Bed and Breakfast (B&B) Study

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Low GI Breakfast; Other: High GI Breakfast; Other: Low GI Dinner; Other: High GI Dinner

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 Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 117599
    • Clinical Nutrition Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Low GI Rice Breakfast; Intake of low GI breakfast	Other: Low GI Breakfast; Intake of low GI breakfast
EXPERIMENTAL: High GI rice Breakfast; Intake of High GI breakfast	Other: High GI Breakfast; Intake of high GI breakfast
EXPERIMENTAL: Low GI Rice Dinner; Intake of low GI dinner	Other: Low GI Dinner; Intake of Low GI dinner
EXPERIMENTAL: High GI Rice Dinner; Intake of High GI dinner	Other: High GI Dinner; Intake of high GI dinner

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemia	Incremental areas under curve (iAUC) of glycemia in the 3 hours following meal intake	3 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemia	Incremental areas under curve (iAUC) of glycemia over 24 hours	24h
Plasma glucagon	Measure of plasma glucagon over a 3-h period following meal intake	3 hours
Plasma insulin	Measure of plasma insulin over a 3-h period following meal intake	3 hours post meal intake
Plasma triglycerides	Measure of plasma triglycerides over a 3-h period following meal intake	3 hours post meal intake
Plasma glycerol	Measure of plasma glycerol over a 3-h period following meal intake	3 hours post meal intake
Plasma free fatty acids	Measure of plasma free fatty acids over a 3-h period following meal intake	3 hours
Satiety	Satiety will be assessed by Visual Analog Scales	Every 30 minutes over the 3 hours post meal intake
Hunger	Hunger will be assessed by Visual Analog Scales	Every 30 minutes over the 3 hours post meal intake

Collaborators and Investigators

• Sponsor: Nestlé
• Collaborators: Clinical Nutrition Research Centre, Singapore
• Investigators: Principal Investigator: Christiani Jeyakumar Henry, Prof, Centre for Translational Medicine

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (ACTUAL): October 1, 2017
• Study Completion (ACTUAL): October 1, 2017

Study Registration Dates

• First Submitted: September 14, 2016
• First Submitted That Met QC Criteria: October 6, 2016
• First Posted (ESTIMATE): October 7, 2016

Study Record Updates

• Last Update Posted (ACTUAL): November 13, 2017
• Last Update Submitted That Met QC Criteria: November 9, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Glycemic index; Glycemic response; Chinese population; Meal intervention
• Other Study ID Numbers: 15.18.NRC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO