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OpenTrials
Completed

NCT Number: NCT02927600

Bed and Breakfast (B&B) Study

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.

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Key information

Conditions

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Nutrition Research Center

Singapore, 117599

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low GI Breakfast

Other

Intake of low GI breakfast

High GI Breakfast

Other

Intake of high GI breakfast

Low GI Dinner

Other

Intake of Low GI dinner

High GI Dinner

Other

Intake of high GI dinner

Primary outcomes

  1. Glycemia

    Time frame: 3 hours

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

Secondary outcomes

  1. Glycemia

    Time frame: 24h

    Incremental areas under curve (iAUC) of glycemia over 24 hours

  2. Plasma glucagon

    Time frame: 3 hours

    Measure of plasma glucagon over a 3-h period following meal intake

  3. Plasma insulin

    Time frame: 3 hours post meal intake

    Measure of plasma insulin over a 3-h period following meal intake

  4. Plasma triglycerides

    Time frame: 3 hours post meal intake

    Measure of plasma triglycerides over a 3-h period following meal intake

  5. Plasma glycerol

    Time frame: 3 hours post meal intake

    Measure of plasma glycerol over a 3-h period following meal intake

  6. Plasma free fatty acids

    Time frame: 3 hours

    Measure of plasma free fatty acids over a 3-h period following meal intake

  7. Satiety

    Time frame: Every 30 minutes over the 3 hours post meal intake

    Satiety will be assessed by Visual Analog Scales

  8. Hunger

    Time frame: Every 30 minutes over the 3 hours post meal intake

    Hunger will be assessed by Visual Analog Scales

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Collaborators

  • Singapore Institute of Food and Biotechnology Innovation

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 7, 2016
Registry last updated
Nov 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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