The Glycaemic Response of Local Foods Using the Continuous Glucose Monitoring System
1 other identifier
interventional
15
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable diabetes
Started Dec 2017
Typical duration for not_applicable diabetes
1 active site
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
CompletedFirst Submitted
Initial submission to the registry
October 9, 2018
CompletedFirst Posted
Study publicly available on registry
October 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 22, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 22, 2020
CompletedJuly 17, 2020
May 1, 2019
2.4 years
October 9, 2018
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
EXPERIMENTALSubjects 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.
Low glycemic index
EXPERIMENTALSubjects 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.
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.
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.
Eligibility Criteria
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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