NCT03257059

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 25, 2017

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

August 9, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 22, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2019

Completed
Last Updated

May 13, 2019

Status Verified

May 1, 2019

Enrollment Period

1.7 years

First QC Date

August 9, 2017

Last Update Submit

May 10, 2019

Conditions

Glycemic Response

Outcome Measures

Primary Outcomes (3)

  • Glycemic response

    Using continuous glucose monitoring system

    1.5 days

  • Insulin response

    Postprandial after treatment

    6 hours

  • Non-esterified fatty acids (NEFA) response

    Postprandial after treatment

    6 hours

Study Arms (2)

Breakfast

EXPERIMENTAL

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

Other: Breakfast

No breakfast

EXPERIMENTAL

Subject not given breakfast to test blood glucose response

Other: No Breakfast

Interventions

BreakfastOTHER

Glutinous rice (75 grams of available carbohydrate)

Breakfast
No BreakfastOTHER

No food to be served in the morning

No breakfast

Eligibility Criteria

Age40 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Nutrition Research Centre

Singapore, 117599, Singapore

Location

MeSH Terms

Interventions

Breakfast

Intervention Hierarchy (Ancestors)

MealsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Randomised, crossover study with two treatments
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 9, 2017

First Posted

August 22, 2017

Study Start

July 25, 2017

Primary Completion

March 28, 2019

Study Completion

March 28, 2019

Last Updated

May 13, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)