A Randomized, Open Label, Cross Over, Single Centric, Accessor Blinded, Clinical Study to determine the Glycemic Index & Glycemic response of test products in Healthy Indian Adult Participants.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
研究概览
简要总结
This is a randomized, open label, cross over, single centric, accessor blinded clinical study to determine the Glycemic Index & Glycemic response of test product in Healthy Indian Adult Participants.
Each participant will receive 5 treatments consisting of the reference product administered on 3 different occasions and 2 administration of test product (One product with water for GI and other product with warm toned milk for GR) as per the randomization schedule.
Screening Visit (Within 15 Days)
Visit 01: Enrolment Visit and Admission Day (Day 00)
1st Product Administration (Day 01)
Visit 02: Admission Day (Day 03)
2nd Product Administration (Day 04)
Visit 03: Admission Day (Day 06)
3rd Product Administration (Day 07)
Visit 04: Enrolment Visit and Admission Day (Day 09)
4th Product Administration (Day 10)
Visit 05: Admission Day (Day 12)
5th Product Administration (Day 13)
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.
GI/GR score will be calculated by the formula:
Satiety (in terms of feeling of hunger, fullness, satisfaction and desire to eat) will be assessed using a Visual Analogue Scale (VAS) at predetermined timepoints
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
- •Participants having fasting blood glucose levels less than 100 mg/dL.
- •Participants having HbA1c level less than 5.7 percentage.
- •Participants who can understand and provide written informed consent to participate in the study.
- •Participants who are willing to refrain from vigorous physical exercise during the study period.
排除标准
- •Participants with any known food allergy or intolerance to any food or beverages.
- •Participants who are taking any medication for past one week including home remedies for diabetes or ayurvedic medications or any plant extracts.
- •Pre-diabetic participants with HbA1c level of 5.7% to 6.4% and diabetic participants with HbA1c level of 6.5% or higher.
- •Participants with recent history of dehydration from diarrhoea, vomiting or any other reason within a period of 24 hours prior to the study.
- •Participants who have participated in any clinical trial within the past 90 days with blood loss more than 450 ml.
- •Participants 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.
- •Participants having history of Hepatitis B or C virus.
研究者
Dr Simran Sethi
Cliantha Research