OverweightTEFNCT02939638

Diet, Insulin Sensitivity, and Postprandial Metabolism

A study testing Plant-based diet in people with Overweight and Obesity, run by Physicians Committee for Responsible Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This randomized, controlled trial aims to elucidate the mechanisms by which a plant-based dietary intervention causes weight loss. Using a low-fat, plant-based diet for 16 weeks, along with an untreated control for comparison, the study will measure changes in body weight, body composition, intramyocellular and/or… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Overweight, Obesity, Insulin Resistance
What is being tested?: Plant-based diet
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 220 participants
Where: 1 siteUnited States
Study dates: Oct 2016to 9 Jan 2019
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Men and women age ≥18 years of age
Body mass index 28-40 kg/m2

Who cannot join

Diabetes mellitus, type 1 or 2, history of diabetes mellitus or of any endocrine condition that would affect body weight, such as thyroid disease, pituitary abnormality, or Cushing's syndrome
Smoking during the past six months
Alcohol consumption of more than 2 drinks per day or the equivalent, episodic increased drinking (e.g., more than 2 drinks per day on weekends), or a history of alcohol abuse or dependency followed by any current use
Use of recreational drugs in the past 6 months
Use within the preceding six months of medications that affect appetite or body weight, such as estrogens or other hormones, thyroid medications, systemic steroids, antidepressants (tricyclics, monoamine oxidase inhibitors (MAOIs), selective serotonin reuptake inhibitors (SSRIs), antipsychotics, lithium, anticonvulsants, appetite suppressants or other weight-loss drugs, herbs for weight loss or mood, St. John's wort, ephedra, beta blockers
Pregnancy or intention to become pregnant during the study period

Show all 14Show fewer

Unstable medical or psychiatric illness
Evidence of an eating disorder
Likely to be disruptive in group sessions
Already following a low-fat, vegan diet
Lack of English fluency
Inability to maintain current medication regimen
Inability or unwillingness to participate in all components of the study
Intention to follow another weight-loss method during the trial

Trial locations and contacts

1 site in 1 country.

United States1 site

Physicians Committee for Responsible Medicine
Washington D.C., District of Columbia, 20016

Other trials in United States

About this study

Official title: A Randomized, Controlled Trial on Diet, Insulin Sensitivity, and Postprandial Metabolism

Read the detailed description

In a 16-week trial, overweight adults will be randomly assigned to two groups. Changes in body weight, body composition, intramyocellular and/or intrahepatocellular lipid, and changes in association to body weight will be measured among other outcomes.

The Intervention Group will follow a low-fat, vegan diet and will receive weekly classes and support.

The Control Group will be asked to follow a conventional control diet.

This study conducts a pilot sub-study to test the hypothesis that changes in insulin sensitivity and beta-cell function observed in response to a diet intervention correlate with changes in intramyocellular and/or intrahepatocellular lipid. Another sub-study assesses the association between metabolic outcomes and gut microbiome. One additional sub-study is looking for associations between metabolic outcomes and endothelial function.

Conditions: Overweight, Obesity, Insulin Resistance
Being tested: Plant-based diet, Control Diet
Keywords: Plant-based diet, Obesity, Insulin sensitivity, Intracellular lipid, Postprandial metabolism, Vegan diet, Beta-cell function
Medical subject headings: Overweight, Obesity, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Plant-based dietOther
Also called Vegan diet
Weekly instructions will be given to the participants in the intervention group about following vegan diet.
Control DietOther
Participants will be asked to continue their usual diets for the 16-week study period.

Study groups in NCT02939638
Study group	Role	What they receive
Plant-based diet	Active comparator	The diet group will be asked to follow a low-fat, vegan diet for 16 weeks Receives: Other: Plant-based diet
Control diet	Active comparator	Half of the participants will be asked to continue their usual diets for the 16-week study period. Receives: Other: Control Diet

What is being measured

The primary outcome is the main question the study is designed to answer.

Body weight in kg
Anticipated weight-loss for intervention group compared with control group. Weight and height will be combined to report BMI in kg/m^2
Measured: 16 weeks
Fat mass in grams
Anticipated weight-loss for intervention group compared with control group.
Measured: 16 weeks
Visceral fat in cm^3
Anticipated weight-loss for intervention group compared with control group.
Measured: 16 weeks
Changes in intramyocellular and/or intrahepatocellular lipid
A subset of participants will be selected for magnetic resonance (MR) spectroscopy studies quantifying hepatic lipid and/or intramyocellular and/or contents in order to provide data regarding possible causal relationships between dietary changes, ectopic lipid, and insulin sensitivity. Selected individuals with varying degrees of insulin-resistance in both groups will be assessed before and after the intervention period. These magnetic resonance spectroscopy (MRS) studies will take place at the Magnetic Research Center at Yale University School of Medicine, New Haven, CT.
Measured: 16 Weeks
Insulin resistance
Insulin resistance will be assessed by the Homeostatic Model Assessment (HOMA) index.
Measured: 16 weeks
Resting Energy Expenditure (REE)
Participants will be asked to report to the laboratory within 60 minutes of waking and after a 12-hour fast. Following 30 minutes of quiet rest in a dimly lit room, pulse, respiratory rate, and body temperature will be measured. REE will be measured for 20 minutes through indirect calorimetry (COSMED Metabolic Company Quark Resting Metabolic Rate (RMR), Chicago, IL) utilizing a ventilated hood system. The laboratory temperature will be maintained at 23 degrees C throughout, and precautions will be taken to minimize any disturbances that could affect the metabolic rate. For premenopausal women, measures will be timed so as to occur in the luteal phase of the menstrual cycle.
Measured: 16 weeks
Postprandial metabolism
Participants will be asked to report to the laboratory within 60 minutes of waking and after a 12-hour fast. Postprandial metabolism will be measured for three hours after the standard meal. For premenopausal women, measures will be timed so as to occur in the luteal phase of the menstrual cycle.
Measured: 16 weeks

Secondary outcomes (15)

Beta-cell function as measured by glucose (mmmol/L)
A standard meal test will be performed after an overnight fast. Plasma glucose, will be measured at 0, 30, 60, 120, and 180 min for a total of 3-hours over a 16-week period. Glucose, insulin and C-peptide will combined and analyzed to report Beta-cell function.
Measured: 16 weeks
Beta-cell function as measured by insulin (pmol/L)
A standard meal test will be performed after an overnight fast. Plasma insulin will be measured at 0, 30, 60, 120, and 180 min for a total of 3-hours over a 16-week period. Glucose, insulin and C-peptide will combined and analyzed to report Beta-cell function.
Measured: 16 weeks
Beta-cell function as measured by C-peptide (ng/mL)
A standard meal test will be performed after an overnight fast. Plasma C-peptide will be measured at 0, 30, 60, 120, and 180 min for a total of 3-hours over a 16-week period. Glucose, insulin and C-peptide will combined and analyzed to report Beta-cell function.
Measured: 16 weeks
Microbiome Analysis
Microbiome analysis from participant-provided stool sample. Analysis from uBiome Biotechnology company in a subset of participants. Anticipated changes in the dietary intervention group include changes in the microbiome composition that correlate with changes in insulin sensitivity.
Measured: 16 weeks
Endothelial function
Endothelial function will be measured using the EndoPAT, a proprietary diagnostic device for functional vascular health assessment, in a subset of participants.
Measured: 16 weeks
Diet Assessment Recall Questionnaire
24-hour multi-pass dietary recalls will be used to assess dietary adherence to assist study personnel in working with individuals who need additional teaching or support.
Measured: 16 weeks
The Effect of Fat Quantity & Quality on Body Composition, Insulin Resistance, & Insulin Secretion
Regression Analysis will be used to assess The Effect of Fat Quantity \& Quality on Body Composition, Insulin Resistance, \& Insulin Secretion
Measured: 16 Weeks
The Effect of Carbohydrate Quantity & Quality on Body Composition & Insulin Resistance
Regression Analysis will be used to assess The Effect of Carbohydrate Quantity \& Quality on Body Composition \& Insulin Resistance
Measured: 16 Weeks
The Effect of Protein Quantity & Quality on Body Composition, Insulin Resistance, & Insulin Secretion
Regression Analysis will be used to assess The Effect of Protein Quantity \& Quality on Body Composition, Insulin Resistance, \& Insulin Secretion
Measured: 16 Weeks
Levels of Advanced Glycosylation Endproducts (AGEs)
An AGE reader will be used to measure the Levels of the AGEs in the skin
Measured: 16 Weeks
Race Disparities
Compare the effectiveness of the vegan diet in Blacks vs. Whites in all the primary outcomes
Measured: 16 weeks
Dietary Advanced Glycation End Products (AGEs)
Explore the effectiveness of a vegan diet in reducing dietary AGEs.
Measured: 16 weeks
Food costs
Food costs will be assessed, using the U.S. Department of Agriculture Thrifty Food Plan, 2021, at baseline and 16 weeks.
Measured: 16 weeks
PDI, hPDI, uPDI
Assess the total plant-based index (PDI), healthy PDI, and unhealthy PDI, and their relationship with weight loss
Measured: 16 weeks
Ultraprocessed foods
The consumption of ultraprocessed foods will be assessed, using the NOVA classification, at baseline and 16 weeks.
Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 20169 Jan 2019

First posted20 Oct 2016 (estimated)
Study startOct 2016
Primary completionDec 2018
Study completion9 Jan 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (20)Papers the sponsor has linked to this study.
Other trials for OverweightStudies 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 220 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02939638
Sponsor's protocol ID: Pro00018983
Acronym: TEF
Status last verified: Jul 2023
First submitted: 17 Oct 2016
Last updated: 19 Jul 2023
Results posted: No
Data monitoring committee: Yes
Individual data sharing: Undecided

Publications

Tonstad S, Butler T, Yan R, Fraser GE. Type of vegetarian diet, body weight, and prevalence of type 2 diabetes. Diabetes Care. 2009 May;32(5):791-6. doi: 10.2337/dc08-1886. Epub 2009 Apr 7.
PubMed 19351712
Barnard ND, Levin SM, Yokoyama Y. A systematic review and meta-analysis of changes in body weight in clinical trials of vegetarian diets. J Acad Nutr Diet. 2015 Jun;115(6):954-69. doi: 10.1016/j.jand.2014.11.016. Epub 2015 Jan 22.
PubMed 25620754
Barnard ND, Scialli AR, Turner-McGrievy G, Lanou AJ, Glass J. The effects of a low-fat, plant-based dietary intervention on body weight, metabolism, and insulin sensitivity. Am J Med. 2005 Sep;118(9):991-7. doi: 10.1016/j.amjmed.2005.03.039.
PubMed 16164885
Shulman GI. Ectopic fat in insulin resistance, dyslipidemia, and cardiometabolic disease. N Engl J Med. 2014 Sep 18;371(12):1131-41. doi: 10.1056/NEJMra1011035. No abstract available.
PubMed 25229917
Petersen KF, Dufour S, Morino K, Yoo PS, Cline GW, Shulman GI. Reversal of muscle insulin resistance by weight reduction in young, lean, insulin-resistant offspring of parents with type 2 diabetes. Proc Natl Acad Sci U S A. 2012 May 22;109(21):8236-40. doi: 10.1073/pnas.1205675109. Epub 2012 Apr 30.
PubMed 22547801
Sparks LM, Xie H, Koza RA, Mynatt R, Hulver MW, Bray GA, Smith SR. A high-fat diet coordinately downregulates genes required for mitochondrial oxidative phosphorylation in skeletal muscle. Diabetes. 2005 Jul;54(7):1926-33. doi: 10.2337/diabetes.54.7.1926.
PubMed 15983191
Goff LM, Bell JD, So PW, Dornhorst A, Frost GS. Veganism and its relationship with insulin resistance and intramyocellular lipid. Eur J Clin Nutr. 2005 Feb;59(2):291-8. doi: 10.1038/sj.ejcn.1602076.
PubMed 15523486
Barnard ND, Gloede L, Cohen J, Jenkins DJ, Turner-McGrievy G, Green AA, Ferdowsian H. A low-fat vegan diet elicits greater macronutrient changes, but is comparable in adherence and acceptability, compared with a more conventional diabetes diet among individuals with type 2 diabetes. J Am Diet Assoc. 2009 Feb;109(2):263-72. doi: 10.1016/j.jada.2008.10.049.
PubMed 19167953
Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
PubMed 12900694
Petersen KF, Dufour S, Feng J, Befroy D, Dziura J, Dalla Man C, Cobelli C, Shulman GI. Increased prevalence of insulin resistance and nonalcoholic fatty liver disease in Asian-Indian men. Proc Natl Acad Sci U S A. 2006 Nov 28;103(48):18273-7. doi: 10.1073/pnas.0608537103. Epub 2006 Nov 17.
PubMed 17114290
Gruetter R. Automatic, localized in vivo adjustment of all first- and second-order shim coils. Magn Reson Med. 1993 Jun;29(6):804-11. doi: 10.1002/mrm.1910290613.
PubMed 8350724
Rabol R, Petersen KF, Dufour S, Flannery C, Shulman GI. Reversal of muscle insulin resistance with exercise reduces postprandial hepatic de novo lipogenesis in insulin resistant individuals. Proc Natl Acad Sci U S A. 2011 Aug 16;108(33):13705-9. doi: 10.1073/pnas.1110105108. Epub 2011 Aug 1.
PubMed 21808028
American Dietetic Association; Dietitians of Canada. Position of the American Dietetic Association and Dietitians of Canada: Vegetarian diets. J Am Diet Assoc. 2003 Jun;103(6):748-65. doi: 10.1053/jada.2003.50142.
PubMed 12778049
Barnard ND, Akhtar A, Nicholson A. Factors that facilitate compliance to lower fat intake. Arch Fam Med. 1995 Feb;4(2):153-8. doi: 10.1001/archfami.4.2.153.
PubMed 7842153
Buzzard IM, Faucett CL, Jeffery RW, McBane L, McGovern P, Baxter JS, Shapiro AC, Blackburn GL, Chlebowski RT, Elashoff RM, Wynder EL. Monitoring dietary change in a low-fat diet intervention study: advantages of using 24-hour dietary recalls vs food records. J Am Diet Assoc. 1996 Jun;96(6):574-9. doi: 10.1016/S0002-8223(96)00158-7.
PubMed 8655904

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Controlled Trial on Diet, Insulin Sensitivity, and Postprandial Metabolism
ClinicalTrials.gov ID: NCT02939638
Acronym / sponsor ID: TEF / Pro00018983
Conditions: Overweight, Obesity, Insulin Resistance
Keywords: Plant-based diet, Obesity, Insulin sensitivity, Intracellular lipid, Postprandial metabolism, Vegan diet, Beta-cell function
Study type: Interventional
Recruitment status: Completed
Enrolment: 220 participants (actual)
Lead sponsor: Physicians Committee for Responsible MedicineUniversity, hospital or other
Collaborators: Yale University
Study start: Oct 2016 (actual)
Primary completion: Dec 2018 (actual)
Study completion: 9 Jan 2019 (actual)
First posted: 20 Oct 2016 (estimated)
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.

Detailed description

The Intervention Group will follow a low-fat, vegan diet and will receive weekly classes and support.

The Control Group will be asked to follow a conventional control diet.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Plant-based diet	Active comparator	Other: Plant-based dietThe diet group will be asked to follow a low-fat, vegan diet for 16 weeks
Control diet	Active comparator	Other: Control DietHalf of the participants will be asked to continue their usual diets for the 16-week study period.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Men and women age ≥18 years of age
Body mass index 28-40 kg/m2

Key exclusion criteria (14 listed)

Diabetes mellitus, type 1 or 2, history of diabetes mellitus or of any endocrine condition that would affect body weight, such as thyroid disease, pituitary abnormality, or Cushing's syndrome
Smoking during the past six months
Alcohol consumption of more than 2 drinks per day or the equivalent, episodic increased drinking (e.g., more than 2 drinks per day on weekends), or a history of alcohol abuse or dependency followed by any current use
Use of recreational drugs in the past 6 months
Use within the preceding six months of medications that affect appetite or body weight, such as estrogens or other hormones, thyroid medications, systemic steroids, antidepressants (tricyclics, monoamine oxidase inhibitors (MAOIs), selective serotonin reuptake inhibitors (SSRIs), antipsychotics, lithium, anticonvulsants, appetite suppressants or other weight-loss drugs, herbs for weight loss or mood, St. John's wort, ephedra, beta blockers

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
Plant-based dietAlso: Vegan dietWeekly instructions will be given to the participants in the intervention group about following vegan diet.	Other	Plant-based diet
Control DietParticipants will be asked to continue their usual diets for the 16-week study period.	Other	Control diet

Primary outcome

Body weight in kg
Time frame: 16 weeks
Anticipated weight-loss for intervention group compared with control group. Weight and height will be combined to report BMI in kg/m^2
Fat mass in grams
Time frame: 16 weeks
Anticipated weight-loss for intervention group compared with control group.
Visceral fat in cm^3
Time frame: 16 weeks
Anticipated weight-loss for intervention group compared with control group.
Changes in intramyocellular and/or intrahepatocellular lipid
Time frame: 16 Weeks
A subset of participants will be selected for magnetic resonance (MR) spectroscopy studies quantifying hepatic lipid and/or intramyocellular and/or contents in order to provide data regarding possible causal relationships between dietary changes, ectopic lipid, and insulin sensitivity. Selected individuals with varying degrees of insulin-resistance in both groups will be assessed before and after the intervention period. These magnetic resonance spectroscopy (MRS) studies will take place at the Magnetic Research Center at Yale University School of Medicine, New Haven, CT.
Insulin resistance
Time frame: 16 weeks
Insulin resistance will be assessed by the Homeostatic Model Assessment (HOMA) index.
Resting Energy Expenditure (REE)
Time frame: 16 weeks
Participants will be asked to report to the laboratory within 60 minutes of waking and after a 12-hour fast. Following 30 minutes of quiet rest in a dimly lit room, pulse, respiratory rate, and body temperature will be measured. REE will be measured for 20 minutes through indirect calorimetry (COSMED Metabolic Company Quark Resting Metabolic Rate (RMR), Chicago, IL) utilizing a ventilated hood system. The laboratory temperature will be maintained at 23 degrees C throughout, and precautions will be taken to minimize any disturbances that could affect the metabolic rate. For premenopausal women, measures will be timed so as to occur in the luteal phase of the menstrual cycle.
Postprandial metabolism
Time frame: 16 weeks
Participants will be asked to report to the laboratory within 60 minutes of waking and after a 12-hour fast. Postprandial metabolism will be measured for three hours after the standard meal. For premenopausal women, measures will be timed so as to occur in the luteal phase of the menstrual cycle.

15 secondary outcomes

Beta-cell function as measured by glucose (mmmol/L)
Time frame: 16 weeks
Beta-cell function as measured by insulin (pmol/L)
Time frame: 16 weeks
Beta-cell function as measured by C-peptide (ng/mL)
Time frame: 16 weeks
Microbiome Analysis
Time frame: 16 weeks
Endothelial function
Time frame: 16 weeks
Diet Assessment Recall Questionnaire
Time frame: 16 weeks
The Effect of Fat Quantity & Quality on Body Composition, Insulin Resistance, & Insulin Secretion
Time frame: 16 Weeks
The Effect of Carbohydrate Quantity & Quality on Body Composition & Insulin Resistance
Time frame: 16 Weeks
The Effect of Protein Quantity & Quality on Body Composition, Insulin Resistance, & Insulin Secretion
Time frame: 16 Weeks
Levels of Advanced Glycosylation Endproducts (AGEs)
Time frame: 16 Weeks
Race Disparities
Time frame: 16 weeks
Dietary Advanced Glycation End Products (AGEs)
Time frame: 16 weeks
Food costs
Time frame: 16 weeks
PDI, hPDI, uPDI
Time frame: 16 weeks
Ultraprocessed foods
Time frame: 16 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
Background: PubMed 19351712Tonstad S, Butler T, Yan R, Fraser GE. Type of vegetarian diet, body weight, and prevalence of type 2 diabetes. Diabetes Care. 2009 May;32(5):791-6. doi: 10.2337/dc08-1886. Epub 2009 Apr 7.
Background: PubMed 25620754Barnard ND, Levin SM, Yokoyama Y. A systematic review and meta-analysis of changes in body weight in clinical trials of vegetarian diets. J Acad Nutr Diet. 2015 Jun;115(6):954-69. doi: 10.1016/j.jand.2014.11.016. Epub 2015 Jan 22.
Background: PubMed 16164885Barnard ND, Scialli AR, Turner-McGrievy G, Lanou AJ, Glass J. The effects of a low-fat, plant-based dietary intervention on body weight, metabolism, and insulin sensitivity. Am J Med. 2005 Sep;118(9):991-7. doi: 10.1016/j.amjmed.2005.03.039.
Background: PubMed 25229917Shulman GI. Ectopic fat in insulin resistance, dyslipidemia, and cardiometabolic disease. N Engl J Med. 2014 Sep 18;371(12):1131-41. doi: 10.1056/NEJMra1011035. No abstract available.
Background: PubMed 22547801Petersen KF, Dufour S, Morino K, Yoo PS, Cline GW, Shulman GI. Reversal of muscle insulin resistance by weight reduction in young, lean, insulin-resistant offspring of parents with type 2 diabetes. Proc Natl Acad Sci U S A. 2012 May 22;109(21):8236-40. doi: 10.1073/pnas.1205675109. Epub 2012 Apr 30.
Background: PubMed 15983191Sparks LM, Xie H, Koza RA, Mynatt R, Hulver MW, Bray GA, Smith SR. A high-fat diet coordinately downregulates genes required for mitochondrial oxidative phosphorylation in skeletal muscle. Diabetes. 2005 Jul;54(7):1926-33. doi: 10.2337/diabetes.54.7.1926.
Background: PubMed 15523486Goff LM, Bell JD, So PW, Dornhorst A, Frost GS. Veganism and its relationship with insulin resistance and intramyocellular lipid. Eur J Clin Nutr. 2005 Feb;59(2):291-8. doi: 10.1038/sj.ejcn.1602076.
Background: PubMed 19167953Barnard ND, Gloede L, Cohen J, Jenkins DJ, Turner-McGrievy G, Green AA, Ferdowsian H. A low-fat vegan diet elicits greater macronutrient changes, but is comparable in adherence and acceptability, compared with a more conventional diabetes diet among individuals with type 2 diabetes. J Am Diet Assoc. 2009 Feb;109(2):263-72. doi: 10.1016/j.jada.2008.10.049.
Background: PubMed 12900694Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
Background: PubMed 17114290Petersen KF, Dufour S, Feng J, Befroy D, Dziura J, Dalla Man C, Cobelli C, Shulman GI. Increased prevalence of insulin resistance and nonalcoholic fatty liver disease in Asian-Indian men. Proc Natl Acad Sci U S A. 2006 Nov 28;103(48):18273-7. doi: 10.1073/pnas.0608537103. Epub 2006 Nov 17.
Background: PubMed 8350724Gruetter R. Automatic, localized in vivo adjustment of all first- and second-order shim coils. Magn Reson Med. 1993 Jun;29(6):804-11. doi: 10.1002/mrm.1910290613.
Background: PubMed 21808028Rabol R, Petersen KF, Dufour S, Flannery C, Shulman GI. Reversal of muscle insulin resistance with exercise reduces postprandial hepatic de novo lipogenesis in insulin resistant individuals. Proc Natl Acad Sci U S A. 2011 Aug 16;108(33):13705-9. doi: 10.1073/pnas.1110105108. Epub 2011 Aug 1.
Individual participant dataSharing planned: Undecided

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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.

Neal D Barnard, M.D. principal investigator

President

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Plant-based diet in people with Overweight and Obesity, run by Physicians Committee for Responsible Medicine at 1 site in United States.

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 2 inclusion and 14 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: finished, as of the sponsor's last update on 19 Jul 2023. 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 United States. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Body weight in kg (time frame: 16 weeks). The study lists 7 primary outcomes in all. 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 NCT02939638, which also lists 20 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 19 Jul 2023; AzTrials last refreshed its copy on 6 Nov 2026.