DiabetesNCT03703544
The Glycaemic Response of Local Foods Using the Continuous Glucose Monitoring System
A study testing High glycemic index and Low glycemic index in people with Diabetes, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.
Trial summary
This study is carried out to determine the effect of high and low GI of local foods using Continuous Glucose Monitoring System (CGMS™) on 24 hour blood glucose profiles. Read more about this study
- Who is it for?
- Ages 21 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- High glycemic index and Low glycemic index
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSingapore
- Study dates
- 15 Dec 2017to 22 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Chinese, male
- Age between 21-50 years
- Body mass index between 18 to 25 kg/m2
- Normal blood pressure (<140/90 Hgmm)
- Fasting blood glucose < 6 mmol/L
Who cannot join
- Current Smoker
- Have any metabolic diseases (such as diabetes, hypertension etc)
- Have known glucose-6-phosphate dehydrogenase deficiency (G6PD deficiency)
- have medical conditions and/or taking medications known to affect glycaemia (glucocorticoids, thyroid hormones, thiazide diuretics)
- Have an ongoing infection or currently undergoing treatment at the time of screening
- 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
- Have intolerances or allergies to any foods
- Partake in sports at the competitive and/or endurance levels
Trial locations and contacts
1 site in 1 country.
About this study
This study is carried out to determine the effect of high and low GI of local foods using Continuous Glucose Monitoring System (CGMS™) on 24 hour blood glucose profiles.
Read the detailed description
Glycemic Index (GI) is a method of classifying foods based on the food's ability to raise the blood glucose level. Low GI foods are recommended as Participants will have a lower impact on blood glucose concentrations. The research sets out to determine the effect of GI on 24 hour blood glucose profiles in healthy Chinese male participants. There will be two test sessions where participants will consume either a high or low GI breakfast, lunch, snack and dinner. Participants will take part in two test sessions (each spanning over 3 days and to monitor the participants' glycemic response using a Continuous Glucose Monitoring System (CGMS) throughout the period.This study specifically attempts to see how having high and low GI locally consumed meals impact on blood glucose.
- Conditions
- Diabetes
- Being tested
- High glycemic index, Low glycemic index
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High glycemic indexOther
Wheat yellow noodle, glutinous rice, tea with sucrose, biscuits, jelly made with sucrose and teriyaki chicken rice.The foods provided have been tested as high glycemic index. Participants' blood glucose will be monitored using the Continuous Glucose Monitor.
Low glycemic indexOther
Beta-glucan yellow noodle, basmati rice, tea with isomaltulose, biscuits, jelly made with isomaltulose and mung bean noodles.The foods provided have been tested as low glycemic index.Participants' blood glucose will be monitored using the Continuous Glucose Monitor.
| Study group | Role | What they receive |
|---|---|---|
| High glycemic index | Experimental | Subjects will consume locally consumed meals which are high glycemic index for breakfast, lunch snack and dinner will be provided.Participants' blood glucose will be monitored using the Continuous Glucose Monitor. Receives: Other: High glycemic index |
| Low glycemic index | Experimental | Subjects will consume locally consumed meals which are low glycemic index for breakfast, lunch snack and dinner will be provided. Participants' blood glucose will be monitored using the Continuous Glucose Monitor. Receives: Other: Low glycemic index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily blood glucose profile
The daily total blood glucose response is measured for each low and high GI treatment as the area under the curve over 24 hours using CGMS for breakfast, lunch, snack and dinner.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2018
- Study start15 Dec 2017
- Primary completion22 May 2020
- Study completion22 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore Institute of Food and Biotechnology Innovation
- Sponsor type
- Other government
- Collaborators
- Health Promotion Board, Singapore
- Responsible party
- Principal investigator, JeyaKumar Henry, Singapore Institute of Food and Biotechnology Innovation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03703544
- Sponsor's protocol ID
- 2017/00994
- Other IDs
- 2017
- Status last verified
- May 2019
- First submitted
- 9 Oct 2018
- Last updated
- 17 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Glycaemic Response of Local Foods Using the Continuous Glucose Monitoring System
- ClinicalTrials.gov ID
- NCT03703544
- Acronym / sponsor ID
- 2017/00994
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Singapore Institute of Food and Biotechnology InnovationOther government
- Collaborators
- Health Promotion Board, Singapore
- Study start
- 15 Dec 2017 (actual)
- Primary completion
- 22 May 2020 (actual)
- Study completion
- 22 May 2020 (actual)
- First posted
- 12 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is carried out to determine the effect of high and low GI of local foods using Continuous Glucose Monitoring System (CGMS™) on 24 hour blood glucose profiles.
Detailed description
Glycemic Index (GI) is a method of classifying foods based on the food's ability to raise the blood glucose level. Low GI foods are recommended as Participants will have a lower impact on blood glucose concentrations. The research sets out to determine the effect of GI on 24 hour blood glucose profiles in healthy Chinese male participants. There will be two test sessions where participants will consume either a high or low GI breakfast, lunch, snack and dinner. Participants will take part in two test sessions (each spanning over 3 days and to monitor the participants' glycemic response using a Continuous Glucose Monitoring System (CGMS) throughout the period.This study specifically attempts to see how having high and low GI locally consumed meals impact on blood glucose.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High glycemic index | Experimental | Other: High glycemic indexSubjects will consume locally consumed meals which are high glycemic index for breakfast, lunch snack and dinner will be provided.Participants' blood glucose will be monitored using the Continuous Glucose Monitor. |
| Low glycemic index | Experimental | Other: Low glycemic indexSubjects will consume locally consumed meals which are low glycemic index for breakfast, lunch snack and dinner will be provided. Participants' blood glucose will be monitored using the Continuous Glucose Monitor. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Chinese, male
- Age between 21-50 years
- Body mass index between 18 to 25 kg/m2
- Normal blood pressure (<140/90 Hgmm)
- Fasting blood glucose < 6 mmol/L
Key exclusion criteria (8 listed)
- Current Smoker
- Have any metabolic diseases (such as diabetes, hypertension etc)
- Have known glucose-6-phosphate dehydrogenase deficiency (G6PD deficiency)
- have medical conditions and/or taking medications known to affect glycaemia (glucocorticoids, thyroid hormones, thiazide diuretics)
- Have an ongoing infection or currently undergoing treatment at the time of screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High glycemic indexWheat yellow noodle, glutinous rice, tea with sucrose, biscuits, jelly made with sucrose and teriyaki chicken rice.The foods provided have been tested as high glycemic index. Participants' blood glucose will be monitored using the Continuous Glucose Monitor. | Other | High glycemic index |
| Low glycemic indexBeta-glucan yellow noodle, basmati rice, tea with isomaltulose, biscuits, jelly made with isomaltulose and mung bean noodles.The foods provided have been tested as low glycemic index.Participants' blood glucose will be monitored using the Continuous Glucose Monitor. | Other | Low glycemic index |
Primary outcome
Daily blood glucose profile
Time frame: 24 hours
The daily total blood glucose response is measured for each low and high GI treatment as the area under the curve over 24 hours using CGMS for breakfast, lunch, snack and dinner.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High glycemic index and Low glycemic index in people with Diabetes, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily blood glucose profile (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2020.