The Impact of Low Glycaemic Index (GI) Biscuits on Postprandial Glycaemia Using the Continuous Glucose Monitoring System (CGMS™) (Biscuit Study (BIS) Study)
Primary Purpose
Diabetes Mellitus, Type 2, Diabetes
Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Biscuit 1 Control
Biscuit 2 Test
Sponsored by

About this trial
This is an interventional other trial for Diabetes Mellitus, Type 2
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Clinical Nutrition Research Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Biscuit 1 Control
Biscuit 2 Test
Arm Description
Consumption of control biscuit for breakfast and afternoon snack and impact on postprandial glucose and insulin
Consumption of test biscuit for breakfast and afternoon snack on postprandial glucose and insulin
Outcomes
Primary Outcome Measures
Postprandial glucose
Glucose measurements taken using the Continuous Glucose Monitoring System
Secondary Outcome Measures
Postprandial insulin
Plasma blood will be analyzed using COBAS
Full Information
NCT ID
NCT04115579
First Posted
October 3, 2019
Last Updated
July 16, 2020
Sponsor
Clinical Nutrition Research Centre, Singapore
1. Study Identification
Unique Protocol Identification Number
NCT04115579
Brief Title
The Impact of Low Glycaemic Index (GI) Biscuits on Postprandial Glycaemia Using the Continuous Glucose Monitoring System (CGMS™) (Biscuit Study (BIS) Study)
Official Title
The Impact of Low Glycaemic Index (GI) Biscuits on Postprandial Glycaemia Using the Continuous Glucose Monitoring System (CGMS™) (Biscuit Study (BIS) Study)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
February 20, 2019 (Actual)
Primary Completion Date
June 22, 2020 (Actual)
Study Completion Date
June 22, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clinical Nutrition Research Centre, Singapore
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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™)
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 session separated by at least three days (to avoid crossover effects). Test foods: The foods were Control and Test [Low glycemic index (GI)] biscuits. The foods will vary in macronutrient, micronutrients and fibre contents. Screening session: Potential participants attend a first session for consenting and screening procedures. Subjects will be at the centre for the study between 8:00-9:00am, with screening session lasting approximately 1 hour. Subjects will have to come following a 10-12 hour overnight fast each day. Fingerprick blood sample (5μl) is required for the screening session (to establish fasting glucose concentration). Screening questionnaire: The screening questionnaire will include contact information, demographic, general health details, and physical activity level. This information will be used to determine whether the participant is eligible for the study, as well as to check for any possible confounders that may influence the study outcomes. Anthropometric measurements: Body weight and body composition will be measured using bioelectrical impedance analysis (Tanita scale). Height will be measured using a stadiometer in order to calculate participants' BMI. Waist circumference will be measured at the minimum circumference between the iliac crest and the rib cage. Hip circumference will be measured at the maximum protuberance of the buttocks. Biceps and triceps skinfold measurements will also be taken. Blood pressure will also be measured. Blood pressure: Blood pressure will be measured using an Omron blood pressure monitor (Model HEM-907) at baseline. Participants will be seated for five minutes before blood pressure is measured. Measurements will be taken in duplicate and the averaged results will be recorded. (approximately 1 teaspoon or 5 ml) will be collected from subject via passive drooling (only once during). Start of test session (Day 0-Day 2) Day 0 If subject is eligible, subjects will be enrolled into the study. Subject will undergo the insertion of the Continuous Glucose Monitoring System (CGMS™) sensor the day before the test day (Day 0) to allow for the monitor to stabilize overnight. Medtronic's iPro2 Professional CGMS, designed to gain more complete insights into the glycaemic profiles of a person. The CGMS sensor will be inserted into the adipose tissue in the abdominal area by trained researchers and nurses. Subjects will have to wait in the laboratory for 1 hour after insertion for the sensor to be stabilized. After 1 hour the inserted CGMS sensor will be calibrated against a manual finger-prick blood glucose sample (5 μL, a small drop). Manual calibration using finger-prick blood samples will need to be carried out before every meal and before bed in the night (5 μL each for before dinner and before sleeping). The calibrations before dinner and bed will have to be carried out the subjects at home. Therefore, the subjects will be provided with a finger-prick blood glucose test kit to take home and instructed on how to correctly use it and measure blood glucose values. Calibration finger pricks will be made using disposable individual lancets. This may cause minimal discomfort. The volume of blood taken each time will be 5 μL (a small drop). For Day 0, subjects will be provided a standard dinner meal to be consumed at home at 7pm. Afterwhich, they will be asked to not eat and drink anything except water after 10:30 pm. They will also be instructed to arrive at the CNRC the following morning in an overnight fasted state. On the evenings before the test sessions, subject will be reminded to have no strenuous physical activities and no consumption of alcoholic beverages. Day 1 On the test Day 1, participants will be asked to attend the testing sessions after an overnight fast of ten to twelve hours, and arrive between 8:00-9:00am, with each session lasting approximately 4 hours. One fasting blood sample will be collected by fingerprick for calibration of the CGMS glucose meter (5 μL, a small drop). Then, an indwelling catheter will be inserted into a vein in the forearm. Subsequently, a blood sample will be taken from a cannula to measure baseline values. Immediately after that, participants will be served a test breakfast, where they will be asked to consume within 15 minutes. Following the test breakfast meal, further blood samples will be taken (from the cannula) for the next 15, 30, 45, 60, 90, 120, 150, 180 minutes. The blood samples collected at each timepoint will be measured for insulin and metabolic biomarkers related to the intake of the test meal ingredients. The amount of blood that will be collected at every time point will be about 1.2 teaspoon of blood (approximately 6 ml), the accumulative amount per test session will not be more than 11 teaspoons of blood (approximately 55 ml), and the accumulative amount for the entire study duration will not be more than 22 teaspoons of blood (approximately 110 ml), by cannula. For the fingerprick calibration, 5 μL is taken after insertion of sensor, before each meal and before sleeping. So a total of 9 fingerpricks will be taken for one test session. Therefore, a total of 18 fingerpricks for the entire two sessions. (approximately 90 μL equivalent to approximately 1/5 of a teaspoon). A standard lunch will then be served and afterwhich the cannula is removed. Subjects will take a fingerprick blood glucose (5 μL, a small drop) for calibration of the CGMS before their standard lunch meal. Subjects are to consume the entire lunch meal in 15 minutes. After lunch, participants will be provided with their snack and dinner meal to be consumed at home and they will leave the research facility. Before snack, dinner and before sleeping, participants are to take their own fingerprick blood glucose for calibration of the CGMS.Day 2 Participants will return the following day, Day 2, between 8:00-9:00am. Participants will have the CGMS sensor removed. A final fingerprick (5 μL, a small drop) for calibration purposes will be done 15 minutes before removal of the sensor. This marks the end of one session and participant will return for the next session after 3 days of washout period. Participants attend a total of about 15 hours for two sessions (including one screening visit lasting around 1 hour). Participants will spend approximately 1 hour for screening session, 1 hour for Day 0, 4 hours for Day 1 and about half hour on Day 2. This will repeat for the next session. All test and standard meals in the research facility will be served with 250ml of water. All the study diets will be prepared in the CNRC food preparation kitchen and will use locally sourced ingredients and food purchased from local supermarkets and food distributors.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Diabetes
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Biscuit 1 Control
Arm Type
Experimental
Arm Description
Consumption of control biscuit for breakfast and afternoon snack and impact on postprandial glucose and insulin
Arm Title
Biscuit 2 Test
Arm Type
Experimental
Arm Description
Consumption of test biscuit for breakfast and afternoon snack on postprandial glucose and insulin
Intervention Type
Other
Intervention Name(s)
Biscuit 1 Control
Intervention Description
Consumption of control biscuit of a higher glycaemic index at one session during breakfast and afternoon snack
Intervention Type
Other
Intervention Name(s)
Biscuit 2 Test
Intervention Description
Consumption of test biscuit of a lower glycaemic index at one session during breakfast and afternoon snack
Primary Outcome Measure Information:
Title
Postprandial glucose
Description
Glucose measurements taken using the Continuous Glucose Monitoring System
Time Frame
Up to 24 hours
Secondary Outcome Measure Information:
Title
Postprandial insulin
Description
Plasma blood will be analyzed using COBAS
Time Frame
up to 180 minutes
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Healthy male volunteers
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Facility Information:
Facility Name
Clinical Nutrition Research Centre
City
Singapore
ZIP/Postal Code
117599
Country
Singapore
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Impact of Low Glycaemic Index (GI) Biscuits on Postprandial Glycaemia Using the Continuous Glucose Monitoring System (CGMS™) (Biscuit Study (BIS) Study)
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