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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
Subjects on non-obesity prescription medication may be included
Men and women between 20 and 60 years of age
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

HPD Trial 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.

HPD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am taking prescription medication not for obesity.
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I am between 20 and 60 years old.
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I am taking prescription medication not for obesity.
Select...
I am between 20 and 60 years old.

HPD Trial 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.
This trial's timeline: 3 weeks for screening, Varies for treatment, and microbiome sampling at 2 weeks will be compared with microbiome composition at the end of the 16 week study period for each subject. for reporting.

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

HPD 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
1,607 Previous Clinical Trials
3,305,929 Total Patients Enrolled
40 Trials studying Obesity
9,981 Patients Enrolled for Obesity
Jonathan P Jacobs, MD PhDPrincipal InvestigatorVA Greater Los Angeles Healthcare System, West Los Angeles, CA

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies available for volunteers in this investigation?

"Clinicaltrials.gov data confirms that this research project is actively looking for willing participants, first advertised on April 3rd 2018 and most recently revised March 1st 2022."

Answered by AI

Does this research extend to individuals aged 85 or above?

"The qualifications for this study necessitate that participating patients are between the ages of 20 and 60. By contrast, there exist 202 trials designed to assist those below 18 years old while 596 studies target individuals 65 or above."

Answered by AI

Might I be qualified to participate in this medical study?

"The parameters for this research include a diagnosis of obesity and an age range between two decades. At the moment, there is need to recruit 216 candidates that meet these prerequisites."

Answered by AI

How many participants are eligible for enrollment in this scientific experiment?

"Affirmative. Clinicaltrials.gov hosts evidence indicating that the study is currently enrolling volunteers; it was initially posted on April 3rd 2018 and recently updated March 1st 2022. The investigation requires 216 participants from a single medical institution."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

Since menopause I’ve gained weight that is extremely hard to lose.
PatientReceived 1 prior treatment
Recent research and studies
~15 spots leftby Apr 2025