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Dietary Supplement
High Protein Diet for Obesity (HPD Trial)
N/A
Waitlist Available
Led By Jonathan P Jacobs, MD PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Men and women between 20 and 60 years of age
Be between 18 and 65 years old
Must not have
Calorie restriction diet (<1500 kcal/day) for a period of 4 months or more in the 12 months prior to screening
Weight loss of >10 kg in the 6 months prior to screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up microbiome sampling at 2 weeks will be compared with microbiome composition at the end of the 16 week study period for each subject.
Awards & highlights
Summary
This trial will test whether a high protein diet helps with weight loss by changing the mix of bacteria in the gut, and whether this leads to different metabolism.
Who is the study for?
This trial is for men and women aged 20-60 with obesity (BMI between 27 to 40), who are either non-smokers or have not changed their smoking habits in the last six months. Participants can be on medications unrelated to obesity but mustn't have had significant weight changes recently, been on a low-calorie diet, or used investigational drugs shortly before the study.Check my eligibility
What is being tested?
The study tests if high protein diets affect weight loss by changing gut bacteria. It compares two groups: one taking a standard protein dose based on body mass, and another taking double that amount. Both groups receive an equal calorie intake to see how different protein levels impact the intestinal microbiome.See study design
What are the potential side effects?
Potential side effects from high protein diets may include digestive discomfort such as bloating or constipation, kidney strain in susceptible individuals, bad breath, and possibly an increase in some heart disease risk factors.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 20 and 60 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been on a diet of less than 1500 calories a day for 4 months in the last year.
Select...
I have lost more than 10 kg in the last 6 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ microbiome sampling at 2 weeks will be compared with microbiome composition at the end of the 16 week study period for each subject.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~microbiome sampling at 2 weeks will be compared with microbiome composition at the end of the 16 week study period for each subject.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Weight loss in response to dietary intervention change
Secondary outcome measures
Change from baseline liver characteristics as measured by fibroscan in response to dietary intervention
Changes in microbiome composition in response to dietary intervention
Trial Design
2Treatment groups
Active Control
Group I: Standard DietActive Control1 Intervention
Standard protein diet group as control based on 0.5 gram protein per pound of lean body mass with same calories: 15% protein and 55% carbohydrate.
Group II: High Protein DietActive Control1 Intervention
High protein diet group based on 1 gram of protein per pound of lean body mass: 30% protein and 40% carbohydrate.
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,628 Previous Clinical Trials
3,325,873 Total Patients Enrolled
40 Trials studying Obesity
9,941 Patients Enrolled for Obesity
Jonathan P Jacobs, MD PhDPrincipal InvestigatorVA Greater Los Angeles Healthcare System, West Los Angeles, CA
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