NCT02571114已完成不适用
A Randomized, Controlled Study to Examine the Glycemic and Metabolic Responses of Frozen Yogurt Containing Saskatoon Berry Powder in Healthy Males and Females
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Serum glucose
研究概览
简要总结
A single site, blinded, randomized, controlled study designed to examine the glycemic and metabolic response of frozen yogurt containing Saskatoon berry powder in healthy males and females.
详细描述
A single site, blinded, randomized, controlled study designed to examine the glycemic and metabolic response of frozen yogurt containing Saskatoon berry powder in healthy males and females. Eligible participants will be asked to attend 4 in-person clinic visits for comparative testing of the frozen yogurt and frozen yogurt containing Saskatoon berry powder versus white bread. Separate visits for screening and for a fasting blood sample will also be requested (total of 6 visits).
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male, or non-pregnant, non-lactating female, ≥18 and ≤35 years;
- •Normal blood lipid profile, creatinine <1.5× upper limit of normal (ULN) where the normal range is ≥7 units/L and ≤56 units/L, alanine aminotransferase (ALT) <2× ULN where the normal range is ≥0.7 mg/dL and ≤1.3 mg/dL, and glycated hemoglobin <6%;
- •Blood pressure <140/90
- •Body mass index (BMI) ≥20 and <30;
- •Stable regime for the past 3 months if taking vitamin and mineral/dietary/ herbal supplements;
- •Agree not to eat Saskatoon berries or foods containing Saskatoon berries while participating in this study;
- •Willing to comply with the protocol requirements;
- •Willing to provide informed consent.
排除标准
- •Not able to consume yogurt or allergies to Saskatoon berries or ingredients in yogurt or bread;
- •Presence of a clinically diagnosed disease affecting the circulatory, respiratory, immune, skeletal, urinary, muscular, endocrine, digestive, nervous or reproductive system that requires medical treatment;
- •Taking any prescribed medication in the last 3 months or supplements that affect gastrointestinal function in the last 3 months;
- •Weight loss of ≥3 kg of body weight within the 6 months prior to enrolling in the study;
- •Current (within the last month) bacterial, viral or fungal infection, or over-the-counter medication within the past 72 hours;
- •Unable to obtain blood samples at the screening or the first study visit.
结局指标
主要结局
Serum glucose
时间窗: 180 min
glucometer readings of serum glucose at intervals after consumption of study foods
次要结局
- serum insulin(180 min)
- metabolomics(180 min)
研究者
研究点 (2)
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