Effects of a Calorie Restricted, Very Low Fat Plant-based Diet and Multi-component Exercise Program on Metabolic Health

NCT02706288 | Completed DMC

• 1 other identifier: 201512088
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to understand how weight loss by a very low fat plant-based diet with an exercise program affects metabolic and cardiovascular health in overweight adults at high risk for disease. Outcome measures will include assessment of insulin sensitivity, β-cell function, body fat distribution, skeletal muscle and adipose tissue biology, cardiovascular function, cardiorespiratory fitness, muscular strength, immune function, and the gut microbiome.

Conditions

Obesity; Insulin Resistance

Outcome Measures

Primary Outcomes (1)

• Change in insulin sensitivity

  Liver and skeletal muscle insulin sensitivity will be assessed by hyperinsulinemic euglycemic clamp technique, before and after weight loss.

  An average of 4 months from baseline testing to 7-10% weight loss

Secondary Outcomes (18)

• Change in aerobic fitness

  An average of 4 months from baseline testing to 7-10% weight loss

• Change in muscular strength

  An average of 4 months from baseline testing to 7-10% weight loss

• Change in fat mass and fat free mass

  An average of 4 months from baseline testing to 7-10% weight loss

• Change in intra-hepatic triglyceride content

  An average of 4 months from baseline testing to 7-10% weight loss

• Change in fasting plasma glucose

  An average of 4 months from baseline testing to 7-10% weight loss

Study Arms (1)

Weight loss with diet with exercise

EXPERIMENTAL

Persons with obesity with blood glucose concentrations higher than recommended and a moderate to high amount of fat in the liver (people with metabolically abnormal obesity) will be tested before and after \~7-10% weight loss. Following baseline testing, participants will be placed on a caloric-restricted plant-based very-low-fat (PB) diet and an exercise program until \~7-10% weight loss is achieved; they will then be re-tested so that pre- and post-intervention outcomes can be compared.

Other: Weight loss with very low fat plant-based diet and regular exercise

Interventions

Weight loss with very low fat plant-based diet and regular exercise OTHER

Participants will lose \~7-10% of their body weight while on a calorie-restricted very low fat plant-based (PB) diet and performing exercise 6 days/week (4 sessions/week under direct supervision). The macronutrient composition of the diet is approximately 70% of energy from carbohydrate, 15% from protein, and 15% from fat. Food will be provided in the form of take-out meals and will be picked up by participants during weekly study visits with a weight management dietitian. To promote adherence to the diet and exercise intervention, subjects will participate in a lifestyle intervention program that includes dietary and behavioral education topics. Treatment will be provided in weekly individual or group sessions depending on subject availability. (Note: this is the only intervention for the study; the hyperinsulinemic euglycemic clamp is not an intervention but is the gold standard for evaluating insulin sensitivity, a primary study outcome.)

Weight loss with diet with exercise

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age ≥18 and ≤55 years
• BMI ≥30.0 and ≤50.0 kg/m²
• HbA1c ≥5.7%, or fasting plasma glucose concentration ≥100 mg/dl, or 2-hr OGTT plasma glucose concentration ≥140 mg/dl

You may not qualify if:

• Medical, surgical, or biological menopause
• Previous bariatric surgery
• Structured exercise \>2 days/week for ≥35 minutes of intense exercise (e.g., jogging, activity that causes heavy breathing and sweating) or ≥150 min per week of structured exercise (e.g., brisk walking)
• Unstable weight (\>4% change during the last 2 months before entering the study)
• Significant organ system dysfunction (e.g., diabetes requiring medications, severe pulmonary, kidney or cardiovascular disease)
• Cancer or cancer that has been in remission for \<5 years
• Polycystic ovary syndrome
• Major psychiatric illness
• Conditions that render subject unable to complete all testing procedures (e.g., severe ambulatory impairments, limb amputations, or metal implants that interfere with imaging procedures; coagulation disorders)
• Use of medications that are known to affect the study outcome measures (e.g., steroids, non-statin lipid lowering medications) or increase the risk of study procedures (e.g., anticoagulants) and that cannot be temporarily discontinued for this study
• Use of antibiotics in last 60 days
• Smoke cigarettes, use marijuana \>2 x/week, or use of illegal drugs
• Men who consume \>21 units (e.g. glass of wine or bottle of beer) of alcohol per week and women who consume \>14 units of alcohol per week
• Pregnant or lactating women
• Vegans, vegetarians, those with lactose intolerance and/or severe aversions/sensitivities to eggs, fish, nuts, wheat and soy, and/or any individuals with food allergies that induce an anaphylactic response

Sponsors & Collaborators

• Washington University School of Medicine: lead
• The Foundation for Barnes-Jewish Hospital: collaborator

Study Sites (1)

Washington University in St. Louis School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

• Beals JW, Kayser BD, Smith GI, Schweitzer GG, Kirbach K, Kearney ML, Yoshino J, Rahman G, Knight R, Patterson BW, Klein S. Dietary weight loss-induced improvements in metabolic function are enhanced by exercise in people with obesity and prediabetes. Nat Metab. 2023 Jul;5(7):1221-1235. doi: 10.1038/s42255-023-00829-4. Epub 2023 Jun 26.

  PMID: 37365374 DERIVED

MeSH Terms

Conditions

Obesity; Insulin Resistance

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Officials

• Samuel Klein, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2016
• First Posted: March 11, 2016
• Study Start: March 1, 2016
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2022
• Last Updated: December 8, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)