A Randomized, Cross Over, Single Centric Clinical Study to Determine the Glycemic Index of Two Test Biscuits 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 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 biscuits 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 biscuits 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 04)
2nd Product Administration (Day 05)
· Visit 03: Admission Day (Day 08)
3rd Product Administration (Day 09)
· Visit 04: Enrolment Visit and Admission Day (Day 12)
4th Product Administration (Day 13)
· Visit 05: Admission Day (Day 16)
5th Product Administration (Day 17)
There will be a washout period of 03 days between dosesto prevent the carry-over effect of the previous visit day’s reference or test food intake.
Incremental area under the blood glucose response curve (IAUC) [Predose (5 mins ± 1 min), 0 min (+ 1 min), 15 mins (± 2 mins), 30 mins (± 2 mins), 45 mins (± 2 mins), 60 mins (± 2 mins), 90 mins (± 2 mins) and 120 mins (± 2 mins)], for reference and the test products will be determined for the assessment of glycemic index.
GI score will be calculated by the formula:
GI = Blood Glucose IAUC value for test products/Average IAUC value of standard glucose * 100
Satiety will be assessed using an equilateral 7-point rating scale at Predose (5 mins ± 1 min), 0 minute (+ 1 mins) (i.e., the time when the first bite in the mouth is taken)and after administration of product, at 15, 30, 60, 90, 120, 180 and 240 minutes (+5 mins – window period is for all time-points after product administration).
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 below100 mg/dL.
- •Participants having HbA1c level below 5.7 % 4) Participants with Body Mass Index of 18.5 to 22.9 kg/m2 (both inclusive).
- •Female participants of childbearing potential must have a negative urine pregnancy test performed during screening.
- •Participants who agree to refrain from vigorous physical exercise during the study period.
- •Participants with no medications known to affect glucose tolerance (excluding oral contraceptives) — stable doses of oral contraceptives, acetylsalicylic acid, thyroxin, vitamins and mineral supplements or drugs to treat hypertension or osteoporosis.
- •Participants with no history of cardiovascular disease.
- •Participants who have not donated blood within 30 days prior to screening.
排除标准
- •Participants with any known food allergy or intolerance to any food or beverages.
- •Participants with allergies to wheat, gluten, dairy, or other common biscuit ingredients.
- •Participants with presence of any chronic disease or illness in the past three months or any clinically significant on-going chronic medical illness e.g., Congestive cardiac failure, Hepatitis, Hypotensive episodes, etc.
- •Participants with recent history of dehydration from diarrhea, 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, 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 8) Participants having history of Hepatitis B or C virus.
- •Participants with a known history of diabetes mellitus or the use of anti-hyperglycaemic drugs or insulin to treat diabetes and related conditions.
- •Participants with the presence of disease or drug(s) which influence digestion and absorption of nutrients.
- •Participants with the use of steroids, protease inhibitors or antipsychotics (all of which have major effects on glucose metabolism and body fat distribution).
- •Participants with a history of significant gastrointestinal disorders (e.g., inflammatory bowel disease, gastroparesis) that could affect absorption or digestion.) 13) Participants with any known kidney or liver disease.
结局指标
主要结局
To determine the glycemic index of test products, in healthy participants.
时间窗: 5 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.(5 mins prior to product administration, 0 min and 15, 30, 60, 90, 120, 180 and 240 minutes post product administration on each product administration day.)
研究者
Dr Simran Sethi
Cliantha Research