ObesityPENCT02706288
Effects of a Calorie Restricted, Very Low Fat Plant-based Diet and Multi-component Exercise Program on Metabolic Health
A study testing Weight loss with very low fat plant-based diet and regular exercise in people with Obesity and Insulin Resistance, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Insulin Resistance
- What is being tested?
- Weight loss with very low fat plant-based diet and regular exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Dec 2022
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
- Persons who are not able to grant voluntary informed consent
- Persons who are unable or unwilling to follow the study protocol or who, for any reason, the research team considers not an appropriate candidate for this study, including non-compliance with screening appointments or study visits
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University in St. Louis School of Medicine
St Louis, Missouri, 63110
About this study
Official title: The Effects of a Calorie Restricted, Very Low Fat Plant-based Diet and Multi-component Exercise Program on Metabolic Health in Metabolically Abnormal Obese Adults
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.
Read the detailed description
Reduced energy intake and increased physical activity have profound effects on cardiometabolic health as assessed by insulin sensitivity, β-cell function, serum lipids, intra-abdominal fat mass, intrahepatic triglyceride content, and blood pressure, and is the cornerstone of treatment for people with obesity. However, the specific additional therapeutic effects of regular exercise in conjunction with diet-induced weight loss are not clear. In addition, the optimal dietary macronutrient composition needed to reduce cardiometabolic risk is not known. The use of a very low fat, plant-forward diet is becoming increasingly popular to treat people with obesity and is the only diet therapy that is reimbursed by Medicare in the treatment of people with coronary heart disease.
Participants will undergo nutritional counseling and have supervised exercise training 4 days per week plus unsupervised exercise sessions performed 2 days per week until 7-10% weight loss is achieved. Meals will be provided and food diaries will be kept during weight loss. Tests before and after the intervention will include muscular strength and aerobic fitness, cardiovascular assessments, glucose tolerance tests, hyperinsulinemic euglycemic clamp test for insulin sensitivity, muscle biopsies, body composition scans, blood tests, and urine and stool collections.
The overarching goal of this project is to conduct a comprehensive characterization of weight loss induced by using a PB diet with regular exercise in people with obesity, prediabetes and insulin resistance, followed by a comparison of the effects of this study with those from another study that is evaluating the effect of the same amount of weight loss induced by using a PB diet alone, without exercise. Specifically, we will evaluate changes in body composition, body fat distribution, cardiopulmonary function, muscle strength, the plasma proteome, insulin sensitivity, beta-cell function, systemic inflammation, muscle cellular metabolic pathways, and the gut microbiome to determine cellular, multiorgan, and whole-body effects of PB diet alone and PB diet plus exercise. Accordingly, this study will fill two important gaps in our knowledge that have considerable physiological and clinical significance; the data from this study will provide: 1) a better understanding of the effects of calorie restriction-induced weight loss plus exercise on a series of key outcome measures, and 2) the potential additional benefit of adding regular exercise to a plant-forward diet.
- Conditions
- Obesity, Insulin Resistance
- Being tested
- Weight loss with very low fat plant-based diet and regular exercise
- Medical subject headings
- Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight loss with very low fat plant-based diet and regular exerciseOther
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.)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Weight loss with very low fat plant-based diet and regular exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in insulin sensitivity
Liver and skeletal muscle insulin sensitivity will be assessed by hyperinsulinemic euglycemic clamp technique, before and after weight loss.
Measured: An average of 4 months from baseline testing to 7-10% weight loss
Secondary outcomes (18)
Change in aerobic fitness
Maximal oxygen consumption will be assessed using indirect calorimetry during a graded exercise test to volitional fatigue, before and after weight loss.
Measured: An average of 4 months from baseline testing to 7-10% weight loss
Change in muscular strength
Muscle strength will be evaluated as the maximal amount of weight the participant is able to lift for one repetition (1 RM) for the following exercises: leg press, seated row, knee flexion, and chest press, before and after weight loss.
Measured: An average of 4 months from baseline testing to 7-10% weight loss
Change in fat mass and fat free mass
Fat mass and fat free mass will be assessed using dual-energy x-ray absorptiometry (DXA) before and after weight loss.
Measured: An average of 4 months from baseline testing to 7-10% weight loss
Change in intra-hepatic triglyceride content
Intra-hepatic triglyceride content will be assessed by magnetic resonance imaging (MRI) before and after weight loss.
Measured: An average of 4 months from baseline testing to 7-10% weight loss
Change in fasting plasma glucose
Fasting plasma glucose concentrations will be evaluated from a fasting blood sample before and after weight loss.
Measured: An average of 4 months from baseline testing to 7-10% weight loss
Change in glycosylated hemoglobin (HbA1c)
HbA1c will be evaluated from a fasting blood sample before and after weight loss.
Measured: An average of 4 months from baseline testing to 7-10% weight loss
Change in 24 hour glucose concentrations with feeding
Glucose concentrations will be evaluated from frequent blood samples over a 24 h period, before and after weight loss, with the participant consuming mixed meals throughout the day.
Measured: An average of 4 months from baseline testing to 7-10% weight loss
Change in 24 hour metabolite concentrations with feeding
Metabolite concentrations will be evaluated from frequent blood samples over a 24 h period, before and after weight loss, with the participant consuming mixed meals throughout the day.
Measured: An average of 4 months from baseline testing to 7-10% weight loss
Change in 24 hour hormone concentrations with feeding
Hormone concentrations will be evaluated from frequent blood samples over a 24 h period, before and after weight loss, with the participant consuming mixed meals throughout the day.
Measured: An average of 4 months from baseline testing to 7-10% weight loss
Change in markers of inflammation
Markers of inflammation will be evaluated from blood samples collected before and after weight loss.
Measured: An average of 4 months from baseline testing to 7-10% weight loss
Change in plasma proteome
Plasma proteome will be evaluated from blood samples collected before and after weight loss.
Measured: An average of 4 months from baseline testing to 7-10% weight loss
Changes in gene expression in skeletal muscle tissue
Gene expression in thigh muscle tissue will be evaluated before and after weight loss.
Measured: An average of 4 months from baseline testing to 7-10% weight loss
Changes in body weight
Body weight will be measured before and after weight loss.
Measured: An average of 4 months from baseline testing to 7-10% weight loss
Changes in body mass index
Body mass index will be calculated from weight and height before and after weight loss.
Measured: An average of 4 months from baseline testing to 7-10% weight loss
Change in exosome-mediated intercellular signaling
Signaling between cells and organs will be examined by isolating exosomes (small extracellular vesicles) from blood
Measured: An average of 4 months from baseline testing to 7-10% weight loss
Change in gut microbiome
Gut microbiota, meta-transcriptome (bacterial RNA sequencing to determine what proteins can be made by the microbiota) and the meta-metabolome (metabolites made by the microbiota) will be assessed before and after weight loss.
Measured: An average of 4 months from baseline testing to 7-10% weight loss
Change in beta-cell function
Beta-cell function will be assessed from a modified oral glucose tolerance test before and after weight loss.
Measured: An average of 4 months from baseline testing to 7-10% weight loss
Change in insulin clearance
Beta-cell function will be assessed from a modified oral glucose tolerance test and during the 24-hour study performed before and after weight loss.
Measured: An average of 4 months from baseline testing to 7-10% weight loss
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2020
- Study completionDec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- The Foundation for Barnes-Jewish Hospital
- Responsible party
- Sponsor
- Investigators
- Samuel Klein, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02706288
- Sponsor's protocol ID
- 201512088
- Acronym
- PE
- Status last verified
- Dec 2022
- First submitted
- 16 Feb 2016
- Last updated
- 8 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All of the data from individual subjects will be maintained confidentially and their names and identities will not be disclosed in any published document.
Publications
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.
PubMed 37365374
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Calorie Restricted, Very Low Fat Plant-based Diet and Multi-component Exercise Program on Metabolic Health in Metabolically Abnormal Obese Adults
- ClinicalTrials.gov ID
- NCT02706288
- Acronym / sponsor ID
- PE / 201512088
- Conditions
- Obesity, Insulin Resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- The Foundation for Barnes-Jewish Hospital
- Study start
- Mar 2016 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2022 (actual)
- First posted
- 11 Mar 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.
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.
Detailed description
Reduced energy intake and increased physical activity have profound effects on cardiometabolic health as assessed by insulin sensitivity, β-cell function, serum lipids, intra-abdominal fat mass, intrahepatic triglyceride content, and blood pressure, and is the cornerstone of treatment for people with obesity. However, the specific additional therapeutic effects of regular exercise in conjunction with diet-induced weight loss are not clear. In addition, the optimal dietary macronutrient composition needed to reduce cardiometabolic risk is not known. The use of a very low fat, plant-forward diet is becoming increasingly popular to treat people with obesity and is the only diet therapy that is reimbursed by Medicare in the treatment of people with coronary heart disease.
Participants will undergo nutritional counseling and have supervised exercise training 4 days per week plus unsupervised exercise sessions performed 2 days per week until 7-10% weight loss is achieved. Meals will be provided and food diaries will be kept during weight loss. Tests before and after the intervention will include muscular strength and aerobic fitness, cardiovascular assessments, glucose tolerance tests, hyperinsulinemic euglycemic clamp test for insulin sensitivity, muscle biopsies, body composition scans, blood tests, and urine and stool collections.
The overarching goal of this project is to conduct a comprehensive characterization of weight loss induced by using a PB diet with regular exercise in people with obesity, prediabetes and insulin resistance, followed by a comparison of the effects of this study with those from another study that is evaluating the effect of the same amount of weight loss induced by using a PB diet alone, without exercise. Specifically, we will evaluate changes in body composition, body fat distribution, cardiopulmonary function, muscle strength, the plasma proteome, insulin sensitivity, beta-cell function, systemic inflammation, muscle cellular metabolic pathways, and the gut microbiome to determine cellular, multiorgan, and whole-body effects of PB diet alone and PB diet plus exercise. Accordingly, this study will fill two important gaps in our knowledge that have considerable physiological and clinical significance; the data from this study will provide: 1) a better understanding of the effects of calorie restriction-induced weight loss plus exercise on a series of key outcome measures, and 2) the potential additional benefit of adding regular exercise to a plant-forward diet.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Weight loss with diet with exercise | Experimental | Other: Weight loss with very low fat plant-based diet and regular exercisePersons 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (17 listed)
- 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)
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 |
|---|---|---|
| Weight loss with very low fat plant-based diet and regular exerciseParticipants 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.) | Other | Weight loss with diet with exercise |
Primary outcome
Change in insulin sensitivity
Time frame: An average of 4 months from baseline testing to 7-10% weight loss
Liver and skeletal muscle insulin sensitivity will be assessed by hyperinsulinemic euglycemic clamp technique, before and after weight loss.
18 secondary outcomes
Change in aerobic fitness
Time frame: An average of 4 months from baseline testing to 7-10% weight loss
Change in muscular strength
Time frame: An average of 4 months from baseline testing to 7-10% weight loss
Change in fat mass and fat free mass
Time frame: An average of 4 months from baseline testing to 7-10% weight loss
Change in intra-hepatic triglyceride content
Time frame: An average of 4 months from baseline testing to 7-10% weight loss
Change in fasting plasma glucose
Time frame: An average of 4 months from baseline testing to 7-10% weight loss
Change in glycosylated hemoglobin (HbA1c)
Time frame: An average of 4 months from baseline testing to 7-10% weight loss
Change in 24 hour glucose concentrations with feeding
Time frame: An average of 4 months from baseline testing to 7-10% weight loss
Change in 24 hour metabolite concentrations with feeding
Time frame: An average of 4 months from baseline testing to 7-10% weight loss
Change in 24 hour hormone concentrations with feeding
Time frame: An average of 4 months from baseline testing to 7-10% weight loss
Change in markers of inflammation
Time frame: An average of 4 months from baseline testing to 7-10% weight loss
Change in plasma proteome
Time frame: An average of 4 months from baseline testing to 7-10% weight loss
Changes in gene expression in skeletal muscle tissue
Time frame: An average of 4 months from baseline testing to 7-10% weight loss
Changes in body weight
Time frame: An average of 4 months from baseline testing to 7-10% weight loss
Changes in body mass index
Time frame: An average of 4 months from baseline testing to 7-10% weight loss
Change in exosome-mediated intercellular signaling
Time frame: An average of 4 months from baseline testing to 7-10% weight loss
Change in gut microbiome
Time frame: An average of 4 months from baseline testing to 7-10% weight loss
Change in beta-cell function
Time frame: An average of 4 months from baseline testing to 7-10% weight loss
Change in insulin clearance
Time frame: An average of 4 months from baseline testing to 7-10% weight loss
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 8 Dec 2022.
- Derived from this study: PubMed 37365374Beals 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.
- Individual participant dataSharing planned: No. All of the data from individual subjects will be maintained confidentially and their names and identities will not be disclosed in any published document.
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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.
Samuel Klein, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight loss with very low fat plant-based diet and regular exercise in people with Obesity and Insulin Resistance, run by Washington University School of 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 3 inclusion and 17 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 8 Dec 2022. 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?
Change in insulin sensitivity (time frame: An average of 4 months from baseline testing to 7-10% weight loss). 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 NCT02706288, which also lists 1 linked publication.
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 8 Dec 2022.