A Randomized, Open Label, Cross Over, Single Centric Clinical Study to determine the Glycemic Index and Glycemic Response of two different flavors - Shelcal Total Vanilla and Shelcal Total Chocolate Drink in Healthy Indian Adult Participants.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To determine the glycemic index and glycemic response of test products in healthy participants.
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 - Shelcal Total Vanilla and Shelcal Total Chocolate Drink in healthy Indian adult participants.
Each participant 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.
· 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)
· Visit 06: Admission Day (Day 15)
6th Product Administration (Day 16)
· Visit 07: Admission Day (Day 18)
7th Product Administration (Day 19)
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 using standard formula.
Satiety will be assessed using an equilateral 7-point rating scale 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
- •Healthy, adult male and non-pregnant/non-lactating female participants between the ages of 18 to 45 years both inclusive at the time of consent.
- •Participants having fasting blood glucose levels less than 100 mg/dL.
- •Participants having HbA1c level less than 5.7 % 4) Participants with Body Mass Index of 18.5 to 22.9 kg/m2 (both inclusive).
- •Participants with good general health as determined by the Investigator based on medical history and vital signs.
- •Participants who are literate and can understand and provide written informed consent to participate in the study.
- •Participants who agree to refrain from vigorous physical exercise during the study period.
排除标准
- •Participants with any known food allergies or intolerance to any food or beverages.
- •Participants who are taking any medication for the past 4 weeks 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.
- •Participant with recent history of dehydration from diarrhea, vomiting or any other reason within a period of 24 hours prior to study.
- •Participants who are on an unusual diet, special diet, for whatever reason e.g., high protein diet, low sodium diet, intermittent fasting for two weeks prior to receiving any reference/test product and throughout participant’s participation in the study.
- •Participants who have tested positive for HIV test.
- •Participants with history of Hepatitis B or C virus.
结局指标
主要结局
To determine the glycemic index and glycemic response of test products in healthy participants.
时间窗: 05 mins prior to product administration, 0 min and 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(05 mins prior to product administration and 15, 30, 60, 90 and 120 minutes post product administration on each product administration day.)
研究者
Dr Simran Sethi
Cliantha Research