HealthyNCT02927600
Bed and Breakfast (B&B) Study
A study testing Low GI Breakfast, High GI Breakfast and Low GI Dinner in people with Healthy, run by Société des Produits Nestlé (SPN) at 1 site in Singapore.
Trial summary
The primary objective is to determine which among high vs low Glycemic Index (GI) / Glycemic Responses (GR) interventions at breakfast or at dinner is the most effective for lowering glycemic response of the subsequent standard meal. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Low GI Breakfast, High GI Breakfast and Low GI Dinner
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSingapore
- Study dates
- Sep 2016to Oct 2017
- 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 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 50 to ≤ 70 years old years
- Chinese male and female healthy subjects having both grandparents Chinese
- Body mass index: ≥ 18.5 to ≤ 24.9kg/m2
- Waist circumference ≤90 cm for males and ≤ 85 cm for females
- Systolic blood pressure <150 mmHg; Diastolic blood pressure <90 mmHg
- Willing and able to sign written informed consent prior to trial entry
Who cannot join
- Known Diabetes type 2, under medication
- Fasting Glycemia > 7 mmol/L
- Any clinically relevant gastrointestinal (ulcer, malabsorption), renal (insufficiency), cardiovascular (stroke, arterial hypertension, heart disease), metabolic disease (dyslipidemia), psychiatric disorder (depression) that would affect the study in the opinion of the CNRC clinician, according to a detailed medical history and a blood sampling at screening, only if deemed necessary by CNRC clinician.
- Anemia (anamnesis)
- Subjects who had a history of major gastrointestinal surgery
- Subjects who had more than 5% weight loss from baseline weight during the past three months (more than 5% of initial weight)
Show all 13Show fewer
- Present drug abuse or use of medications that could interfere with the treatment or energetic metabolism including corticosteroids, growth hormone, hormonal replacement therapy, anti-hypertensives like ACE inhibitor, thiazides and angiotensin receptors blockers. These conditions will be screened based on subject reporting. Participants will be asked to bring in their current medications at the time of screening, and these will be checked by the study-staff.
- Subject allergic /intolerant to any of the test foods 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.
- Subject on special diets especially vegetarian, high protein or weight loss program.
- Current smokers (i.e. people having smoked in the month preceding the enrolment)
- Subjects having a high alcohol consumption (more than 2 drinks/day)
- Subjects who are not willing and not able to comply with scheduled visits and the requirements of the study procedures in the opinion of the investigators.
- Currently participating or having participated in another clinical trial within 4 weeks prior to trial start.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Low Glycemic Responses Breakfast or Dinner on Postprandial Glycemia of the Subsequent Meals
The primary objective is to determine which among high vs low Glycemic Index (GI) / Glycemic Responses (GR) interventions at breakfast or at dinner is the most effective for lowering glycemic response of the subsequent standard meal.
Read the detailed description
Consumption of low Glycemic Index (GI) foods has been shown to not only attenuate blood glucose response during the postprandial period immediately following a meal but to have also positive metabolic effects at the subsequent meal, known as the "second-meal effect" by reducing glucose excursion beyond actual meal. The relative importance of the timing of the glycemic load variation (e.g., breakfast or dinner) on the overall, 24h, glycemic control has not been investigated in detail.
We hypothesize that eating low GI foods in a single meal either for breakfast or for dinner would have different consequential effects on glycemic control over the following meal and thereafter during 24 hours. In order to establish the relative importance of breakfast or dinner in predicting glycemic control/response of the following meal and for a 24-hour period this study will use comprehensive methods including Continuous Glucose Monitoring Systems (CGMS) as well as measuring postprandial blood glucose and insulin.
- Conditions
- Healthy
- Being tested
- Low GI Breakfast, High GI Breakfast, Low GI Dinner, High GI Dinner
- Keywords
- Glycemic response, Glycemic index, Meal intervention, Chinese population
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low GI BreakfastOther
Intake of low GI breakfast
High GI BreakfastOther
Intake of high GI breakfast
Low GI DinnerOther
Intake of Low GI dinner
High GI DinnerOther
Intake of high GI dinner
| Study group | Role | What they receive |
|---|---|---|
| Low GI Rice Breakfast | Experimental | Intake of low GI breakfast Receives: Other: Low GI Breakfast |
| High GI rice Breakfast | Experimental | Intake of High GI breakfast Receives: Other: High GI Breakfast |
| Low GI Rice Dinner | Experimental | Intake of low GI dinner Receives: Other: Low GI Dinner |
| High GI Rice Dinner | Experimental | Intake of High GI dinner Receives: Other: High GI Dinner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemia
Incremental areas under curve (iAUC) of glycemia in the 3 hours following meal intake
Measured: 3 hours
Secondary outcomes (8)
Glycemia
Incremental areas under curve (iAUC) of glycemia over 24 hours
Measured: 24h
Plasma glucagon
Measure of plasma glucagon over a 3-h period following meal intake
Measured: 3 hours
Plasma insulin
Measure of plasma insulin over a 3-h period following meal intake
Measured: 3 hours post meal intake
Plasma triglycerides
Measure of plasma triglycerides over a 3-h period following meal intake
Measured: 3 hours post meal intake
Plasma glycerol
Measure of plasma glycerol over a 3-h period following meal intake
Measured: 3 hours post meal intake
Plasma free fatty acids
Measure of plasma free fatty acids over a 3-h period following meal intake
Measured: 3 hours
Satiety
Satiety will be assessed by Visual Analog Scales
Measured: Every 30 minutes over the 3 hours post meal intake
Hunger
Hunger will be assessed by Visual Analog Scales
Measured: Every 30 minutes over the 3 hours post meal intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2016 (estimated)
- Study startSep 2016
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Singapore Institute of Food and Biotechnology Innovation
- Responsible party
- Sponsor
- Investigators
- Christiani Jeyakumar Henry, Prof, Principal investigator, Centre for Translational Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02927600
- Sponsor's protocol ID
- 15.18.NRC
- Status last verified
- Nov 2017
- First submitted
- 14 Sep 2016
- Last updated
- 13 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Haldar S, Egli L, De Castro CA, Tay SL, Koh MXN, Darimont C, Mace K, Henry CJ. High or low glycemic index (GI) meals at dinner results in greater postprandial glycemia compared with breakfast: a randomized controlled trial. BMJ Open Diabetes Res Care. 2020 Apr;8(1):e001099. doi: 10.1136/bmjdrc-2019-001099.
PubMed 32327444
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Low Glycemic Responses Breakfast or Dinner on Postprandial Glycemia of the Subsequent Meals
- ClinicalTrials.gov ID
- NCT02927600
- Acronym / sponsor ID
- 15.18.NRC
- Conditions
- Healthy
- Keywords
- Glycemic response, Glycemic index, Meal intervention, Chinese population
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Collaborators
- Singapore Institute of Food and Biotechnology Innovation
- Study start
- Sep 2016
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 7 Oct 2016 (estimated)
- 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 primary objective is to determine which among high vs low Glycemic Index (GI) / Glycemic Responses (GR) interventions at breakfast or at dinner is the most effective for lowering glycemic response of the subsequent standard meal.
Detailed description
Consumption of low Glycemic Index (GI) foods has been shown to not only attenuate blood glucose response during the postprandial period immediately following a meal but to have also positive metabolic effects at the subsequent meal, known as the "second-meal effect" by reducing glucose excursion beyond actual meal. The relative importance of the timing of the glycemic load variation (e.g., breakfast or dinner) on the overall, 24h, glycemic control has not been investigated in detail.
We hypothesize that eating low GI foods in a single meal either for breakfast or for dinner would have different consequential effects on glycemic control over the following meal and thereafter during 24 hours. In order to establish the relative importance of breakfast or dinner in predicting glycemic control/response of the following meal and for a 24-hour period this study will use comprehensive methods including Continuous Glucose Monitoring Systems (CGMS) as well as measuring postprandial blood glucose and insulin.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low GI Rice Breakfast | Experimental | Other: Low GI BreakfastIntake of low GI breakfast |
| High GI rice Breakfast | Experimental | Other: High GI BreakfastIntake of High GI breakfast |
| Low GI Rice Dinner | Experimental | Other: Low GI DinnerIntake of low GI dinner |
| High GI Rice Dinner | Experimental | Other: High GI DinnerIntake of High GI dinner |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 50 to ≤ 70 years old years
- Chinese male and female healthy subjects having both grandparents Chinese
- Body mass index: ≥ 18.5 to ≤ 24.9kg/m2
- Waist circumference ≤90 cm for males and ≤ 85 cm for females
- Systolic blood pressure <150 mmHg; Diastolic blood pressure <90 mmHg
Key exclusion criteria (13 listed)
- Known Diabetes type 2, under medication
- Fasting Glycemia > 7 mmol/L
- Any clinically relevant gastrointestinal (ulcer, malabsorption), renal (insufficiency), cardiovascular (stroke, arterial hypertension, heart disease), metabolic disease (dyslipidemia), psychiatric disorder (depression) that would affect the study in the opinion of the CNRC clinician, according to a detailed medical history and a blood sampling at screening, only if deemed necessary by CNRC clinician.
- Anemia (anamnesis)
- Subjects who had a history of major gastrointestinal surgery
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 |
|---|---|---|
| Low GI BreakfastIntake of low GI breakfast | Other | Low GI Rice Breakfast |
| High GI BreakfastIntake of high GI breakfast | Other | High GI rice Breakfast |
| Low GI DinnerIntake of Low GI dinner | Other | Low GI Rice Dinner |
| High GI DinnerIntake of high GI dinner | Other | High GI Rice Dinner |
Primary outcome
Glycemia
Time frame: 3 hours
Incremental areas under curve (iAUC) of glycemia in the 3 hours following meal intake
8 secondary outcomes
Glycemia
Time frame: 24h
Plasma glucagon
Time frame: 3 hours
Plasma insulin
Time frame: 3 hours post meal intake
Plasma triglycerides
Time frame: 3 hours post meal intake
Plasma glycerol
Time frame: 3 hours post meal intake
Plasma free fatty acids
Time frame: 3 hours
Satiety
Time frame: Every 30 minutes over the 3 hours post meal intake
Hunger
Time frame: Every 30 minutes over the 3 hours post meal intake
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 Nov 2017.
- Derived from this study: PubMed 32327444Haldar S, Egli L, De Castro CA, Tay SL, Koh MXN, Darimont C, Mace K, Henry CJ. High or low glycemic index (GI) meals at dinner results in greater postprandial glycemia compared with breakfast: a randomized controlled trial. BMJ Open Diabetes Res Care. 2020 Apr;8(1):e001099. doi: 10.1136/bmjdrc-2019-001099.
- 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.
Christiani Jeyakumar Henry, Prof principal investigator
Centre for Translational Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low GI Breakfast, High GI Breakfast and Low GI Dinner in people with Healthy, run by Société des Produits Nestlé (SPN) 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 Nov 2017. 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?
Glycemia (time frame: 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02927600, which also lists 1 linked publication.
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 Nov 2017.