inhibitor simvastatin. Indian J Pharmacol. 2012 Mar;44(2):238-42. doi: 10.4103/0253-7613.93857.
PubMed 22529483Akhtar MS, Ramzan A, Ali A, Ahmad M. Effect of Amla fruit (Emblica officinalis Gaertn.) on blood glucose and lipid profile of normal subjects and type 2 diabetic patients. Int J Food Sci Nutr. 2011 Sep;62(6):609-16. doi: 10.3109/09637486.2011.560565. Epub 2011 Apr 18.
PubMed 21495900Uma Maheswari K, Dilara K, Vadivel S, Johnson P, Jayaraman S. A review on hypo-cholesterolemic activity of Nigella sativa seeds and its extracts. Bioinformation. 2022 Apr 30;18(4):343-348. doi: 10.6026/97320630018343. eCollection 2022.
PubMed 36909699Hallajzadeh J, Milajerdi A, Mobini M, Amirani E, Azizi S, Nikkhah E, Bahadori B, Sheikhsoleimani R, Mirhashemi SM. Effects of Nigella sativa on glycemic control, lipid profiles, and biomarkers of inflammatory and oxidative stress: A systematic review and meta-analysis of randomized controlled clinical trials. Phytother Res. 2020 Oct;34(10):2586-2608. doi: 10.1002/ptr.6708. Epub 2020 May 11.
PubMed 32394508Sahebkar A, Beccuti G, Simental-Mendia LE, Nobili V, Bo S. Nigella sativa (black seed) effects on plasma lipid concentrations in humans: A systematic review and meta-analysis of randomized placebo-controlled trials. Pharmacol Res. 2016 Apr;106:37-50. doi: 10.1016/j.phrs.2016.02.008. Epub 2016 Feb 10.
PubMed 26875640Prasad K, Khan AS, Shoker M. Flaxseed and Its Components in Treatment of Hyperlipidemia and Cardiovascular Disease. Int J Angiol. 2020 Dec;29(4):216-222. doi: 10.1055/s-0040-1709129. Epub 2020 Apr 14.
PubMed 33268971Sadat Masjedi M, Mohammadi Pour P, Shokoohinia Y, Asgary S. Effects of Flaxseed on Blood Lipids in Healthy and Dyslipidemic Subjects: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Curr Probl Cardiol. 2022 Jul;47(7):100931. doi: 10.1016/j.cpcardiol.2021.100931. Epub 2021 Jul 16.
PubMed 34384619Amiri M, Raeisi-Dehkordi H, Sarrafzadegan N, Forbes SC, Salehi-Abargouei A. The effects of Canola oil on cardiovascular risk factors: A systematic review and meta-analysis with dose-response analysis of controlled clinical trials. Nutr Metab Cardiovasc Dis. 2020 Nov 27;30(12):2133-2145. doi: 10.1016/j.numecd.2020.06.007. Epub 2020 Jun 18.
PubMed 33127255Schwingshackl L, Bogensberger B, Bencic A, Knuppel S, Boeing H, Hoffmann G. Effects of oils and solid fats on blood lipids: a systematic review and network meta-analysis. J Lipid Res. 2018 Sep;59(9):1771-1782. doi: 10.1194/jlr.P085522. Epub 2018 Jul 13.
PubMed 30006369Wilson TA, Ausman LM, Lawton CW, Hegsted DM, Nicolosi RJ. Comparative cholesterol lowering properties of vegetable oils: beyond fatty acids. J Am Coll Nutr. 2000 Oct;19(5):601-7. doi: 10.1080/07315724.2000.10718957.
PubMed 11022873Saedi S, Noroozi M, Khosrotabar N, Mazandarani S, Ghadrdoost B. How canola and sunflower oils affect lipid profile and anthropometric parameters of participants with dyslipidemia. Med J Islam Repub Iran. 2017 Jan 15;31:5. doi: 10.18869/mjiri.31.5. eCollection 2017.
PubMed 28638812Craig WJ, Mangels AR, Fresan U, Marsh K, Miles FL, Saunders AV, Haddad EH, Heskey CE, Johnston P, Larson-Meyer E, Orlich M. The Safe and Effective Use of Plant-Based Diets with Guidelines for Health Professionals. Nutrients. 2021 Nov 19;13(11):4144. doi: 10.3390/nu13114144.
PubMed 34836399
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Customised Lifestyle Medicine Strategy on Lowering Blood Lipid Levels in Indian Physicians
- ClinicalTrials.gov ID
- NCT06420817
- Acronym / sponsor ID
- CLIP / CLIP
- Conditions
- Lifestyle Risk Reduction, Cholesterol, Elevated, LDL Hyperlipoproteinemia, Hypertension, Lipoprotein(A), HbA1C
- Keywords
- Intermittend fasting, Blood lipid level lowering
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Jubilee Mission Medical College and Research InstituteUniversity, hospital or other
- Collaborators
- Christian Medical College, Vellore, India
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 15 Aug 2024 (estimated)
- First posted
- 20 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- Proportion of participants achieving reduction in BMI \& Waist to Hip Ratio
- Proportion of hypertensive participants achieving reduction in BP
- Proportion of DM participants achieving reduction in HbA1C
- Proportion of participants achieving reduction in TC \& LDL levels
- Proportion of participants achieving reduction in all the other biochemical parameters studied
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| Lifestyle Interventions | Experimental | Behavioral: Indian version of a 'Portfolio' diet, Behavioral: Physical Activity, Behavioral: Intermittent fasting, Behavioral: Monitoring of sleep and stress levelsLifestyle 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indian version of a 'Portfolio' dietAlso: Indian version of a dietary portfolio of cholesterol lowering foodsThe participants will be required to follow the prescribed diet plan for 4 weeks | Behavioural | Lifestyle Interventions |
| Physical ActivityAlso: Exercise, WorkoutThe 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) | Behavioural | Lifestyle Interventions |
| Intermittent fastingAlso: Time Restricted EatingThe participants will be required to do intermittent fasting for 12 hours daily for 4 weeks | Behavioural | Lifestyle Interventions |
| Monitoring of sleep and stress levelsThe participants will be required to monitor their sleep and stress levels | Behavioural | Lifestyle Interventions |
Primary outcome
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
1 secondary outcome
Changes in the anthropometric and biochemical parameters
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
- Background: PubMed 15699225Jenkins DJ, Kendall CW, Marchie A, Faulkner DA, Wong JM, de Souza R, Emam A, Parker TL, Vidgen E, Trautwein EA, Lapsley KG, Josse RG, Leiter LA, Singer W, Connelly PW. Direct comparison of a dietary portfolio of cholesterol-lowering foods with a statin in hypercholesterolemic participants. Am J Clin Nutr. 2005 Feb;81(2):380-7. doi: 10.1093/ajcn.81.2.380.
- Background: PubMed 32951700Khodamoradi K, Khosropanah MH, Ayati Z, Chang D, Nasli-Esfahani E, Ayati MH, Namazi N. The Effects of Fenugreek on Cardiometabolic Risk Factors in Adults: A Systematic Review and Meta-analysis. Complement Ther Med. 2020 Aug;52:102416. doi: 10.1016/j.ctim.2020.102416. Epub 2020 Apr 28.
- Background: PubMed 32385866Heshmat-Ghahdarijani K, Mashayekhiasl N, Amerizadeh A, Teimouri Jervekani Z, Sadeghi M. Effect of fenugreek consumption on serum lipid profile: A systematic review and meta-analysis. Phytother Res. 2020 Sep;34(9):2230-2245. doi: 10.1002/ptr.6690. Epub 2020 May 8.
- Background: PubMed 22529483Gopa B, Bhatt J, Hemavathi KG. A comparative clinical study of hypolipidemic efficacy of Amla (Emblica officinalis) with 3-hydroxy-3-methylglutaryl-coenzyme-A reductase inhibitor simvastatin. Indian J Pharmacol. 2012 Mar;44(2):238-42. doi: 10.4103/0253-7613.93857.
- Background: PubMed 21495900Akhtar MS, Ramzan A, Ali A, Ahmad M. Effect of Amla fruit (Emblica officinalis Gaertn.) on blood glucose and lipid profile of normal subjects and type 2 diabetic patients. Int J Food Sci Nutr. 2011 Sep;62(6):609-16. doi: 10.3109/09637486.2011.560565. Epub 2011 Apr 18.
- Background: PubMed 36909699Uma Maheswari K, Dilara K, Vadivel S, Johnson P, Jayaraman S. A review on hypo-cholesterolemic activity of Nigella sativa seeds and its extracts. Bioinformation. 2022 Apr 30;18(4):343-348. doi: 10.6026/97320630018343. eCollection 2022.
- Background: PubMed 32394508Hallajzadeh J, Milajerdi A, Mobini M, Amirani E, Azizi S, Nikkhah E, Bahadori B, Sheikhsoleimani R, Mirhashemi SM. Effects of Nigella sativa on glycemic control, lipid profiles, and biomarkers of inflammatory and oxidative stress: A systematic review and meta-analysis of randomized controlled clinical trials. Phytother Res. 2020 Oct;34(10):2586-2608. doi: 10.1002/ptr.6708. Epub 2020 May 11.
- Background: PubMed 26875640Sahebkar A, Beccuti G, Simental-Mendia LE, Nobili V, Bo S. Nigella sativa (black seed) effects on plasma lipid concentrations in humans: A systematic review and meta-analysis of randomized placebo-controlled trials. Pharmacol Res. 2016 Apr;106:37-50. doi: 10.1016/j.phrs.2016.02.008. Epub 2016 Feb 10.
- Background: PubMed 33268971Prasad K, Khan AS, Shoker M. Flaxseed and Its Components in Treatment of Hyperlipidemia and Cardiovascular Disease. Int J Angiol. 2020 Dec;29(4):216-222. doi: 10.1055/s-0040-1709129. Epub 2020 Apr 14.
- Background: PubMed 34384619Sadat Masjedi M, Mohammadi Pour P, Shokoohinia Y, Asgary S. Effects of Flaxseed on Blood Lipids in Healthy and Dyslipidemic Subjects: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Curr Probl Cardiol. 2022 Jul;47(7):100931. doi: 10.1016/j.cpcardiol.2021.100931. Epub 2021 Jul 16.
- Background: PubMed 33127255Amiri M, Raeisi-Dehkordi H, Sarrafzadegan N, Forbes SC, Salehi-Abargouei A. The effects of Canola oil on cardiovascular risk factors: A systematic review and meta-analysis with dose-response analysis of controlled clinical trials. Nutr Metab Cardiovasc Dis. 2020 Nov 27;30(12):2133-2145. doi: 10.1016/j.numecd.2020.06.007. Epub 2020 Jun 18.
- Background: PubMed 30006369Schwingshackl L, Bogensberger B, Bencic A, Knuppel S, Boeing H, Hoffmann G. Effects of oils and solid fats on blood lipids: a systematic review and network meta-analysis. J Lipid Res. 2018 Sep;59(9):1771-1782. doi: 10.1194/jlr.P085522. Epub 2018 Jul 13.
Related trials for Lifestyle Risk Reduction
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Culinary And Lifestyle Medicine Education for Cancer Risk Reduction in Survivors of Breast Cancer
Breast Cancer
Active, not recruitingPhase 2
Phase IIB Trial of Bazedoxifene Plus Conjugated Estrogens
Risk Reduction, Breast Cancer
Recruiting
SMART GOALS for Youth With Prediabetes
PreDiabetes, Adolescent Obesity
RecruitingObservational study
Breast Cancer Risk Assessment in Night Shift Workers - Implementation of a Personalized Consultation
Breast Neoplasms Diagnosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indian version of a 'Portfolio' diet, Physical Activity and Intermittent fasting in people with Lifestyle Risk Reduction and Cholesterol, Elevated, run by Jubilee Mission Medical College and Research Institute at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the blood lipid levels (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06420817, which also lists 38 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2024.