A Randomized, Open Label, Cross Over, Single Centric Clinical Study to determine the Glycemic Index and Glycemic Response of two different flavors - Complan VieMax Vanilla and Complan VieMax Chocolate Drink in Healthy Indian Adult Subjects.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 1) To determine the glycemic index of test products (when consumed with water), in healthy subjects.
研究概览
简要总结
This is a randomized, open label, cross over, single centric clinical study to determine the Glycemic Index and Glycemic Response of two different flavors - Complan VieMax Vanilla and Complan VieMax Chocolate drink in healthy Indian adult subjects.
Each subject will receive 7 treatments consisting of the reference product administered on 3 different occasions and 4 administration of test products (both variants in water for GI and both variants in warm toned milk for GR) as per the randomization schedule.
- Visit 01: Screening Visit (Within 30 Days)
- Visit 02: Enrolment Visit and Admission Day (Day 01) + 1st Product Administration (Day 02)
- Visit 03: Admission Day (Day 04) + 2nd Product Administration (Day 05)
- Visit 04: Admission Day (Day 07) + 3rd Product Administration (Day 08)
- Visit 05: Admission Day (Day 10) + 4th Product Administration (Day 11)
- Visit 06: Admission Day (Day 13) + 5th Product Administration (Day 14)
- Visit 07: Admission Day (Day 16) + 6th Product Administration (Day 17)
- Visit 08: Admission Day (Day 19) + 7th Product Administration (Day 20)
There will be a washout period of 02 days between doses.
Incremental area under the blood glucose response curve IAUC (0-120 mins), for reference and the test products will be determined for the assessment of glycemic index and glycemic response.
GI / GR score will be calculated by the formula: (Blood glucose IAUC value for test products / Average IAUC value of standard glucose) x 100
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects having fasting blood glucose levels more than 100 mg/dL.
- •Subjects having HbA1c level more than 5.7% 3) Subjects with Body Mass Index of 18.5 to 22.9 kg/m2 (both inclusive).
- •Subjects who can understand and provide written informed consent to participate in the study.
- •Subjects who are willing to refrain from vigorous physical exercise during the study period.
排除标准
- •Subjects with any known food allergy or intolerance to any food or beverages.
- •Subjects who are taking any medication for past one week including home remedies for diabetes or ayurvedic medications or any plant extracts.
- •Pre-diabetic subjects with HbA1c level of 5.7% to 6.4% and diabetic subjects with HbA1c level of 6.5% or higher.
- •Subjects with recent history of dehydration from diarrhoea, vomiting or any other reason within a period of 24 hours prior to the study.
- •Subjects who have participated in any clinical trial within the past 90 days with blood loss more than 450 ml.
- •Subjects who are on an unusual diet, special diet, for whatever reason e.g., high protein diet, low sodium diet, for two weeks prior to receiving any reference/test product and throughout subject’s participation in the study.
- •Subjects having history of Hepatitis B or C virus.
结局指标
主要结局
1) To determine the glycemic index of test products (when consumed with water), in healthy subjects.
时间窗: 15 mins prior to product administration and 0, 15, 30, 45, 60, 90 and 120 minutes post product administration on each product administration day.
2) To determine the glycemic response of test products (when consumed with milk), in healthy subjects.
时间窗: 15 mins prior to product administration and 0, 15, 30, 45, 60, 90 and 120 minutes post product administration on each product administration day.
次要结局
- Assessment of Satiety level using an equilateral 7-point rating scale(15 mins prior to product administration and 0, 30, 60, 90 and 120 minutes post product administration on each product administration day.)
研究者
Dr Simran Sethi
Cliantha Research