Pilot Study to Evaluate the Glycemic Index, and the Satiating Effect Using Different Quinoa Varieties in a Group of Healthy Overweight Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 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
研究组 & 干预措施
Quinoa variety 1
1 dose of Quinoa Variety 1 orally. The product is provided in a mix-pack together with water (100mL). This flexible container is capable of maintaining separate purified water (100 mL) and the experimental powder product in the same package. Both products can be easily mixed by breaking the inner seal. Volunteers had a maximum of 10 minutes to consume the product.
干预措施: Quinoa variety 1 (Dietary Supplement)
Quinoa variety 2
1 dose of Quinoa Variety 2 orally. The product is provided in a mix-pack together with water (100mL). This flexible container is capable of maintaining separate purified water (100 mL) and the experimental powder product in the same package. Both products can be easily mixed by breaking the inner seal. Volunteers had a maximum of 10 minutes to consume the product.
干预措施: Quinoa variety 2 (Dietary Supplement)
Quinoa variety 3
1 dose of Quinoa Variety 3 orally. The product is provided in a mix-pack together with water (100mL). This flexible container is capable of maintaining separate purified water (100 mL) and the experimental powder product in the same package. Both products can be easily mixed by breaking the inner seal. Volunteers had a maximum of 10 minutes to consume the product.
干预措施: Quinoa variety 3 (Dietary Supplement)
Quinoa variety 4
1 dose of Quinoa Variety 4 orally. The product is provided in a mix-pack together with water (100mL). This flexible container is capable of maintaining separate purified water (100 mL) and the experimental powder product in the same package. Both products can be easily mixed by breaking the inner seal. Volunteers had a maximum of 10 minutes to consume the product.
干预措施: Quinoa variety 4 (Dietary Supplement)
Anhydrous Glucose
1 dose of Anhydrous Glucose orally. . The product is provided in a mix-pack together with water (100mL). This flexible container is capable of maintaining separate purified water (100 mL) and the control powder product in the same package. Both products can be easily mixed by breaking the inner seal. Volunteers had a maximum of 10 minutes to consume the product.
干预措施: Anhydrous Glucose (Dietary Supplement)
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
- height(day 1, 8, 15, 22, 29)
- waist circumference(day 1, 8, 15, 22, 29)
- BMI(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)
- 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)