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

July 16, 2020 updated by: JeyaKumar Henry, Clinical Nutrition Research Centre, Singapore
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™)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 117599
        • Clinical Nutrition Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Biscuit 1 Control
Consumption of control biscuit for breakfast and afternoon snack and impact on postprandial glucose and insulin
Other: Biscuit 1 Control
Consumption of control biscuit of a higher glycaemic index at one session during breakfast and afternoon snack
Experimental: Biscuit 2 Test
Consumption of test biscuit for breakfast and afternoon snack on postprandial glucose and insulin
Other: Biscuit 2 Test
Consumption of test biscuit of a lower glycaemic index at one session during breakfast and afternoon snack

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Postprandial glucose
Time Frame: Up to 24 hours
Glucose measurements taken using the Continuous Glucose Monitoring System
Up to 24 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Postprandial insulin
Time Frame: up to 180 minutes
Plasma blood will be analyzed using COBAS
up to 180 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Clinical Nutrition Research Centre, Singapore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 20, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 22, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 22, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 3, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 4, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 17, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018/01066

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings