Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 74 of 748 for:    Area Under Curve AND meal

Bed and Breakfast (B&B) Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02927600
Recruitment Status : Completed
First Posted : October 7, 2016
Last Update Posted : November 13, 2017
Sponsor:
Collaborator:
Clinical Nutrition Research Centre, Singapore
Information provided by (Responsible Party):
Nestlé

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.

Condition or disease Intervention/treatment Phase
Healthy Other: Low GI Breakfast Other: High GI Breakfast Other: Low GI Dinner Other: High GI Dinner Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Impact of Low Glycemic Responses Breakfast or Dinner on Postprandial Glycemia of the Subsequent Meals
Study Start Date : September 2016
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017

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




Primary Outcome Measures :
  1. Glycemia [ Time Frame: 3 hours ]
    Incremental areas under curve (iAUC) of glycemia in the 3 hours following meal intake


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02927600


Locations
Layout table for location information
Singapore
Clinical Nutrition Research Center
Singapore, Singapore, 117599
Sponsors and Collaborators
Nestlé
Clinical Nutrition Research Centre, Singapore
Investigators
Layout table for investigator information
Principal Investigator: Christiani Jeyakumar Henry, Prof Centre for Translational Medicine

Layout table for additonal information
Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT02927600     History of Changes
Other Study ID Numbers: 15.18.NRC
First Posted: October 7, 2016    Key Record Dates
Last Update Posted: November 13, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Nestlé:
Glycemic response
Glycemic index
Meal intervention
Chinese population