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

NCT ID: NCT03257059

Last Updated: 2019-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-25
• Study Completion Date: 2019-03-28

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.

Conditions

Glycemic Response

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Breakfast

Subject given standardized breakfast (glutinous rice) to test blood glucose response

Group Type: EXPERIMENTAL

Breakfast

Intervention Type: OTHER

Glutinous rice (75 grams of available carbohydrate)

No breakfast

Subject not given breakfast to test blood glucose response

Group Type: EXPERIMENTAL

No Breakfast

Intervention Type: OTHER

No food to be served in the morning

Interventions

Breakfast

Glutinous rice (75 grams of available carbohydrate)

Intervention Type: OTHER

No Breakfast

No food to be served in the morning

Intervention Type: OTHER

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

General Mills

INDUSTRY

Sponsor Role: collaborator

JeyaKumar Henry

OTHER_GOV

Sponsor Role: lead

Responsible Party

JeyaKumar Henry

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Clinical Nutrition Research Centre

Singapore, , Singapore

Countries

Singapore

Other Identifiers

2017/00537

Identifier Type: -

Identifier Source: org_study_id