Bed and Breakfast (B&B) Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Impact of Low Glycemic Responses Breakfast or Dinner on Postprandial Glycemia of the Subsequent Meals

Conditions
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Healthy

Intervention / Treatment
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* Other: Low GI Breakfast
* Other: High GI Breakfast
* Other: Low GI Dinner
* Other: High GI Dinner


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low GI Rice Breakfast<br>Intake of low GI breakfast | Other: Low GI Breakfast<br>* Intake of low GI breakfast<br>|
| Experimental: High GI rice Breakfast<br>Intake of High GI breakfast | Other: High GI Breakfast<br>* Intake of high GI breakfast<br>|
| Experimental: Low GI Rice Dinner<br>Intake of low GI dinner | Other: Low GI Dinner<br>* Intake of Low GI dinner<br>|
| Experimental: High GI Rice Dinner<br>Intake of High GI dinner | Other: High GI Dinner<br>* Intake of high GI dinner<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glycemic response, Glycemic index, Meal intervention, Chinese population