- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04228341
The Effect of Degree of Rice-polishing on Glycaemic Response
August 19, 2021 updated by: JeyaKumar Henry, Clinical Nutrition Research Centre, Singapore
To investigate the effects of rice polishing on glycaemic and insulinaemic response in healthy Chinese male volunteers.
Study Overview
Status
Completed
Conditions
Detailed Description
There will be a total of 8 test session.
Each session will last for 3.5 hours.
At each test session, volunteers will be served with test meal and blood will be collected.
After an overnight fast, subjects will visit the research center.
Two fasting capillary blood samples will be collected via fingerprick.
Following the fasting samples, subject will consume the test meals.
Further blood samples will be collected at 15, 30, 45, 60, 90, 120, 150, 180 minutes after the ingestion of test meal.
These samples will be used to analyses for whole capillary blood glucose.
At every 30 minute interval, samples will be collected for analysis of capillary plasma insulin.
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Singapore, Singapore, 117599
- Clinical Nutrition Research Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Male
- Chinese ethnicity
- Age ≥21 and ≤ 60 years
- Body mass index between 18.5 to 25 kg/m2
- Normal blood pressure =<140/90 mmHg
- Fasting blood glucose <6.0 mmol/L
- In general good health
Exclusion Criteria:
- Current smoker
- Have any metabolic diseases (such as diabetes, hypertension etc)
- Do not 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 intolerances or allergies to any foods
- Currently partake in sports at the competitive and/or endurance levels
- Intentionally restrict food intake
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Glucose Reference 1
Glucose solution 1
|
50 g of glucose dissolved in 250 ml of water (First glucose control visit)
|
|
Other: Glucose Reference 2
Glucose solution 2
|
50 g of glucose dissolved in 250 ml of water (Second glucose control visit)
|
|
Other: Glucose Reference 3
Glucose solution 3
|
50 g of glucose dissolved in 250 ml of water (Third glucose control visit)
|
|
Experimental: Brown Rice
Cooked brown rice
|
Unpolished brown rice containing 50 g of available carbohydrate was cooked using a rice cooker (Toyomi) at a ratio of rice to water of 1: 2
|
|
Experimental: 3 % polished rice
Cooked 3 % polished rice
|
3% polished rice, containing 50 g of available carbohydrate was cooked using a rice cooker at a ratio of rice to water of 1: 2
|
|
Experimental: 6 % polished rice
Cooked 6 % polished rice
|
6% polished rice, containing 50 g of available carbohydrate was cooked using a rice cooker at a ratio of rice to water of 1: 2
|
|
Experimental: 9 % polished rice
|
9 % polished rice, containing 50 g of available carbohydrate was cooked using a rice cooker at a ratio of rice to water of 1: 2
|
|
Experimental: 20 % Polished rice
Cooked 20 % Polished rice (White Rice)
|
White rice (20% polished rice), containing 50 g of available carbohydrate was cooked using a rice cooker at a ratio of rice to water of 1: 2.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Glucose
Time Frame: Up to 180 minutes
|
Whole capillary blood glucose will be measure using Hemocue analyser
|
Up to 180 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Insulin
Time Frame: Up to 180 minutes
|
Capillary plasma will be measure using Cobas analyser
|
Up to 180 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 13, 2019
Primary Completion (Actual)
July 26, 2019
Study Completion (Actual)
June 18, 2020
Study Registration Dates
First Submitted
January 11, 2020
First Submitted That Met QC Criteria
January 11, 2020
First Posted (Actual)
January 14, 2020
Study Record Updates
Last Update Posted (Actual)
August 20, 2021
Last Update Submitted That Met QC Criteria
August 19, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 2018/01079
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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