Investigating the Effects of Avocado Intake on Metabolism and Cognition: A Systems Approach
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Abdominal obesity
研究概览
简要总结
The proposed work will investigate the effects of avocados on abdominal obesity and glycemic control among overweight/obese adults.
详细描述
The proposed work will investigate the effects of avocados on abdominal obesity and glycemic control among overweight/obese adults. Further, changes in GI microbiota composition and cognitive function will be assessed to comprehensively understand systemic benefits of avocado consumption on gut and brain function. This research study has two aims: 1) To determine the effects of regular avocado intake on metabolic syndrome risk factors, specifically, abdominal obesity and glycemic control, among overweight and obese adults; and 2) to investigate the implications of avocado intake on measures of GI microbiota composition and cognitive function.
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
- None
入排标准
- 年龄范围
- 25 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females
- •Between the ages of 25-45 years at the time of consent
- •Body mass index ≥27.5kg/m2
- •Normal or corrected-to-normal vision based on the minimal 20/20 standard in order to complete the cognitive task (below 20/20 vision).
- •Ability to drop-off fecal sample within 15 minutes of defecation
排除标准
- •Current pregnancy or lactation
- •Tobacco use
- •Avocado allergy or intolerance
- •Food allergies, lactose intolerance
- •Latex allergy
- •Prior diagnosis of metabolic and 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.)
- •Prior diagnosis of cognitive or physical disability, including ADHD, severe asthma, epilepsy, chronic kidney disease, and dependence upon a wheelchair/walking
- •Use of any anti-psychotic, anti-depressant, anti-anxiety, or ADD/ADHD medications
- •Use of medications that alter normal bowel function and metabolism (e.g., recent antibiotic use, laxatives, enemas, anti-diarrheal agents, narcotics, antacids, antispasmodics, diuretics, anticonvulsants).
- •High BMI that is not representative of being overweight or obese (e.g. resistance trained individuals, football players)
- •Prior malabsorptive bariatric surgery (i.e. gastric bypass, sleeve gastrectomy) or restrictive bariatric surgery (i.e. adjustable gastric band) within the past 2 years
结局指标
主要结局
Abdominal obesity
时间窗: Baseline, 4 weeks, 8 weeks, 12 weeks
Changes to abdominal and whole body composition including visceral and subcutaneous adipose tissue will be estimated by DEXA.
Insulin Resistance
时间窗: Baseline, 4 weeks, 8 weeks, 12 weeks
Insulin resistance will be evaluated using the Homeostasis Assessment Model (HOMA) index.
Glycemic Control
时间窗: Baseline, 4 weeks, 8 weeks,12 weeks
Glycemic control will be assessed using oral glucose tolerance tests and hemoglobin A1c.
Insulin Sensitivity
时间窗: Baseline, 12 weeks
Insulin sensitivity will be assessed using the insulinogenic index, Stumvoll Metabolic Clearance Rate, Oral Glucose Insulin Sensitivity, and the Matsuda Index.
次要结局
- Gastrointestinal Microbiota Composition and Short Chain Fatty Acids(Baseline, 4 weeks, 8 weeks, 12 weeks)
- Inflammatory Markers(Baseline, 12 weeks)
- Blood Lipid Panel(Baseline, 12 weeks)
- Sleep and Fatigue(Baseline, 12 weeks)
- Physical Activity(Baseline, 12 weeks)
- Cognitive Function(Baseline, 4 weeks, 8 weeks, 12 weeks)
- Retinal Lutein(Baseline, 4 weeks, 8 weeks, 12 weeks)
- Serum Lutein(Baseline, 12 weeks)
- Resting Energy Expenditure(Baseline, 12 weeks)
- DNA Analyses(Baseline)
- Dietary Intake(Baseline, 4 weeks, 8 weeks, 12 weeks)
- Blood Pressure(Baseline, 12 weeks)
- Neuroelectric Assessment(Baseline, 4 weeks, 8 weeks, 12 weeks)
- Liver Enzymes(Baseline, 12 weeks)