Status:
COMPLETED
The Impact of Low Glycaemic Index (GI) Biscuits on Postprandial Glycaemia Using the Continuous Glucose Monitoring System (CGMS™) (Biscuit Study (BIS) Study)
Lead Sponsor:
Singapore Institute of Food and Biotechnology Innovation
Conditions:
Diabetes Mellitus, Type 2
Diabetes
Eligibility:
MALE
21-40 years
Phase:
NA
Brief Summary
To investigate whether low glycaemic index (GI) biscuits have the greatest impact on the post-meal glucose response and on the overall 24 hour blood glucose control, using the continuous glucose monit...
Detailed Description
The study was a randomized, non-blinded, crossover design. Randomization conducted using www.randomizer.org. Each participant came for two test sessions (each of 3 days- Days 0, 1 and 2) with each ses...
Eligibility Criteria
Inclusion
- Males
- Healthy Asian Chinese
- Aged between 21 - 40 years
- Body mass index between 18.5 to 25.0 kg/m2
- Normal blood pressure \<140/90 mmHg
- Fasting blood glucose \<6.0 mmol/L
Exclusion
- Smoking
- Allergic/intolerant to any of the test foods to be administered, or any of the following common food and ingredients: eggs, fish, milk, peanuts, and tree nuts, shellfish, soya, wheat, gluten, cereal, fruits, dairy products, meat, vegetable, sugar and sweetener, natural food colourings or flavourings, etc.
- Anyone with intentional food restrictions
- People with known glucose-6-phosphate dehydrogenase deficiency (G6PD deficiency)
- Having metabolic or cardiovascular diseases (such as diabetes, hypertension, heart condition, etc), Having any other diseases involving the small intestine or the colon (e.g., irritable bowel syndrome, inflammatory bowel disease, gastric reflux) or having any liver or kidney disorders or any family history of kidney stones
- Having medical conditions and/or taking medications known to affect glycemia (glucocorticoids, thyroid hormones, thiazide diuretics)
- Taking any prescribed medication or dietary supplements which may interfere with the study measurements
- Excessive alcohol consumption: consuming ≥ 6 alcoholic drinks per week
- Individuals who have donated blood or taken part in other studies within 4 weeks of study participation.
- Have poor veins impeding venous access
- Have history of severe vasovagal syncope (blackouts or near faints) following blood draws
- Have known Chronic infection or known to suffer from or have previously suffered from or is a carrier of Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV)
- Have active Tuberculosis (TB) or currently receiving treatment for TB
- Individuals who partake in sports at the competitive and/or endurance levels.
- A team member of the study or is an immediate family member (Immediate family defined as a spouse, parent, child, or sibling, whether biological or legally adopted
Key Trial Info
Start Date :
February 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 22 2020
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04115579
Start Date
February 20 2019
End Date
June 22 2020
Last Update
July 17 2020
Active Locations (1)
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1
Clinical Nutrition Research Centre
Singapore, Singapore, 117599