ObesityHPDNCT04812964

Modulation of the Intestinal Microbiome by a High Protein Diet

A study testing Protein powder supplement, standard dosage based on 0.5 gram protein per pound of subject's lean body mass and Protein powder supplement, High Level Protein, based on 1 gram of protein per pound of lean body mass: 25% protein and 45% carbohydrate in people with Obesity, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 20 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Obesity
What is being tested?: Protein powder supplement, standard dosage based on 0.5 gram protein per pound of subject's lean body mass and Protein powder supplement, High Level Protein, based on 1 gram of protein per pound of lean body mass: 25% protein and 45% carbohydrate
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 106 participants
Where: 1 siteUnited States
Study dates: 3 Apr 2018to 31 Mar 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 20 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Men and women between 20 and 60 years of age,
BMI 27 to 40 kg/m^2,
non-smoker or stable smoking habits for at least 6 months prior to screening and agreement not to change such habits during the study;
subjects on non-obesity prescription medication may be included.

Who cannot join

Weight change of >3.0 kg in the month prior to screening, weight loss of >10 kg in the 6 months prior to screening,
calorie restriction diet (<1500 kcal/day) for a period of 4 months or more in the 12 months prior to screening,
use of any other investigational drug(s) within 8 weeks prior to screening,
abnormal baseline laboratory parameters (serum creatinine > 1.6 mg/dl; ALT, AST, total bilirubin > 2.0 times the upper limit of normal;
triglycerides > 500 mg/dl, total cholesterol > 350 mg/dl, TSH outside of normal range),
consumption of more than 1 alcoholic beverage per day, pregnancy or intention to become pregnant.

Trial locations and contacts

1 site in 1 country.

United States1 site

VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, 90073-1003

Other trials in United States

About this study

Official title: Modulation of the Intestinal Microbiome in Obesity by a High Protein Diet

The objective of this study is to test and determine whether a high protein diet induces weight loss by modulating the composition and function of the intestinal microbiome in obesity. This will be investigated in a randomized clinical study comparing the effect of isocaloric high and normal protein diets on the intestinal microbiome composition, gene content, and metabolome of obese subjects.

Read the detailed description

A high protein diet has been shown in preclinical rodent models and clinical trials to be an effective obesity treatment that is associated with greater loss of body weight and fat mass and increased satiety compared to isocaloric standard protein diets. However, the mechanisms of this response have not been fully elucidated. The investigators recently demonstrated in a rodent model that a high protein diet induces shifts in the intestinal microbiome including a bloom of Akkermansia muciniphila, a microbe reported to have an anti-obesity effect. Based on these preliminary studies, the investigators hypothesize that a high protein diet induces alterations in the intestinal microbiome that mediate its clinical efficacy for obesity.

More than three quarters of Veterans are overweight or obese, making obesity a public health problem of tremendous importance to the VA medical system. The results of the proposed study will provide insight into the specific microbes that drive the clinical response to a high protein diet and may identify candidate anti-obesity microbes that could be further developed into novel microbial therapeutics. More broadly, establishing a microbiome-dependent mechanism for the efficacy of a dietary intervention would be a breakthrough in the investigators' understanding of obesity treatment. It would pave the way for larger scale clinical and translational studies investigating the role of the microbiota in other diets and for the development of microbial therapeutics used alone or in combination with dietary intervention to treat obese Veterans.

To investigate the role of the intestinal microbiome in mediating the effect of a high protein diet, the investigators will study 216 overweight and obese Veterans (BMI 27) who will be randomized 1:1 to isocaloric high protein (30%) or normal protein (15%) 1500 calorie diets for 16 weeks utilizing existing clinical infrastructure at the West Los Angeles VA Medical Center established for a recently completed clinical trial of a high protein diet. In Aim 1, the effect of a high protein diet on the composition and function of the intestinal microbiome will be assessed by 16S rRNA sequencing, shotgun metagenomics, and metabolomics. In Aim 2, bioinformatics analysis will be performed to identify fecal microbes, bacterial genes, and metabolites that are associated with weight loss, reduced body fat, decreased hepatic steatosis, altered lipid profiles, reduced hemoglobin A1c, decreased high sensitivity C-reactive protein, increased satiety, and circulating levels of hormones affecting satiety (leptin, ghrelin glucagon, glucagon-like peptide-1, peptide YY).

Conditions: Obesity
Being tested: Protein powder supplement, standard dosage based on 0.5 gram protein per pound of subject's lean body mass, Protein powder supplement, High Level Protein, based on 1 gram of protein per pound of lean body mass: 25% protein and 45% carbohydrate
Keywords: Obesity, Microbiome, High protein diet
Medical subject headings: Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Protein powder supplement, standard dosage based on 0.5 gram protein per pound of subject's lean body massDietary supplement
Also called Standard Protein Diet
Standard protein diet as control, based on 0.5 gram protein per pound of lean body mass, isocaloric (same number of calories) and consisting of 15% protein and 55% carbohydrate.
Protein powder supplement, High Level Protein, based on 1 gram of protein per pound of lean body mass: 25% protein and 45% carbohydrateDietary supplement
Also called High Protein Diet
High level of protein diet, based on 1 gram of protein per pound of subject's lean body mass, isocaloric (same number of calories) and consisting of 30% protein and 40% carbohydrate.

Study groups in NCT04812964
Study group	Role	What they receive
Standard Diet	Active comparator	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. Receives: Dietary Supplement: Protein powder supplement, standard dosage based on 0.5 gram protein per pound of subject's lean body mass
High Protein Diet	Active comparator	High protein diet group based on 1 gram of protein per pound of lean body mass: 30% protein and 40% carbohydrate. Receives: Dietary Supplement: Protein powder supplement, High Level Protein, based on 1 gram of protein per pound of lean body mass: 25% protein and 45% carbohydrate

What is being measured

The primary outcome is the main question the study is designed to answer.

Weight Loss (% Change) in Response to Dietary Intervention Change
The primary objective is to compare weight loss between each of the two diets, a high-protein diet versus a standard protein diet.
Measured: Primary outcome of weight loss is measured by subtracting the baseline weight on Day 1 from the weight at the end of the 16 week study period for each subject, and converting to % of baseline weight.

Secondary outcomes (2)

Change in Steatosis From Baseline as Measured by Fibroscan in Response to Dietary Intervention
Association of change in fat mass on a high protein diet versus standard protein diet will be measured by Fibroscan (CAP score).
Measured: Changes in liver steatosis will be measured at baseline and at the end of the 16 week study period for each subject.
Change in Liver Fibrosis From Baseline as Measured by Fibroscan in Response to Dietary Intervention
Association of change in hepatic fibrosis on a high protein diet versus standard protein diet will be measured by Fibroscan elastography.
Measured: Changes in liver steatosis will be measured at baseline and at the end of the 16 week study period for each subject.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Apr 201831 Mar 2024

First posted24 Mar 2021
Study start3 Apr 2018
Primary completion19 Jul 2023
Study completion31 Mar 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for ObesityStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe 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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 106 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04812964
Sponsor's protocol ID: GAST-030-17S
Acronym: HPD
Status last verified: Jul 2024
First submitted: 11 Mar 2021
Last updated: 7 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Vu JP, Luong L, Parsons WF, Oh S, Sanford D, Gabalski A, Lighton JR, Pisegna JR, Germano PM. Long-Term Intake of a High-Protein Diet Affects Body Phenotype, Metabolism, and Plasma Hormones in Mice. J Nutr. 2017 Dec;147(12):2243-2251. doi: 10.3945/jn.117.257873. Epub 2017 Oct 25.
PubMed 29070713
Dong TS, Luu K, Lagishetty V, Sedighian F, Woo SL, Dreskin BW, Katzka W, Chang C, Zhou Y, Arias-Jayo N, Yang J, Ahdoot A, Li Z, Pisegna JR, Jacobs JP. A High Protein Calorie Restriction Diet Alters the Gut Microbiome in Obesity. Nutrients. 2020 Oct 21;12(10):3221. doi: 10.3390/nu12103221.
PubMed 33096810
Stengel A, Goebel-Stengel M, Wang L, Hu E, Karasawa H, Pisegna JR, Tache Y. High-protein diet selectively reduces fat mass and improves glucose tolerance in Western-type diet-induced obese rats. Am J Physiol Regul Integr Comp Physiol. 2013 Sep 15;305(6):R582-91. doi: 10.1152/ajpregu.00598.2012. Epub 2013 Jul 24.
PubMed 23883680

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Modulation of the Intestinal Microbiome in Obesity by a High Protein Diet
ClinicalTrials.gov ID: NCT04812964
Acronym / sponsor ID: HPD / GAST-030-17S
Conditions: Obesity
Keywords: Obesity, Microbiome, High protein diet
Study type: Interventional
Recruitment status: Completed
Enrolment: 106 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: 3 Apr 2018 (actual)
Primary completion: 19 Jul 2023 (actual)
Study completion: 31 Mar 2024 (actual)
First posted: 24 Mar 2021 (actual)
Results: Posted 7 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Standard Diet	Active comparator	Dietary Supplement: Protein powder supplement, standard dosage based on 0.5 gram protein per pound of subject's lean body massStandard 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.
High Protein Diet	Active comparator	Dietary Supplement: Protein powder supplement, High Level Protein, based on 1 gram of protein per pound of lean body mass: 25% protein and 45% carbohydrateHigh protein diet group based on 1 gram of protein per pound of lean body mass: 30% protein and 40% carbohydrate.

Who may qualify

Ages: 20 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Men and women between 20 and 60 years of age,
BMI 27 to 40 kg/m^2,
non-smoker or stable smoking habits for at least 6 months prior to screening and agreement not to change such habits during the study;
subjects on non-obesity prescription medication may be included.

Key exclusion criteria (6 listed)

Weight change of >3.0 kg in the month prior to screening, weight loss of >10 kg in the 6 months prior to screening,
calorie restriction diet (<1500 kcal/day) for a period of 4 months or more in the 12 months prior to screening,
use of any other investigational drug(s) within 8 weeks prior to screening,
abnormal baseline laboratory parameters (serum creatinine > 1.6 mg/dl; ALT, AST, total bilirubin > 2.0 times the upper limit of normal;
triglycerides > 500 mg/dl, total cholesterol > 350 mg/dl, TSH outside of normal range),

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
Protein powder supplement, standard dosage based on 0.5 gram protein per pound of subject's lean body massAlso: Standard Protein DietStandard protein diet as control, based on 0.5 gram protein per pound of lean body mass, isocaloric (same number of calories) and consisting of 15% protein and 55% carbohydrate.	Dietary supplement	Standard Diet
Protein powder supplement, High Level Protein, based on 1 gram of protein per pound of lean body mass: 25% protein and 45% carbohydrateAlso: High Protein DietHigh level of protein diet, based on 1 gram of protein per pound of subject's lean body mass, isocaloric (same number of calories) and consisting of 30% protein and 40% carbohydrate.	Dietary supplement	High Protein Diet

Primary outcome

Weight Loss (% Change) in Response to Dietary Intervention Change
Time frame: Primary outcome of weight loss is measured by subtracting the baseline weight on Day 1 from the weight at the end of the 16 week study period for each subject, and converting to % of baseline weight.
The primary objective is to compare weight loss between each of the two diets, a high-protein diet versus a standard protein diet.

2 secondary outcomes

Change in Steatosis From Baseline as Measured by Fibroscan in Response to Dietary Intervention
Time frame: Changes in liver steatosis will be measured at baseline and at the end of the 16 week study period for each subject.
Change in Liver Fibrosis From Baseline as Measured by Fibroscan in Response to Dietary Intervention
Time frame: Changes in liver steatosis will be measured at baseline and at the end of the 16 week study period for each subject.

Results and safety

Results posted to the registry on 7 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard Diet	40	31
High Protein Diet	47	27

Primary outcome: Weight Loss (% Change) in Response to Dietary Intervention Change

Time frame: Primary outcome of weight loss is measured by subtracting the baseline weight on Day 1 from the weight at the end of the 16 week study period for each subject, and converting to % of baseline weight.. Mean (Standard Error). Unit: percentage weight change from baseline

Measure	Standard Diet n = 31	High Protein Diet n = 27
Value	-3.83 (0.75)	-3.89 (0.74)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 16 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard Diet	0 of 40 (0%)	0 of 40 (0%)	0 of 40
High Protein Diet	0 of 47 (0%)	0 of 47 (0%)	0 of 47

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 29070713Vu JP, Luong L, Parsons WF, Oh S, Sanford D, Gabalski A, Lighton JR, Pisegna JR, Germano PM. Long-Term Intake of a High-Protein Diet Affects Body Phenotype, Metabolism, and Plasma Hormones in Mice. J Nutr. 2017 Dec;147(12):2243-2251. doi: 10.3945/jn.117.257873. Epub 2017 Oct 25.
Background: PubMed 33096810Dong TS, Luu K, Lagishetty V, Sedighian F, Woo SL, Dreskin BW, Katzka W, Chang C, Zhou Y, Arias-Jayo N, Yang J, Ahdoot A, Li Z, Pisegna JR, Jacobs JP. A High Protein Calorie Restriction Diet Alters the Gut Microbiome in Obesity. Nutrients. 2020 Oct 21;12(10):3221. doi: 10.3390/nu12103221.
Background: PubMed 23883680Stengel A, Goebel-Stengel M, Wang L, Hu E, Karasawa H, Pisegna JR, Tache Y. High-protein diet selectively reduces fat mass and improves glucose tolerance in Western-type diet-induced obese rats. Am J Physiol Regul Integr Comp Physiol. 2013 Sep 15;305(6):R582-91. doi: 10.1152/ajpregu.00598.2012. Epub 2013 Jul 24.
Individual participant dataSharing planned: No

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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.

Jonathan P Jacobs, MD PhD principal investigator

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 6 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 7 Aug 2024. 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?

Yes. Results are posted in the registry (first posted 7 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Weight Loss (% Change) in Response to Dietary Intervention Change (time frame: Primary outcome of weight loss is measured by subtracting the baseline weight on Day 1 from the weight at the end of the 16 week study period for each subject, and converting to % of baseline weight.). 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 NCT04812964, which also lists 3 linked publications.

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 7 Aug 2024.