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临床试验/NCT06373887
NCT06373887招募中不适用

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

Taipei Veterans General Hospital, Taiwan2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年4月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
150
试验地点
2
主要终点
Body weight loss/fat mass loss

研究概览

简要总结

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 .

详细描述

Many studies have shown that dysbiosis of gut microbiota is related to obesity and metabolic diseases4. Since there are many clinical guidelines for weight loss dietary recommendations that have been developed, successful long-term weight loss was still a challenge due to the personal variation of multi-omics markers at baseline and distinct diet-host-microbiome interaction1,2. A recent study2 related to successful long-term weight loss has found that the baseline microbiota composition and energy utilized patterns are related to the efficacy of long-term weight loss; The population with higher respiratory quotient (RQ) at baseline had significantly more weight loss when participating in a low-carb weight loss diet, suggesting that individuals with carbs as their main energy source had greater weight loss benefits when reducing carb sources. In our previous study, we also found that after the intervention of a low-carb diet (LCD), the groups with better weight loss results had higher diversity at the baseline, and the groups with better weight loss showed more active carbohydrate degradation using gut metabolic modules (GMMs) analysis. In contrast, one study5 showed an increased abundance of the genus (Dialister) encoding carbohydrate-active enzymes gene was associated with unsuccessful body weight loss when intervening with a weight-loss diet enriched with carbohydrates (Volumetric Diet). According to a recent study2 comparing a low-carb diet (LCD) and low-fat diet (LFD) for long-term weight loss, the LCD with a higher ratio of monounsaturated fatty acid (MUFA): saturated fatty acid (SFA) showed a better weight-loss response, while LFD with whole grain carbohydrate had better weight-loss response than refined grain carbohydrate. However, the weight loss efficacy between two diet arm within people with different carb degradation activities at the baseline was still unclear.

So far, there are no studies that use microbiota GMMs analysis before deciding which diet to intervene. Therefore, our study aims to investigate whether pre-examination and then intervention can bring benefits to weight loss efficacy.

Before the two dietary interventions, fecal microbiota analysis will be conducted to understand the metabolic activity of carbohydrates and then determine whether to enter the low-carbohydrate group or the low-fat group. The participants in this study will be divided into two groups: one group will have their gut microbiota measured before receiving dietary treatment, while the other group will be randomly assigned to one of the two dietary groups. Finally, the weight loss benefits and changes in gut microbiota and related biochemical data between the two groups will be compared.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

盲法说明

Single-blinded

入排标准

年龄范围
20 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

Body weight loss/fat mass loss

时间窗: 2 weeks to 2 months

次要结局

  • microbiota change(2 months)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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