RecruitingNot ApplicableNCT06373887

The Efficacy of Weight-loss Diet Decision-making Based on Initial Gut Metabolic Modules (GMMs)

Sponsor

Taipei Veterans General Hospital, Taiwan

Enrollment

150 participants

Start Date

Apr 10, 2024

Study Type

INTERVENTIONAL

Conditions

Weight Loss

Summary

In recent years, the technology to detect the gut microbiome's function has become increasingly developed. GMMs are tools (GitHub - raeslab/GMMs: A manually curated database of human gut metabolic modules.) for describing metabolic pathways for linking microbial metabolic function to species associated with a single metabolite, helping to analyze the transcriptional characteristics and metabolic functions of each bacterium, and studying their role of the food chain in the ecosystem. According to our previous research, the group with good weight loss response (more than 10% body weight loss in 8 weeks) after low-carb diet intervention has higher Shannon's diversity and carbohydrate degradation activity test by GMMs, implying the deficiency of availability of energy sources may cause more weight changes. Based on the above research, we designed a low-carb diet (rich in monounsaturated fatty acids) and a low-fat diet (whole grains) with the same calories as a means of weight loss. The primary purpose of this study is to evaluate the pre-GMM test for determines the weight loss benefit of the intervention diet. Furthermore, we try to found the possible mechanism of whether metabolites of microbiota (e.g. SCFA) could affect the immune cell change which modulates adipose tissue .

Eligibility

Min Age: 20 YearsMax Age: 64 Years

Inclusion Criteria1

Patients with BMI >=24 overweight and obesity without chronic disease or medication use.

Exclusion Criteria5

a) Medication history of diabetes, hypertension, dyslipidemia, and cardiovascular diseases within two months.
b) Bodyweight change within three months before the study. (+4kg). c) Participate in weight loss programs in the preceding 12 months. d) Use ABX, PPI, NSAID, laxatives, oral contraceptives, and antipsychotics within two months.
e) Previous operations history for managing obesity (bariatric procedures and gastric bypass operation).
f) Current smoking: at least 20 monthly cigarettes for over half a year. g) Alcohol consumption (> two glasses per day). h) Pregnancy, breastfeeding, chronic kidney dis-ease, autoimmune, viral chronic diseases (hepatitis C, B, HIV, etc.), and neoplastic diseases.
i) Consumption of vegetarian or unusual diets. The Institutional Review Board approved all study protocols at TVGH.

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Interventions

DIETARY_SUPPLEMENTplant-based Low carbohydrate diet

In the research, the high, medium, low carbohydrate degradation subjects were randomized to either plant-based Low carbohydrate diet or low fat diet to loss weight.

DIETARY_SUPPLEMENTplant-based Low low fat diet

In the research, the high, medium, low carbohydrate degradation subjects were randomized to either plant-based Low carbohydrate diet or low fat diet to loss weight.