The Microbial and Metabolic Impact of Walnut Consumption in Adults With Obesity
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Fecal Microbial Species
研究概览
简要总结
Obesity is a growing health issue that effects the majority of adults in the United States. Prevalence of other metabolic diseases are increased in obese adults, including systemic inflammation. There is emerging evidence that the gut microbiota have a mediating role in controlling inflammation by producing butyrate when ingested fiber is fermented. Since these microbes are modifiable by diet, the investigators plan to introduce walnuts to the diets of participants with obesity because they are rich in fiber and unsaturated fatty acids. The purpose of this study is to understand the impacts of walnut consumption on the gut microbiota and the effect they have on bile acid profiles and systemic inflammation. The investigators intention is to identify how these walnut-derived molecules influence Faecalibacterium spp., a butyrate producing microbe. Increased levels of butyrate have shown to decrease secondary bile acids and decrease inflammation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants will include adults ages 25-75 years BMI of > 30 kg/m2 Ability to drop-off fecal sample within 15 minutes of defecation
排除标准
- •Walnut allergy or intolerance
- •Food allergies or intolerances
- •Prior diagnosis of metabolic or gastrointestinal disease (cardiovascular disease and type 1 or type 2 diabetes, chronic constipation, diarrhea, Crohn's disease, celiac disease, ulcerative colitis, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers, hepatitis, HIV, cancer, etc.)
- •Women that are pregnant, had a baby within the last 12 months, or lactating
- •Individuals that smoke, use tobacco, abuse drugs, or consume > 2 alcoholic beverages per day.
- •> 5% weight change in the past month or > 10% change in the past year
- •Oral antibiotics during the previous 6 weeks
- •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) or with evidence of liver disease, including primary biliary cirrhosis or gallbladder disease, constipation, are currently taking lipid-lowering medications, oral hypoglycemic agents, or insulin, or certain medications (laxatives, bile acid sequestrants, and opiates)
- •History of malabsorptive or restrictive bariatric surgeries (e.g., gastric bypass, sleeve gastrectomy, adjustable gastric band) or gall bladder removal surgery.
- •Are unable to consume the experimental meals/snacks.
- •Participants who have donated blood within the last 8 weeks
- •Recent diagnosis of anemia
- •Concurrent enrollment in another dietary, exercise, or medication study
结局指标
主要结局
Fecal Microbial Species
时间窗: Fecal samples will be collected at the end of each 3 week condition.
Abundances of fecal Faecalibacterium spp. and Roseburia spp measured using metagenomic sequencing in walnut and walnut oil vs. control.
Concentration of fecal bile acids
时间窗: Fecal samples will be collected at the end of each 3 week condition.
Fecal bile acid concentrations measured using HPLC in walnut and walnut oil vs. control
次要结局
- Fecal Microbial Metabolites(Fecal samples will be collected once at the end of each 3 week condition.)
研究者
Hannah Holscher
Associate Professor
University of Illinois at Urbana-Champaign