Supplementation With a Next-Generation Synbiotic in Individuals With Overweight or Obesity: A Triple-Blinded Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Fat Free Mass (%)
研究概览
简要总结
This study plans to evaluate the effect of consuming a symbiotic (probiotic + prebiotic) for 3 months on body weight, body composition, glucose sensitivity, and psychological parameters, as well as on gut and blood microbial composition. Synbiotic consumption is preceded by a 3-day antibiotic course to help ensure the opening of new niches (houses) for the upcoming beneficial bacteria.
详细描述
This is a triple-blinded, randomized clinical trial in which participants will be allocated to one of two groups: 1) 3-day antibiotic followed by synbiotic consumption for 3 months or 2) 3-day antibiotic followed by placebo consumption for 3 months.
Blood and stool samples will be collected before the antibiotic, and before and after the symbiotic intervention in both groups.
Gut microbial composition will be analyzed through whole genome sequencing and blood microbial composition through 16S rRNA.
Glucose sensitivity will be measured through fasting glucose, fasting insulin, and HbA1c.
Body composition through DXA and BodPod will be measured before and after the symbiotic intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This is a triple-blind study. Participants, the research staff, the PI, and the biostatistician will be all blinded. A university staff person who does not belong to the research team or the funding agency but has been CITI certified and approved by the IRB will hold the key of the assignment key.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •be between 18-50 years of age
- •have a BMI between 25.0-40.0
排除标准
- •are following a vegetarian, vegan, carnivore, or keto diet
- •currently taking metformin, GLP-1 agonists, insulin, or fiber
- •have taken antiacids, laxatives, probiotics, or medication that affects your immune system in the past month
- •pregnant, planning pregnancy during the study period, or lactating
- •have a history of inflammatory bowel disease, colon cancer, or chronic polyps
- •have been diagnosed with type 1 or type 2 diabetes
- •have active cancer
- •are currently participating in a weight loss intervention (dietetic or medication)
- •have used antibiotics, antifungals, or antivirals in the past 3 months
- •have had a history of recent (within 30 days) diarrhea illness
- •have a known allergy to any component of the study product
- •have had an acute inflammatory infection or inflammatory condition in the past 4 weeks
- •have had >10% weight variation in the past 6 months
- •have had any bariatric surgery
结局指标
主要结局
Fat Free Mass (%)
时间窗: These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
We will measure body lean mass by using BodPod analysis.
Fat Mass to Height (kg/m2)
时间窗: These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
We will measure body fat mass by using DXA analysis.
Fat Mass (kg)
时间窗: These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
We will measure body fat mass by using BodPod analysis.
Body Height (meters)
时间窗: Measurement will take place at the first visit.
Body height will be measured with a stadiometer.
Fat Free Mass (Kg)
时间窗: These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
We will measure body lean mass by using BodPod analysis.
Visceral Fat Volume (cm3)
时间窗: These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
We will measure body visceral mass by using DXA and BodPod analysis.
Fasting Insulin (mIU/L)
时间窗: Blood samples will be taken before the antibiotic, before the synbiotic/placebo, and right after the 3-month synbiotic/placebo intervention.
We will measure fasting insulin after a 12h fast.
Anxiety (number in 0-63 scale)
时间窗: These questionnaires will be applied right before and right after the 3-month synbiotic/placebo intervention.
We will measure anxiety by using the Beck Anxiety inventory. The higher the number, the higher the anxiety levels.
Depression (number in 0-63 scale)
时间窗: These questionnaires will be applied right before and right after the 3-month synbiotic/placebo intervention.
We will measure depression by using the Beck Depression inventory. The higher the number, the higher the depression.
Gut Microbial Composition (depending on funding availability at the time of analysis)
时间窗: Stool samples will be collected right before the antibiotic, right before the synbiotic/placebo intervention, and right after the 3-month synbiotic/placebo intervention.
We plan to measure gut microbial composition by performing whole metagenome sequencing previously stored in Zymo stool collection tubes.
Total Body Fat Mass through DXA (percentage)
时间窗: These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
We will measure body fat mass by using DXA analysis.
Total Body Fat Mass through BodPod (percentage)
时间窗: These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
We will measure body fat mass by using BodPod analysis.
Body Lean Mass to Height (kg/m2)
时间窗: These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
We will measure body lean mass by using DXA analysis.
Visceral Fat Mass (grams)
时间窗: These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
We will measure body visceral mass by using DXA and BodPod analysis.
Fasting Glucose (mg/dL)
时间窗: Blood samples will be taken before the antibiotic, before the synbiotic/placebo, and right after the 3-month synbiotic/placebo intervention.
We will measure fasting glucose after a 12h fast.
Food cravings (number in 0-52 scale)
时间窗: These questionnaires will be applied right before and right after the 3-month synbiotic/placebo intervention.
We will measure food cravings by using the Reward-based Eating Drive questionnaire (RED-9). The higher the number, the higher the cravings.
HbA1c (%)
时间窗: Blood samples will be taken before the antibiotic, before the synbiotic/placebo, and right after the 3-month synbiotic/placebo intervention.
We will measure HbA1c after a 12h fast.
Blood Microbial Composition (depending on funding availability at the time of analysis)
时间窗: Blood samples will be collected right before the antibiotic, right before the synbiotic/placebo intervention, and right after the 3-month synbiotic/placebo intervention.
We plan to measure blood microbial composition by performing 16S rRNA in blood samples previously stored in Zymo blood collection tubes.
Body Weight (kg)
时间窗: Measurements will take place at each of the 3 visits: right before the antibiotic, right before the synbiotic/placebo, and right after the 3-month synbiotic/placebo intervention.
Body weight will be measured with a calibrated scale.
次要结局
未报告次要终点