NCT01850134撤回不适用
Evaluation of a Nutritional Supplement for People With Type 2 Diabetes (T2DM).
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Hunger
研究概览
简要总结
The objective of this trial is to evaluate a nutritional supplement for people with Diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects will be eligible for the study if they meet all of the following inclusion criteria:
- •Diagnosis of Type 2 Diabetes.
- •Age between 18 and 75 years.
- •HbA1c > 6.0 but ≤ 8.5
- •If female and of childbearing potential , subject is non-pregnant, non- lactating, at least 6 weeks postpartum and agrees to practice birth control throughout study duration.
- •BMI > 18.5 kg/m2 and < 40.0 kg/m
- •Chronic medication dosage must be stable for at least two months prior to Screening Visit.
- •Subject states that they are a habitual consumer of a morning meal.
排除标准
- •Subjects will be excluded from the study if they meet any of the following criteria:
- •Use of exogenous insulin or GLP-1 agonists for glucose control.
- •Diagnosis of Type 1 diabetes.
- •History of diabetic ketoacidosis.
- •Current infection (requiring medication or hospitalization), has received corticosteroid treatment in the last 3 months, or has had surgery or received antibiotics in the last 3 weeks.
- •Active malignancy.
- •Significant cardiovascular event < 12 weeks prior to study entry.
- •End stage organ failure or status post organ transplant.
- •Active metabolic, hepatic, or gastrointestinal disease.
- •Chronic, contagious, infectious disease.
- •Currently taking herbals, dietary supplements, or medications (other than antihyperglycemic medications) that could profoundly affect blood glucose.
- •History of fainting or other adverse reactions in response to blood collection.
- •Clotting or bleeding disorders.
- •Allergy or intolerance to study product ingredient.
研究组 & 干预措施
Control Study Product
Placebo Comparator
1 serving of control beverage.
干预措施: Control Study Product (Other)
Experimental Study Product
Experimental
1 serving of a nutritional supplement for people with diabetes.
干预措施: Experimental Study Product (Other)
结局指标
主要结局
Hunger
时间窗: Treatment Visit 1 and Treatment Visit 2
An appetite questionnaire evaluating change from baseline during each study visit.
次要结局
- Prospective Consumption(Treatment Visit 1 and Treatment Visit 2)
- Fullness(Treatment Visit 1 and Treatment Visit 2)
- Desire to Eat(Treatment Visit 1 and Treatment Visit 2)
研究者
研究点 (2)
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