Obesity Clinical Trial
— HPDOfficial title:
Modulation of the Intestinal Microbiome in Obesity by a High Protein Diet
Verified date | April 2024 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 106 |
Est. completion date | March 31, 2024 |
Est. primary completion date | July 19, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 60 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | VA Greater Los Angeles Healthcare System, West Los Angeles, CA | West Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Weight loss 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. | Primary outcome of weight loss is measured at the baseline on Day 1 and at the end of the 16 week study period for each subject. | |
Secondary | Change from baseline liver characteristics as measured by fibroscan in response to dietary intervention | Association of change in fat mass and liver steatosis on a high protein diet versus standard protein diet will be measured by fibroscan. | Changes in liver fibrosis and liver steatosis will be measured at baseline and at the end of the 16 week study period for each subject. | |
Secondary | Changes in microbiome composition in response to dietary intervention | Changes to the intestinal microbiome will be assessed on a high protein diet compared to a standard protein diet. | Microbiome sampling at 2 weeks will be compared with microbiome composition at the end of the 16 week study period for each subject. |
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