The Impact of Low Glycaemic Index (GI) Biscuits on Postprandial Glycaemia Using the Continuous Glucose Monitoring System (CGMS™) (Biscuit Study (BIS) Study)

NCT04115579 | Completed

• 1 other identifier: 2018/01066
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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 monitoring system (CGMS™)

Conditions

Diabetes Mellitus, Type 2; Diabetes

Outcome Measures

Primary Outcomes (1)

• Postprandial glucose

  Glucose measurements taken using the Continuous Glucose Monitoring System

  Up to 24 hours

Secondary Outcomes (1)

• Postprandial insulin

  up to 180 minutes

Study Arms (2)

Biscuit 1 Control

EXPERIMENTAL

Consumption of control biscuit for breakfast and afternoon snack and impact on postprandial glucose and insulin

Other: Biscuit 1 Control

Biscuit 2 Test

EXPERIMENTAL

Consumption of test biscuit for breakfast and afternoon snack on postprandial glucose and insulin

Other: Biscuit 2 Test

Interventions

Biscuit 1 Control OTHER

Consumption of control biscuit of a higher glycaemic index at one session during breakfast and afternoon snack

Biscuit 1 Control

Biscuit 2 Test OTHER

Consumption of test biscuit of a lower glycaemic index at one session during breakfast and afternoon snack

Biscuit 2 Test

Eligibility Criteria

• Age: 21 Years - 40 Years
• Gender Eligibility Details: Healthy male volunteers
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Singapore Institute of Food and Biotechnology Innovation: lead

Study Sites (1)

Clinical Nutrition Research Centre

Singapore, 117599, Singapore

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 3, 2019
• First Posted: October 4, 2019
• Study Start: February 20, 2019
• Primary Completion: June 22, 2020
• Study Completion: June 22, 2020
• Last Updated: July 17, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)