The Effect of Walnuts on Glucose Variability in Adults With Type-2 Diabetes Mellitus: a Dose-response Metabolic Feeding Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Within-day glucose variability
研究概览
简要总结
Persons with type 2 diabetes mellitus (T2DM) have swings in their blood sugar levels that may lead to a higher risk of developing heart disease. An important part of diabetes management involves eating a diet to prevent large swings in blood sugar levels. Walnuts contain fat, protein and fiber that may reduce the swings in blood sugar. The purpose of this study is to compare the effects of a walnut-free American Diabetes Association (ADA) diet versus 2 levels of walnut-enriched ADA diets on blood sugar swings. Eighteen male and female adults with T2DM will participate in the study. Subjects will be randomized to consume an ADA diet with or without walnuts for 3 consecutive days every other week. Subjects must test their blood sugar twice daily and wear a continuous glucose monitor during the three 72-hour study periods. Subjects will be between 40 and 70 years of age and will be recruited from the surrounding community using flyers and public service announcements. Consent will take place in the Department of Nutrition at Loma Linda University by the study investigators. In total, subject participation will last 5 weeks and all meals will be provided during the 3 study periods.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults between age 40 and 70 years with type 2 diabetes
- •duration of type 2 diabetes more than 6 months but less than 10 years
- •HbA1c 6.0-8.0%
- •BMI 25-40 kg/m2
- •diet controlled or stable dose of metformin for at least 3 months
- •willing to test blood glucose with personal meter twice a day during study test days
排除标准
- •using oral hypoglycemic agents or insulin
- •history of ischemic heart disease or congestive heart failure
- •history of severe diabetic complication (neuropathy, renal failure, stroke)
- •taking medication affecting glucose levels (i.e. corticosteroids)
- •active infectious disease
- •active malignancy
- •pregnant or breast feeding woman
- •history of daily caffeine or alcohol intake
- •known allergy to nuts
- •lactose or gluten intolerance
研究组 & 干预措施
Full dose
full dose of walnuts (20% energy needs)
干预措施: Full dose (Dietary Supplement)
Half-dose
Half dose of walnuts (10% of energy needs)
干预措施: Half dose (Dietary Supplement)
Control
Walnut free meals
干预措施: Control (Dietary Supplement)
结局指标
主要结局
Within-day glucose variability
时间窗: 3 days
The primary objective is to evaluate the effect of two isocaloric walnut-enriched meal plans versus a walnut-free ADA meal plan on within-day glucose variability in adults with diabetes by assessing: a) the overall standard deviation (SD) around the sensor glucose calculated for each day and then averaged over the 3-day study periods; b) the mean amplitude of glycemic excursions (MAGE) over the 3-day study periods.
次要结局
- Glucose variability dose response(3 days)
- Dose response to between-day glycemic variability(3 days)
- Glucose levels by meal(3 days)
- Mean glucose of sensor range(3 days)
- Duration of hypoglycemia(3 days)
- Duration of hyperglycemia(3 days)
- Net glycemia at 2 hours(3 days)
- Net glycemia at 4 hours(3 days)
研究者
Michelle Wien
Assistant Professor
Loma Linda University