Clinical trial NCT03257059: Breakfast Consumption and Its Effects on Glycemic, Insulinemic and Non-Esterified Fatty Acids Responses
Official title: Breakfast Consumption and Its Effects on Glycemic, Insulinemic and Non-Esterified Fatty Acids Responses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glycemic Response
Lead sponsor: Singapore Institute of Food and Biotechnology Innovation
Sponsor class: OTHER_GOV
Collaborators: name: General Mills
First posted: 2017-08-22
Enrollment: 13
Sex: MALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomised, crossover study with two treatments
Primary purpose: OTHER

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.

Eligibility 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.

Primary outcomes:
measure: Glycemic response
timeFrame: 1.5 days
measure: Insulin response
timeFrame: 6 hours
measure: Non-esterified fatty acids (NEFA) response
timeFrame: 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Clinical Nutrition Research Centre
Study officials:
References: