Ignite Creation Date:
2024-05-06 @ 3:56 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04812964
Status:
COMPLETED
Last Update Posted:
2024-04-19
First Post:
2021-03-11
Brief Title:
Modulation of the Intestinal Microbiome by a High Protein Diet
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Modulation of the Intestinal Microbiome in Obesity by a High Protein Diet
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HPD
Brief Summary:
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
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 11 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
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 11 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None