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

Sponsor

JeyaKumar Henry (Other)

Overall Status

Completed

CT.gov ID

NCT03257059

Collaborator

General Mills (Industry)

Enrollment

Location

Arms

20.1

Actual Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glycemic Response	Other: Breakfast Other: No Breakfast	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

13 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Randomised, crossover study with two treatmentsRandomised, crossover study with two treatments

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Jul 25, 2017

Actual Primary Completion Date :

Mar 28, 2019

Actual Study Completion Date :

Mar 28, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 65 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Nutrition Research Centre	Singapore		Singapore	117599

Sponsors and Collaborators

JeyaKumar Henry
General Mills

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

JeyaKumar Henry, Principal Investigator, Clinical Nutrition Research Centre, Singapore

ClinicalTrials.gov Identifier:

NCT03257059

Other Study ID Numbers:

2017/00537

First Posted:

Aug 22, 2017

Last Update Posted:

May 13, 2019

Last Verified:

May 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of May 13, 2019