Standard Diet for Obesity

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Obesity
Protein powder supplement, standard dosage based on 0.5 gram protein per pound of subject's lean body mass - DietarySupplement
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study 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.

Treatment Effectiveness

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: Microbiome sampling at 2 weeks will be compared with microbiome composition at the end of the 16 week study period for each subject.

Week 16
Change from baseline liver characteristics as measured by fibroscan in response to dietary intervention
Week 16
Changes in microbiome composition in response to dietary intervention
Week 16
Weight loss in response to dietary intervention change

Trial Safety

Trial Design

2 Treatment Groups

Standard Diet
1 of 2
High Protein Diet
1 of 2

Active Control

216 Total Participants · 2 Treatment Groups

Primary Treatment: Standard Diet · No Placebo Group · N/A

Standard Diet
DietarySupplement
ActiveComparator Group · 1 Intervention: Protein powder supplement, standard dosage based on 0.5 gram protein per pound of subject's lean body mass · Intervention Types: DietarySupplement
High Protein Diet
DietarySupplement
ActiveComparator Group · 1 Intervention: Protein powder supplement, High Level Protein, based on 1 gram of protein per pound of lean body mass: 25% protein and 45% carbohydrate · Intervention Types: DietarySupplement

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: microbiome sampling at 2 weeks will be compared with microbiome composition at the end of the 16 week study period for each subject.

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,473 Previous Clinical Trials
2,741,522 Total Patients Enrolled
38 Trials studying Obesity
9,983 Patients Enrolled for Obesity
Jonathan P Jacobs, MD PhDPrincipal InvestigatorVA Greater Los Angeles Healthcare System, West Los Angeles, CA

Eligibility Criteria

Age 18 - 65 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
are the most productive People aged between 20 and 60 are the most productive.
smokers who are able to have a cigarette immediately prior to the first study visit and during each visit thereafter; individuals who are not willing or able to abstain from smoking for the duration of the study.
People who are not obese and are taking prescription medication may be included in the study.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 20th, 2021

Last Reviewed: November 1st, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
California100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
VA Greater Los Angeles Healthcare System, West Los Angeles, CA100.0%
What portion of applicants met pre-screening criteria?
Met criteria50.0%
Did not meet criteria50.0%
References