SNACKing Study: Effects of Snacking on the Gastrointestinal Microbiota and Metabolism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Changes in gastrointestinal microbial-derived metabolite concentrations
研究概览
简要总结
The proposed work will investigate the effect of almond consumption as a snack on human gastrointestinal microbiota and on metabolic health.
详细描述
This study is a randomized, controlled, investigator-blinded, parallel arm design with two treatment conditions. There will be a phone screening, in person pre-intervention testing, a one-week baseline period devoid of all nuts and seeds followed by a 12-week intervention period, and a post-testing appointment. Participants will be randomized to consume almonds or isocaloric snack for 12 weeks. Participants will provide stool samples during baseline testing and during the 12th week of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males & Females
- •30-60 years of age
- •BMI 25-34.9 kg/m^2
- •Ability to drop off fecal sample within 15 minutes of defecation
排除标准
- •Physician diagnosed metabolic or gastrointestinal diseases
- •Fasting blood glucose >126 mg/dL
- •Blood pressure >160/100 mm Hg
- •Elevation in serum transaminases (i.e. >3 times the upper limit of normal)
- •Evidence of liver disease, including primary biliary cirrhosis or gallbladder disease, constipation
- •Currently taking lipid-lowering medications, oral hypoglycemic agents, or insulin, or medications known to impact bowel function.
- •Pregnant, breastfeeding or postmenopausal
- •Smoker, tobacco use
- •Allergic to nuts
- •Consume > 2 alcoholic beverages/day
- •Abuse drugs
- •Have had > 5% weight change in the past month or > 10% change in the past year
- •Have taken antibiotics during the previous 2 months
- •Unable to consume the experimental treatments (almonds or pretzels)
- •Bariatric surgery
- •Gallbladder removal
- •Allergic to lidocaine or other topical anesthetics
结局指标
主要结局
Changes in gastrointestinal microbial-derived metabolite concentrations
时间窗: Baseline & 12-week mark
Determine the impact of daily consumption of almonds on the concentration of microbial-derived metabolites compared to control (pretzels) by using gas-liquid chromatography. These metabolites include butyrate and secondary bile acids.
Changes in abundance of fecal Roseburia spp
时间窗: Baseline & 12-week mark
Determine the impact of daily consumption of almonds on the abundance of Roseburia spp. compared to control (pretzels) by using quantitative real-time PCR.
Changes in abundance of fecal Butyryl CoA: Acetate CoA transferase
时间窗: Baseline & 12-week mark
Determine the impact of daily consumption of almonds on the abundance of Butyryl CoA: Acetate CoA transferase gene compared to control (pretzels) by using quantitative real-time PCR.
Changes in gastrointestinal microbiota composition
时间窗: Baseline & 12-week mark
Determine the impact of daily consumption of almonds on the gastrointestinal microbiota compared to control (pretzels) by sequencing the V4 region of the 16S rRNA gene in fecal samples.
次要结局
- Changes in glycemic control.(Baseline & 12-week mark)
- Changes in secondary measures of gastrointestinal health.(Baseline & 12-week mark)
- Changes in liver fat(Baseline & 12-week mark)