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Low-Fat Vegan Diet Versus a Mediterranean Diet on Body Weight

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ClinicalTrials.gov Identifier: NCT03698955
Recruitment Status : Active, not recruiting
First Posted : October 8, 2018
Last Update Posted : March 4, 2019
Sponsor:
Information provided by (Responsible Party):
Physicians Committee for Responsible Medicine

Tracking Information
First Submitted Date  ICMJE October 3, 2018
First Posted Date  ICMJE October 8, 2018
Last Update Posted Date March 4, 2019
Actual Study Start Date  ICMJE October 22, 2018
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 4, 2018)
  • Body weight [ Time Frame: Change in body weight from Baseline at 4 months ]
    Body weight will be assessed at the baseline and at the completion of both interventions.
  • Plasma lipids [ Time Frame: Change in plasma cholesterol, triglycerides, and HbA1c from Baseline at 4 months ]
    Plasma cholesterol, triglycerides, and HbA1c will be measured in a fasting state.
  • Insulin sensitivity [ Time Frame: Change in insulin sensitivity from Baseline at 4 months ]
    Insulin sensitivity will be assessed by the HOMA index.
  • Metabolism [ Time Frame: Changes in metabolism from Baseline at 4 months ]
    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 Quark 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 will be measured for three hours after the standard meal.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03698955 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 4, 2018)
  • Levels of Advanced Glycosylation Endproducts (AGEs) [ Time Frame: Change in Advanced Glycosylation Endproducts (AGEs) from Baseline at 4 months ]
    An AGE reader will be used to measure the Levels of the AGEs in the skin
  • Endothelial function [ Time Frame: Change in Endothelial function from Baseline at 4 months ]
    Endothelial function will be measured using the EndoPAT.
  • Microbiome analysis [ Time Frame: Change in Microbiome from Baseline at 4 months ]
    Microbiome analysis will be performed from participant-provided stool sample. Anticipated changes in the dietary intervention group include changes in the microbiome composition that correlate with changes in insulin sensitivity.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Low-Fat Vegan Diet Versus a Mediterranean Diet on Body Weight
Official Title  ICMJE A Randomized, Cross-Over Trial on the Effects of a Low-Fat Vegan Diet Versus a Mediterranean Diet on Body Weight
Brief Summary This randomized, cross-over trial aims to assess changes in body weight, plasma lipids, insulin sensitivity, and postprandial metabolism with a low-fat, plant-based diet and a Mediterranean diet, both followed for 4 months.
Detailed Description

In a 36-week cross-over trial, overweight adults will consume a low-fat vegan diet and a Mediterranean diet in two separate 16-week phases. Changes in body weight will be the primary dependent variable. In addition, plasma lipid concentrations, insulin sensitivity, and postprandial metabolism will also be assessed and changes over time will be compared between the two diets.

Participants will be randomly assigned to start either a low-fat vegan diet or a Mediterranean diet for 16 weeks. Both groups will receive weekly classes and support, and will be asked to make no changes to their exercise patterns for the study period. After a 4-week washout period, participants will cross over to the second dietary intervention for another 16 weeks.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Overweight
  • Obesity
  • Insulin Resistance
Intervention  ICMJE
  • Other: Plant-based diet
    Weekly instructions will be given to the participants in the intervention group about following the vegan diet.
    Other Name: Vegan diet
  • Other: Mediterranean Diet
    Weekly instructions will be given to the participants in the intervention group about following the Mediterranean diet.
Study Arms  ICMJE
  • Active Comparator: Plant-based diet
    The diet group will be asked to follow a low-fat, vegan diet for 16 weeks.
    Intervention: Other: Plant-based diet
  • Active Comparator: Mediterranean diet
    The diet group will be asked to follow a Mediterranean diet for 16 weeks.
    Intervention: Other: Mediterranean Diet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 1, 2019)
62
Original Estimated Enrollment  ICMJE
 (submitted: October 4, 2018)
50
Estimated Study Completion Date  ICMJE November 2019
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Diabetes mellitus type 1, history 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 (unstable dose within the preceding 6 months), systemic steroids, antidepressants (tricyclics, MAOIs, 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, as verified by self--- - Unstable medical or psychiatric illness
  • Evidence of an eating disorder
  • Likely to be disruptive in group sessions
  • Already following a low-fat vegan diet or Mediterranean 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03698955
Other Study ID Numbers  ICMJE Pro00029777
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Physicians Committee for Responsible Medicine
Study Sponsor  ICMJE Physicians Committee for Responsible Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Neal Barnard Physicians Committee for Responsible Medicine
PRS Account Physicians Committee for Responsible Medicine
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP