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

JeyaKumar Henry

Status

Completed

Conditions

Glycemic Response

Treatments

Other: Breakfast

Other: No Breakfast

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03257059

2017/00537

Details and patient eligibility

About

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.

Full 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.

Enrollment

13 patients

Sex

Male

Ages

40 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.