NCT02621502已完成不适用
Pilot Study to Evaluate the Glycemic Index, and the Satiating Effect Using Different Quinoa Varieties in a Group of Healthy Overweight Subjects
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Glycemic index
研究概览
简要总结
The purpose of this study is to to assess the glycemic index and the satiating properties of different Quinoa varieties, using a Visual Analogue Scale in a sample of healthy overweight subjects.
详细描述
Pilot study to evaluate the glycemic index, and the satiating effect using different Quinoa varieties in a group of healthy overweight subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Double (Participant, Investigator)
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
- •Men and women from 18 to 65 years old.
- •Body mass index (BMI) ≥25 and <30 kg/m
- •Adequate cultural level and understanding for the clinical trial.
- •Signed informed consent
排除标准
- •Individuals with BMI ≥30 or <25 kg/m2
- •Vegetarians or individuals with a fiber intake ≥30 g/day
- •Individuals diagnosed with Diabetes Mellitus
- •Individuals with dyslipidemia on pharmacological treatment
- •Individuals with hypertension on pharmacological treatment
- •Smokers or heavy drinking individuals (>2-3 servings/day in men and > 1 serving/day in women (1 serving=1 glass of wine or 1 bottle of beer))
- •Individuals with large weight fluctuations or who have undergone in recent months a weight loss diet
- •Individuals with gastrointestinal diseases that affect the digestion or the absorption of nutrients
- •Individuals receiving at least the preceding 2 months a pharmacological treatment that modifies the lipid profile (for example, statins, fibrates, diuretics, corticosteroids, oral antidiabetic medications)
- •Pregnant or breastfeeding women
- •Women with menstrual irregularities (absence of menstrual cycle at least 2 months prior)
- •Individuals with intense physical activity
结局指标
主要结局
Glycemic index
时间窗: 0, 15, 30, 45, 60, 90, 120 min
The glycemic index is calculated with the incremental area under the curve of the glycemic response 7 time points ( 0 , 15 , 30, 45 , 60, 90 , 120 min) to 50 g intake carbohydrate food test food and reference
次要结局
- Glucose metabolism related parameters(day 1, 8, 15, 22, 29)
- satiety hunger assessment (visual analogue scale)(just before taking the product, just after taking the product, 30, 60 , 90, 120, 180, 240 min and 260 min after taking the product))
- Weight(day 1, 8, 15, 22, 29)
- Adverse effects(day 1, 8, 15, 22, 29)
- Blood hormonal markers(just before taking the product, 15, 30, 45, 60, 90 and 120 min after consuming the product)
- height(day 1, 8, 15, 22, 29)
- waist circumference(day 1, 8, 15, 22, 29)
- BMI(day 1, 8, 15, 22, 29)
研究者
研究点 (2)
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