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

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.

Study Overview

• Status: Completed
• Conditions: Glycemic Response
• Intervention / Treatment: Other: Breakfast; Other: No Breakfast

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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 117599
    • Clinical Nutrition Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemic response	Using continuous glucose monitoring system	1.5 days
Insulin response	Postprandial after treatment	6 hours
Non-esterified fatty acids (NEFA) response	Postprandial after treatment	6 hours

Collaborators and Investigators

• Sponsor: JeyaKumar Henry
• Collaborators: General Mills

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2017
• Primary Completion (Actual): March 28, 2019
• Study Completion (Actual): March 28, 2019

Study Registration Dates

• First Submitted: August 9, 2017
• First Submitted That Met QC Criteria: August 18, 2017
• First Posted (Actual): August 22, 2017

Study Record Updates

• Last Update Posted (Actual): May 13, 2019
• Last Update Submitted That Met QC Criteria: May 10, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 2017/00537

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No