Effects of Different Doses of Pinitol on Carbohydrate Metabolism Parameters in Healthy Subjects: a Randomized Cross-over Placebo-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Dose-response curves to assess the change in glucose and insulin concentration after an oral ingestion of different doses of pinitol with respect to the corresponding placebo
研究概览
简要总结
The purpose of this study was to assess the acute effects of increasing doses of pinitol on glucose tolerance and insulin sensitivity and to evaluate the absorption of pinitol after consumption of an oral nutritive pinitol-enriched beverage in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The inclusion criteria for all subjects were age range of 18-65 years, body mass index of 20-30 Kg/m2 and clinically normal kidney function, liver function, heart function, protein status and haematological profile.
排除标准
- •Exclusion criteria were pregnancy or lactation, alteration of carbohydrate metabolism, fasting glycaemia ≥5.55 mmol/l on at least two previous occasions, diabetes, or medication known to interfere with glucose metabolism.
研究组 & 干预措施
High dose (6.0 g of pinitol)
Each subject completed two 1-day trials separated by a 1-week interval. The subjects were randomized by alternation method to belong to the group of low, intermediate or high dose, containing 2.5, 4.0 or 6.0 g of pinitol, respectively. Each subject was newly randomized (1:1) and cross-over into one of two groups: one that received the pinitol-enriched beverage, and the other a placebo beverage. In this way, each dose and its corresponding placebo were studied in 10 normoglycaemic subjects.
干预措施: Pinitol (Dietary Supplement)
Intermediate dose (4.0 g of pinitol)
Each subject completed two 1-day trials separated by a 1-week interval. The subjects were randomized by alternation method to belong to the group of low, intermediate or high dose, containing 2.5, 4.0 or 6.0 g of pinitol, respectively. Each subject was newly randomized (1:1) and cross-over into one of two groups: one that received the pinitol-enriched beverage, and the other a placebo beverage. In this way, each dose and its corresponding placebo were studied in 10 normoglycaemic subjects.
干预措施: Pinitol (Dietary Supplement)
Low dose (2.5 g of pinitol)
Each subject completed two 1-day trials separated by a 1-week interval. The subjects were randomized by alternation method to belong to the group of low, intermediate or high dose, containing 2.5, 4.0 or 6.0 g of pinitol, respectively. Each subject was newly randomized (1:1) and cross-over into one of two groups: one that received the pinitol-enriched beverage, and the other a placebo beverage. In this way, each dose and its corresponding placebo were studied in 10 normoglycaemic subjects.
干预措施: Pinitol (Dietary Supplement)
结局指标
主要结局
Dose-response curves to assess the change in glucose and insulin concentration after an oral ingestion of different doses of pinitol with respect to the corresponding placebo
时间窗: up to 120 minutes
Each subject attended the Endocrinology Service in the morning after 12-hour overnight fasting. Blood sample was collected in vacutainer serum separator tubes at baseline (minute 0; while still fasting), 15, 30, 45, 60, 90 and 120 minutes after consumption of the tested product placebo or pinitol-enriched beverage. Glucose concentrations were measured by means of enzymatic assay in an autoanalyzer. Insulin concentrations were determined by enzyme-linked immunosorbent assay.
次要结局
- Dose-response curves to assess the change in pinitol concentration after an oral ingestion of different doses of pinitol with respect to the corresponding placebo(up to 240 minutes)
研究者
Antonio Hernández Mijares
PhD, MD
University of Valencia