Persea Americana for Total Health (PATH)-2
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Concentration of fecal bile acids
研究概览
简要总结
The goal of this clinical trial is to learn about the effects of avocado consumption on gastrointestinal health in adults with overweight and obesity. The main questions is aims to answer are:
How does avocado consumption affect the gut microbiome? How does avocado consumption affect thinking? Are there connections between the microbiome and cognition? Participants will be asked to eat provided meals with and without avocados for three 4-week periods. At the end of each 4-week period, participants will be asked to provide stool samples and complete computer games that assess thinking and memory.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 25 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must be between the ages of 25 and 74 years old
- •BMI ≥ 25 kg/m2
- •Ability to drop off fecal sample within 15 minutes of defecation
- •20/20 or corrected vision
排除标准
- •Avocado allergy or intolerance
- •Food allergies or intolerances
- •Prior diagnosis of liver or gastrointestinal disease (primary biliary cirrhosis or gallbladder disease, chronic constipation, diarrhea, Crohn's disease, celiac disease, ulcerative colitis, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers), diabetes, hepatitis, HIV, or cancer
- •Women that are pregnant, have given birth in the previous 12 months or are 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 six months
- •Oral antibiotics during the previous 6 weeks.
- •Currently taking lipid-lowering medications, oral hypoglycemic agents, or insulin.
- •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.
- •Allergic to latex
- •Concurrent enrollment in another dietary, exercise, or medication study
结局指标
主要结局
Concentration of fecal bile acids
时间窗: 4 weeks
Fecal bile acid concentrations using HPLC in avocado and active comparator vs. control,
Fecal microbial genes
时间窗: 4 weeks
Microbial genes involved in short-chain fatty acids and secondary bile acid synthesis measured using metagenomic sequencing
Fecal microbial species
时间窗: 4 weeks
Feacalibacterium spp., bacteria capable of producing SCFA and secondary bile acid synthesis measured using metagenomic sequencing
Concentration of fecal SCFA
时间窗: 4 weeks
Fecal SCFA concentrations using GC-MS in avocado and active comparator vs. control,
次要结局
- Cognitive function(4 weeks)
- Subjective gastrointestinal tolerance via questionnaire(4 week)
- Digestive health using stool records/Bristol Stool Scale(4 week)
研究者
Hannah Holscher
Associate Professor
University of Illinois at Urbana-Champaign