Clinical trial NCT02927600: Bed and Breakfast (B&B) Study
Official title: Impact of Low Glycemic Responses Breakfast or Dinner on Postprandial Glycemia of the Subsequent Meals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Glycemic response
Glycemic index
Meal intervention
Chinese population
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
Collaborators: name: Singapore Institute of Food and Biotechnology Innovation
First posted: 2016-10-07
Enrollment: 48
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)
* 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.

Primary outcomes:
measure: Glycemia
timeFrame: 3 hours
Secondary outcomes:
measure: Glycemia
timeFrame: 24h
measure: Plasma glucagon
timeFrame: 3 hours
measure: Plasma insulin
timeFrame: 3 hours post meal intake
measure: Plasma triglycerides
timeFrame: 3 hours post meal intake
measure: Plasma glycerol
timeFrame: 3 hours post meal intake
measure: Plasma free fatty acids
timeFrame: 3 hours
measure: Satiety
timeFrame: Every 30 minutes over the 3 hours post meal intake
measure: Hunger
timeFrame: Every 30 minutes over the 3 hours post meal intake
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Clinical Nutrition Research Center
Study officials:
affiliation: Centre for Translational Medicine
name: Christiani Jeyakumar Henry, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.