Bed and Breakfast (B&B) Study

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: High GI Breakfast; Other: Low GI Breakfast; Other: High GI Dinner; Other: Low GI Dinner

• Registration Number: NCT02927600
• Lead Sponsor: Société des Produits Nestlé (SPN)

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.

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-14
• Study First Submitted QC: 2016-10-06
• Study First Posted: 2016-10-07
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-09
• Last Update Posted: 2017-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High GI rice Breakfast	High GI Breakfast	Intake of High GI breakfast
Low GI Rice Breakfast	Low GI Breakfast	Intake of low GI breakfast
High GI Rice Dinner	High GI Dinner	Intake of High GI dinner
Low GI Rice Dinner	Low GI Dinner	Intake of low GI dinner

Primary Outcome Measures

Name	Time	Method
Glycemia	3 hours	Incremental areas under curve (iAUC) of glycemia in the 3 hours following meal intake

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Clinical Nutrition Research Center; 🇸🇬 Singapore, Singapore