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

Not Applicable

Completed

• Conditions: Glycemic Response

• Registration Number: NCT03257059
• Lead Sponsor: JeyaKumar Henry

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.

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 Timeline

• Study Start: 2017-07-25
• Study First Submitted: 2017-08-09
• Study First Submitted QC: 2017-08-18
• Study First Posted: 2017-08-22
• Primary Completion: 2019-03-28
• Study Completion: 2019-03-28
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-10
• Last Update Posted: 2019-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 13

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

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

Trial Locations

Locations (1)

Clinical Nutrition Research Centre; 🇸🇬 Singapore, Singapore