Persea Americana for Total Health (PATH ) Study
关键词
抽象
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.
日期
| 最后验证: | 09/30/2016 |
| 首次提交: | 04/10/2016 |
| 提交的预估入学人数: | 04/10/2016 |
| 首次发布: | 04/14/2016 |
| 上次提交的更新: | 10/13/2016 |
| 最近更新发布: | 10/16/2016 |
| 实际学习开始日期: | 01/31/2016 |
| 预计主要完成日期: | 01/31/2019 |
| 预计完成日期: | 01/31/2019 |
状况或疾病
干预/治疗
Other: Intervention Meal
Other: Control Meal
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: Intervention Meal Intervention meals will contain 1 large avocado and be consumed daily for 12 weeks. | Other: Intervention Meal The intervention meals will contain 1 large avocado. |
| Placebo Comparator: Control Meal Control meals will be isocaloric to the intervention meals but without avocado. They will also be consumed daily for 12 weeks. | Other: Control Meal The control meals will be isocaloric to the intervention meals but will not contain avocado. |
资格标准
| 有资格学习的年龄 | 25 Years 至 25 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
结果
主要结果指标
1. Abdominal obesity [Baseline, 4 weeks, 8 weeks, 12 weeks]
2. Glycemic Control [Baseline, 4 weeks, 8 weeks,12 weeks]
3. Insulin Resistance [Baseline, 4 weeks, 8 weeks, 12 weeks]
4. Insulin Sensitivity [Baseline, 12 weeks]
次要成果指标
1. Gastrointestinal Microbiota Composition and Short Chain Fatty Acids [Baseline, 4 weeks, 8 weeks, 12 weeks]
2. Cognitive Function [Baseline, 4 weeks, 8 weeks, 12 weeks]
3. Retinal Lutein [Baseline, 4 weeks, 8 weeks, 12 weeks]
4. Serum Lutein [Baseline, 12 weeks]
5. Blood Lipid Panel [Baseline, 12 weeks]
6. Resting Energy Expenditure [Baseline, 12 weeks]
7. Neuroelectric Assessment [Baseline, 4 weeks, 8 weeks, 12 weeks]
8. DNA Analyses [Baseline]
9. Dietary Intake [Baseline, 4 weeks, 8 weeks, 12 weeks]
10. Sleep and Fatigue [Baseline, 12 weeks]
11. Physical Activity [Baseline, 12 weeks]
12. Blood Pressure [Baseline, 12 weeks]
13. Liver Enzymes [Baseline, 12 weeks]
14. Inflammatory Markers [Baseline, 12 weeks]
