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Breakfast Consumption and Its Effects on Glycemic, Insulinemic and Non-Esterified Fatty Acids Responses (BEGIN)

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ClinicalTrials.gov Identifier: NCT03257059
Recruitment Status : Completed
First Posted : August 22, 2017
Last Update Posted : May 13, 2019
Sponsor:
Collaborator:
General Mills Inc.
Information provided by (Responsible Party):
JeyaKumar Henry, Clinical Nutrition Research Centre, Singapore

Brief Summary:
The aim of this study is to determine whether eating breakfast or having no breakfast has subsequent beneficial health effects, specifically in relation to glycemic response throughout the day and postprandial insulin and non-esterified fatty acids (NEFA) responses 6 hours after breakfast/lunch.

Condition or disease Intervention/treatment Phase
Glycemic Response Other: Breakfast Other: No Breakfast Not Applicable

Detailed Description:
This will be a randomised, crossover study with two treatments in total. 1.) Subjects given with breakfast, 2.) Subjects not given breakfast. Each of the two test visits will last for approximately 9 hour (spanning over 3 days), during which the following will take place: On Day 1, subjects will come to have the continuous glucose monitoring (CGMS) system inserted. CGMS will be used to measure 24 hour blood glucose concentrations. On Day 2, an indwelling catheter will be inserted into the ante cubital fossa or forearm vein of one arm and will be kept patent. One fasting blood sample (baseline; 4 milliliters of venous blood) will be collected. Participants with breakfast treatment will then consume the test meal within 15 minutes. Subsequently, blood samples will be taken at 15, 30, 45, 60, 90, 120, 150 and 180 minutes.At time 180 minutes, participants will be given a standardized lunch to be consumed within 30 minutes. Blood samples will be taken after lunch at 210, 240, 270, 300, 330 and 360 minutes. On Day 3, subjects will need to come for removal of the CGMS sensor. Subjects will come to the CNRC again for the 2nd test visit, with at least 3 days wash-out in-between visits.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomised, crossover study with two treatments
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Breakfast Consumption and Its Effects on Glycemic, Insulinemic and Non-Esterified Fatty Acids Responses
Actual Study Start Date : July 25, 2017
Actual Primary Completion Date : March 28, 2019
Actual Study Completion Date : March 28, 2019

Arm Intervention/treatment
Experimental: Breakfast
Subject given standardized breakfast (glutinous rice) to test blood glucose response
Other: Breakfast
Glutinous rice (75 grams of available carbohydrate)

Experimental: No breakfast
Subject not given breakfast to test blood glucose response
Other: No Breakfast
No food to be served in the morning




Primary Outcome Measures :
  1. Glycemic response [ Time Frame: 1.5 days ]
    Using continuous glucose monitoring system

  2. Insulin response [ Time Frame: 6 hours ]
    Postprandial after treatment

  3. Non-esterified fatty acids (NEFA) response [ Time Frame: 6 hours ]
    Postprandial after treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Chinese males
  • BMI above 23.0 kg/m2
  • Age between 40-65 years
  • Normal blood pressure (<140/90 mmHg)
  • Fasting blood glucose of ≥5.6 mmol/L
  • Self-reported regular breakfast consumers

Exclusion Criteria:

  • Have known glucose-6-phosphate dehydrogenase (G6PD) deficiency
  • major chronic disease such as heart disease, cancer or diabetes mellitus
  • taking insulin or drugs known to affect glucose metabolism
  • Intentionally restrict food intake
  • major medical or surgical event requiring hospitalization within the preceding 3 months
  • Have taken antibiotics for 3 months before the study period
  • Smoking
  • Overnight shift workers
  • Any known food allergy (eg. anaphylaxis to peanuts)
  • Having active Tuberculosis (TB) or currently receiving treatment for TB
  • Any known Chronic infection or known to suffer from or have previously suffered from or is a carrier of Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV)
  • Being a member of the research team or their immediate family members. Immediate family member is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
  • Enrolled in a concurrent research study judged not to be scientifically or medically compatible with the study of the CNRC.

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): NCT03257059


Locations
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Singapore
Clinical Nutrition Research Centre
Singapore, Singapore, 117599
Sponsors and Collaborators
JeyaKumar Henry
General Mills Inc.

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Responsible Party: JeyaKumar Henry, Principal Investigator, Clinical Nutrition Research Centre, Singapore
ClinicalTrials.gov Identifier: NCT03257059     History of Changes
Other Study ID Numbers: 2017/00537
First Posted: August 22, 2017    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No