Glycemic ResponseBEGINNCT03257059
Breakfast Consumption and Its Effects on Glycemic, Insulinemic and Non-Esterified Fatty Acids Responses
A study testing Breakfast and No Breakfast in people with Glycemic Response, run by JeyaKumar Henry at 1 site in Singapore.
Trial summary
The aim of this study is to determine whether eating breakfast or having no breakfast has subsequent beneficial health effects, specifically in relation to glycemic response throughout the day and postprandial insulin and non-esterified fatty acids (NEFA) responses 6 hours after breakfast/lunch. Read more about this study
- Who is it for?
- Ages 40 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Glycemic Response
- What is being tested?
- Breakfast and No Breakfast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteSingapore
- Study dates
- 25 Jul 2017to 28 Mar 2019
- 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 40 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Chinese males
- BMI above 23.0 kg/m2
- Age between 40-65 years
- Normal blood pressure (<140/90 mmHg)
- Fasting blood glucose of ≥5.6 mmol/L
- Self-reported regular breakfast consumers
Who cannot join
- Have known glucose-6-phosphate dehydrogenase (G6PD) deficiency
- major chronic disease such as heart disease, cancer or diabetes mellitus
- taking insulin or drugs known to affect glucose metabolism
- Intentionally restrict food intake
- major medical or surgical event requiring hospitalization within the preceding 3 months
- Have taken antibiotics for 3 months before the study period
Show all 13Show fewer
- Smoking
- Overnight shift workers
- Any known food allergy (eg. anaphylaxis to peanuts)
- Having active Tuberculosis (TB) or currently receiving treatment for TB
- Any 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)
- Being a member of the research team or their immediate family members. Immediate family member is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
- Enrolled in a concurrent research study judged not to be scientifically or medically compatible with the study of the CNRC.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to determine whether eating breakfast or having no breakfast has subsequent beneficial health effects, specifically in relation to glycemic response throughout the day and postprandial insulin and non-esterified fatty acids (NEFA) responses 6 hours after breakfast/lunch.
Read the detailed description
This will be a randomised, crossover study with two treatments in total. 1.) Subjects given with breakfast, 2.) Subjects not given breakfast. Each of the two test visits will last for approximately 9 hour (spanning over 3 days), during which the following will take place: On Day 1, subjects will come to have the continuous glucose monitoring (CGMS) system inserted. CGMS will be used to measure 24 hour blood glucose concentrations. On Day 2, an indwelling catheter will be inserted into the ante cubital fossa or forearm vein of one arm and will be kept patent. One fasting blood sample (baseline; 4 milliliters of venous blood) will be collected. Participants with breakfast treatment will then consume the test meal within 15 minutes. Subsequently, blood samples will be taken at 15, 30, 45, 60, 90, 120, 150 and 180 minutes.At time 180 minutes, participants will be given a standardized lunch to be consumed within 30 minutes. Blood samples will be taken after lunch at 210, 240, 270, 300, 330 and 360 minutes. On Day 3, subjects will need to come for removal of the CGMS sensor. Subjects will come to the CNRC again for the 2nd test visit, with at least 3 days wash-out in-between visits.
- Conditions
- Glycemic Response
- Being tested
- Breakfast, No Breakfast
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BreakfastOther
Glutinous rice (75 grams of available carbohydrate)
No BreakfastOther
No food to be served in the morning
| Study group | Role | What they receive |
|---|---|---|
| Breakfast | Experimental | Subject given standardized breakfast (glutinous rice) to test blood glucose response Receives: Other: Breakfast |
| No breakfast | Experimental | Subject not given breakfast to test blood glucose response Receives: Other: No Breakfast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic response
Using continuous glucose monitoring system
Measured: 1.5 days
Insulin response
Postprandial after treatment
Measured: 6 hours
Non-esterified fatty acids (NEFA) response
Postprandial after treatment
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study start25 Jul 2017
- Primary completion28 Mar 2019
- Study completion28 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glycemic ResponseStudies 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
- Model description
- Randomised, crossover study with two treatments
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- JeyaKumar Henry
- Sponsor type
- Other government
- Collaborators
- General Mills
- Responsible party
- Sponsor-investigator, JeyaKumar Henry, Singapore Institute of Food and Biotechnology Innovation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03257059
- Sponsor's protocol ID
- 2017/00537
- Other IDs
- 2017
- Acronym
- BEGIN
- Status last verified
- May 2019
- First submitted
- 9 Aug 2017
- Last updated
- 13 May 2019
- 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 13 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breakfast Consumption and Its Effects on Glycemic, Insulinemic and Non-Esterified Fatty Acids Responses
- ClinicalTrials.gov ID
- NCT03257059
- Acronym / sponsor ID
- BEGIN / 2017/00537
- Conditions
- Glycemic Response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- JeyaKumar HenryOther government
- Collaborators
- General Mills
- Study start
- 25 Jul 2017 (actual)
- Primary completion
- 28 Mar 2019 (actual)
- Study completion
- 28 Mar 2019 (actual)
- First posted
- 22 Aug 2017 (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.
The aim of this study is to determine whether eating breakfast or having no breakfast has subsequent beneficial health effects, specifically in relation to glycemic response throughout the day and postprandial insulin and non-esterified fatty acids (NEFA) responses 6 hours after breakfast/lunch.
Detailed description
This will be a randomised, crossover study with two treatments in total. 1.) Subjects given with breakfast, 2.) Subjects not given breakfast. Each of the two test visits will last for approximately 9 hour (spanning over 3 days), during which the following will take place: On Day 1, subjects will come to have the continuous glucose monitoring (CGMS) system inserted. CGMS will be used to measure 24 hour blood glucose concentrations. On Day 2, an indwelling catheter will be inserted into the ante cubital fossa or forearm vein of one arm and will be kept patent. One fasting blood sample (baseline; 4 milliliters of venous blood) will be collected. Participants with breakfast treatment will then consume the test meal within 15 minutes. Subsequently, blood samples will be taken at 15, 30, 45, 60, 90, 120, 150 and 180 minutes.At time 180 minutes, participants will be given a standardized lunch to be consumed within 30 minutes. Blood samples will be taken after lunch at 210, 240, 270, 300, 330 and 360 minutes. On Day 3, subjects will need to come for removal of the CGMS sensor. Subjects will come to the CNRC again for the 2nd test visit, with at least 3 days wash-out in-between visits.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised, crossover study with two treatments
| Arm | Type | Receives |
|---|---|---|
| Breakfast | Experimental | Other: BreakfastSubject given standardized breakfast (glutinous rice) to test blood glucose response |
| No breakfast | Experimental | Other: No BreakfastSubject not given breakfast to test blood glucose response |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Chinese males
- BMI above 23.0 kg/m2
- Age between 40-65 years
- Normal blood pressure (<140/90 mmHg)
- Fasting blood glucose of ≥5.6 mmol/L
Key exclusion criteria (13 listed)
- Have known glucose-6-phosphate dehydrogenase (G6PD) deficiency
- major chronic disease such as heart disease, cancer or diabetes mellitus
- taking insulin or drugs known to affect glucose metabolism
- Intentionally restrict food intake
- major medical or surgical event requiring hospitalization within the preceding 3 months
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 |
|---|---|---|
| BreakfastGlutinous rice (75 grams of available carbohydrate) | Other | Breakfast |
| No BreakfastNo food to be served in the morning | Other | No breakfast |
Primary outcome
Glycemic response
Time frame: 1.5 days
Using continuous glucose monitoring system
Insulin response
Time frame: 6 hours
Postprandial after treatment
Non-esterified fatty acids (NEFA) response
Time frame: 6 hours
Postprandial after treatment
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 13 May 2019.
- 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 Breakfast and No Breakfast in people with Glycemic Response, run by JeyaKumar Henry 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 6 inclusion and 13 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 13 May 2019. 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?
Glycemic response (time frame: 1.5 days). The study lists 3 primary outcomes in all. 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 13 May 2019.