A Randomized, Open Label, Cross Over, Single Centric, Accessor Blinded, Clinical Study to determine the Glycemic Index of 2 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 of 2 test products 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 products 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 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 % 3) Participants with Body Mass Index of 18.5 to 22.9 kg/m2 (both inclusive).
- •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