Pistachios Blood Sugar Control, Heart and Gut Health
关键词
抽象
描述
A two-period randomized crossover trial will be conducted. Participants will be randomized to receive each treatment for 12 weeks followed by a minimum 4-week wash-out period. During the pistachio treatment, participants will consume two ounces per day (57 g) of pistachios as an evening snack. During the control phase subjects will be given advice to consume 1-2 exchanges of carbohydrate as an evening snack, which is consistent with usual care. Markers of glycemic control, cardiovascular risk factors and gut health will be assessed at the beginning and the end of each treatment period.
日期
| 最后验证: | 08/31/2019 |
| 首次提交: | 08/11/2019 |
| 提交的预估入学人数: | 08/12/2019 |
| 首次发布: | 08/13/2019 |
| 上次提交的更新: | 09/16/2019 |
| 最近更新发布: | 09/17/2019 |
| 实际学习开始日期: | 09/08/2019 |
| 预计主要完成日期: | 05/29/2021 |
| 预计完成日期: | 05/29/2021 |
状况或疾病
干预/治疗
Drug: Evening Pistachio Consumption
Other: Usual care
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Active Comparator: Evening Pistachio Consumption Participants will consume two ounces per day (57 g) of pistachios as an evening snack (i.e., after dinner and before sleep). | Drug: Evening Pistachio Consumption Unsalted pistachios |
| Active Comparator: Usual care Advice to consume a snack that contains 1-2 exchanges (15-30 g of carbohydrate) as an evening snack - this is consistent with the current standard of care for people with impaired fasting glucose. | Other: Usual care Advice and resources will be provided |
资格标准
| 有资格学习的年龄 | 30 Years 至 30 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - BMI ≥25 and ≤45 kg/m2 - Fasting plasma glucose 100 - 125 mg/dL - non-Smoking Exclusion Criteria: - Diagnosed diabetes or fasting glucose >126 mg/dl - Systolic blood pressure >160mmHg or diastolic blood pressure >100mmHg) - Prescribed anti-hypertensive, lipid lowering or glucose lowering drugs - Established cardiovascular disease, stroke, diabetes, liver, kidney or autoimmune disease or inflammatory conditions - Use of supplements (psyllium, fish oil, soy lecithin, phytoestrogens) and botanicals and not willing to cease for the duration of the study - Women who are pregnant, lactating, planning to become pregnant or have given birth in the past year - Weight loss of >=10% of body weight within the 6 months prior to enrolling in the study - Smoking or use of any tobacco products - Allergy/intolerance/sensitive to pistachios - Consumption of >14 alcoholic drinks/week - Shift-workers and those who cannot consume a snack in the evening |
结果
主要结果指标
1. Fasting plasma glucose concentration [12 weeks]
次要成果指标
1. HbA1c [12 weeks]
2. Serum insulin concentration [12 weeks]
3. Peripheral systolic and diastolic blood pressure [12 weeks]
4. Central systolic and diastolic blood pressure [12 weeks]
5. Carotid-femoral pulse wave velocity [12 weeks]
6. Augmentation Index (%) [12 weeks]
7. LDL cholesterol concentration [12 weeks]
8. HDL cholesterol concentration [12 weeks]
9. Total cholesterol concentration [12 weeks]
10. Triglyceride concentration [12 weeks]
11. HOMA-IR [12 weeks]
12. waist circumference [12 weeks]
13. body weight [12 weeks]
14. Diet quality: Healthy Eating Index 2015 [12 weeks]
15. Change in the composition of the gut microbiome [12 weeks]
