NCT04523155已完成不适用
Effect of Medically-tailored Meal Delivery Service on Changes in Hemoglobin A1c (HbA1c) in Patients With Diabetes: A Randomized, Crossover Clinical Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Change in Glucose Metabolism
研究概览
简要总结
The purpose of this study is to evaluate the effect of medically-tailored meal delivery (10 meals per week for 3 months) on glycemic control in diabetic patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult men and women with non-insulin dependent diabetes.
- •Ages 25 to 75 years.
- •Fasting blood sugar of greater than 140 mg/dl, on no oral hypoglycemic agents and a hemoglobin A1C less than 13%.
- •Stabilized patients on oral hypoglycemic agents for one month or longer prior to starting the study and a hemoglobin A1C between 7.5% - 13%.
排除标准
- •Insulin use.
- •Substance abuse.
- •Any documented medical problem that would inhibit full participation in the study.
- •BMI less than 25 or great than
- •Vegans or Vegetarians
- •Individuals with food allergies.
- •Individuals currently on a commercial weight loss or diet program.
研究组 & 干预措施
Treatment Sequence AB
Experimental
Participants randomized to sequence AB will receive 3 months of meals, followed by a 3 month washout period and a 3 month intervention period with no meals.
干预措施: Medically tailored meals (Dietary Supplement)
Treatment Sequence BA
Experimental
Participants randomized to sequence BA will receive 3 months of no meals followed by a 3 month washout period and a 3 month intervention period with meals.
干预措施: Medically tailored meals (Dietary Supplement)
结局指标
主要结局
Change in Glucose Metabolism
时间窗: Baseline, 3 monts
Measured by HbA1c levels in standard chemistry in blood
次要结局
- Change in Triglycerides(Baseline, 3 months)
- Change in Weight(Baseline, 3 months)
- Change in Low Density Lipoprotein (LDL)(Baseline, 3 months)
- Change in High Density lipoprotein (HDL)(Baseline, 3 months)
- Change in Blood Pressure(Baseline, 3 months)
研究者
Bryan Farford
Principal Investigator
Mayo Clinic
研究点 (2)
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