NCT03703544

Brief Summary

This study is carried out to determine the effect of high and low GI of local foods using Continuous Glucose Monitoring System (CGMS™) on 24 hour blood glucose profiles.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable diabetes

Timeline
Completed

Started Dec 2017

Typical duration for not_applicable diabetes

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 9, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 12, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 22, 2020

Completed
Last Updated

July 17, 2020

Status Verified

May 1, 2019

Enrollment Period

2.4 years

First QC Date

October 9, 2018

Last Update Submit

July 16, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Daily blood glucose profile

    The daily total blood glucose response is measured for each low and high GI treatment as the area under the curve over 24 hours using CGMS for breakfast, lunch, snack and dinner.

    24 hours

Study Arms (2)

High glycemic index

EXPERIMENTAL

Subjects will consume locally consumed meals which are high glycemic index for breakfast, lunch snack and dinner will be provided.Participants' blood glucose will be monitored using the Continuous Glucose Monitor.

Other: High glycemic index

Low glycemic index

EXPERIMENTAL

Subjects will consume locally consumed meals which are low glycemic index for breakfast, lunch snack and dinner will be provided. Participants' blood glucose will be monitored using the Continuous Glucose Monitor.

Other: Low glycemic index

Interventions

Wheat yellow noodle, glutinous rice, tea with sucrose, biscuits, jelly made with sucrose and teriyaki chicken rice.The foods provided have been tested as high glycemic index. Participants' blood glucose will be monitored using the Continuous Glucose Monitor.

High glycemic index

Beta-glucan yellow noodle, basmati rice, tea with isomaltulose, biscuits, jelly made with isomaltulose and mung bean noodles.The foods provided have been tested as low glycemic index.Participants' blood glucose will be monitored using the Continuous Glucose Monitor.

Low glycemic index

Eligibility Criteria

Age21 Years - 50 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsHealthy male participants
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Chinese, male
  • Age between 21-50 years
  • Body mass index between 18 to 25 kg/m2
  • Normal blood pressure (\<140/90 Hgmm)
  • Fasting blood glucose \< 6 mmol/L

You may not qualify if:

  • Current Smoker
  • Have any metabolic diseases (such as diabetes, hypertension etc)
  • Have known glucose-6-phosphate dehydrogenase deficiency (G6PD deficiency)
  • have medical conditions and/or taking medications known to affect glycaemia (glucocorticoids, thyroid hormones, thiazide diuretics)
  • Have an ongoing infection or currently undergoing treatment at the time of screening
  • 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)• Have active Tuberculosis (TB) or currently receiving treatment for TB
  • Have intolerances or allergies to any foods
  • Partake in sports at the competitive and/or endurance levels

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Nutrition Research Centre

Singapore, 117599, Singapore

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 9, 2018

First Posted

October 12, 2018

Study Start

December 15, 2017

Primary Completion

May 22, 2020

Study Completion

May 22, 2020

Last Updated

July 17, 2020

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations