适用于超重或肥胖人群的新一代合生元
超重或肥胖个体补充下一代合生元：三盲随机对照临床试验
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.
研究概览
详细说明
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.
Psychological questionnaires such as the Beck Anxiety and the Beck Depression Inventories, as well as the RED-9 questionnaire to respectively measure anxiety, depression, and food cravings, will be applied before and after the symbiotic intervention.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Texas
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Fort Worth、Texas、美国、76129
- Texas Christian University, Rickel Building
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- be between 18-50 years of age
- have a BMI between 25.0-40.0
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Synbiotic Group
They will receive a 3-day antibiotic (Vancomycin 500 mg/3 times/day), followed by a 3-month symbiotic. The synbiotic that will be used in this trial contains the oligosaccharide-degrading probiotics, Akkermansia muciniphila and Bifidobacterium infantis; butyrate producers such as Clostridium beijerinckii, Anaerobutyricum hallii, and Clostridium butyricum; and chicory-derived inulin, a prebiotic dietary fiber. |
WBF-038: Noninfectious and nonhazardous lyophilized commensal bacteria (probiotics). Contains no genetically modified organisms (GMOs) and contains no animal ingredients or by-products, and were originally isolated from human sources. The (probiotic) strains are grown in a FDA registered food facility, adhering to Good Manufacturing Practice (GMP) conditions. Probiotic Ingredients: Clostridium butyricum WBSTR-0006, Clostridium beijerinckii WB-STR-0005, Anaerobutyricum hallii WB-STR-0008, Akkermansia muciniphila WBSTR-0001, and Bifidobacterium infantis The product also contains: Chicory inulin and oligofructose (prebiotic fiber), hypromellose (vegetarian capsule), fruit & vegetable juice (coloring agent), magnesium stearate and silica (flow agent for encapsulation)
其他名称：
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安慰剂比较：Placebo Group
They will receive a 3-day antibiotic (Vancomycin 500 mg/3 times/day), followed by a 3-month placebo. |
Ingredients: Chicory inulin and oligofructose (prebiotic fiber, hypromellose (vegetarian capsule), fruit & vegetable juice (coloring agent), magnesium stearate and silica (flow agent for encapsulation).
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Total Body Fat Mass through DXA (percentage)
大体时间：These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
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We will measure body fat mass by using DXA analysis. |
These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
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Total Body Fat Mass through BodPod (percentage)
大体时间：These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
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We will measure body fat mass by using BodPod analysis. |
These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
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Fat Mass to Height (kg/m2)
大体时间：These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
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We will measure body fat mass by using DXA analysis. |
These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
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Fat Mass (kg)
大体时间：These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
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We will measure body fat mass by using BodPod analysis. |
These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
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Body Lean Mass to Height (kg/m2)
大体时间：These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
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We will measure body lean mass by using DXA analysis. |
These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
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Fat Free Mass (%)
大体时间：These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
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We will measure body lean mass by using BodPod analysis. |
These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
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Fat Free Mass (Kg)
大体时间：These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
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We will measure body lean mass by using BodPod analysis. |
These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
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Visceral Fat Volume (cm3)
大体时间：These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
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We will measure body visceral mass by using DXA and BodPod analysis. |
These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
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Visceral Fat Mass (grams)
大体时间：These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
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We will measure body visceral mass by using DXA and BodPod analysis. |
These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
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Fasting Glucose (mg/dL)
大体时间：Blood samples will be taken before the antibiotic, before the synbiotic/placebo, and right after the 3-month synbiotic/placebo intervention.
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We will measure fasting glucose after a 12h fast. |
Blood samples will be taken before the antibiotic, before the synbiotic/placebo, and right after the 3-month synbiotic/placebo intervention.
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Fasting Insulin (mIU/L)
大体时间：Blood samples will be taken before the antibiotic, before the synbiotic/placebo, and right after the 3-month synbiotic/placebo intervention.
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We will measure fasting insulin after a 12h fast. |
Blood samples will be taken before the antibiotic, before the synbiotic/placebo, and right after the 3-month synbiotic/placebo intervention.
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HbA1c (%)
大体时间：Blood samples will be taken before the antibiotic, before the synbiotic/placebo, and right after the 3-month synbiotic/placebo intervention.
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We will measure HbA1c after a 12h fast. |
Blood samples will be taken before the antibiotic, before the synbiotic/placebo, and right after the 3-month synbiotic/placebo intervention.
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Anxiety (number in 0-63 scale)
大体时间：These questionnaires will be applied right before and right after the 3-month synbiotic/placebo intervention.
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We will measure anxiety by using the Beck Anxiety inventory. The higher the number, the higher the anxiety levels. |
These questionnaires will be applied right before and right after the 3-month synbiotic/placebo intervention.
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Depression (number in 0-63 scale)
大体时间：These questionnaires will be applied right before and right after the 3-month synbiotic/placebo intervention.
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We will measure depression by using the Beck Depression inventory. The higher the number, the higher the depression. |
These questionnaires will be applied right before and right after the 3-month synbiotic/placebo intervention.
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Food cravings (number in 0-52 scale)
大体时间：These questionnaires will be applied right before and right after the 3-month synbiotic/placebo intervention.
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We will measure food cravings by using the Reward-based Eating Drive questionnaire (RED-9). The higher the number, the higher the cravings. |
These questionnaires will be applied right before and right after the 3-month synbiotic/placebo intervention.
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Gut Microbial Composition (depending on funding availability at the time of analysis)
大体时间：Stool samples will be collected right before the antibiotic, right before the synbiotic/placebo intervention, and right after the 3-month synbiotic/placebo intervention.
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We plan to measure gut microbial composition by performing whole metagenome sequencing previously stored in Zymo stool collection tubes. |
Stool samples will be collected right before the antibiotic, right before the synbiotic/placebo intervention, and right after the 3-month synbiotic/placebo intervention.
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Blood Microbial Composition (depending on funding availability at the time of analysis)
大体时间：Blood samples will be collected right before the antibiotic, right before the synbiotic/placebo intervention, and right after the 3-month synbiotic/placebo intervention.
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We plan to measure blood microbial composition by performing 16S rRNA in blood samples previously stored in Zymo blood collection tubes. |
Blood samples will be collected right before the antibiotic, right before the synbiotic/placebo intervention, and right after the 3-month synbiotic/placebo intervention.
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Body Weight (kg)
大体时间：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.
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Body weight will be measured with a calibrated scale. |
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.
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Body Height (meters)
大体时间：Measurement will take place at the first visit.
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Body height will be measured with a stadiometer. |
Measurement will take place at the first visit.
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合作者和调查者
调查人员
- 首席研究员：Elisa Marroquin, Ph.D.、Texas Christian University
出版物和有用的链接
一般刊物
- Depommier C, Everard A, Druart C, Plovier H, Van Hul M, Vieira-Silva S, Falony G, Raes J, Maiter D, Delzenne NM, de Barsy M, Loumaye A, Hermans MP, Thissen JP, de Vos WM, Cani PD. Supplementation with Akkermansia muciniphila in overweight and obese human volunteers: a proof-of-concept exploratory study. Nat Med. 2019 Jul;25(7):1096-1103. doi: 10.1038/s41591-019-0495-2. Epub 2019 Jul 1.
- Perraudeau F, McMurdie P, Bullard J, Cheng A, Cutcliffe C, Deo A, Eid J, Gines J, Iyer M, Justice N, Loo WT, Nemchek M, Schicklberger M, Souza M, Stoneburner B, Tyagi S, Kolterman O. Improvements to postprandial glucose control in subjects with type 2 diabetes: a multicenter, double blind, randomized placebo-controlled trial of a novel probiotic formulation. BMJ Open Diabetes Res Care. 2020 Jul;8(1):e001319. doi: 10.1136/bmjdrc-2020-001319.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
De-identified participant-level data can be shared only after authors and co-authors have published the material of their interest.
IPD 共享时间框架
Data will be available only after authors and co-authors have published the material of their interest.
IPD 共享访问标准
Not available at this point. Recruitment has not started.
IPD 共享支持信息类型
- 研究方案
- 树液
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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