The Effect of Degree of Rice-polishing on Glycaemic Response | NCT04228341

Studies
The Effect of Degree of Rice-polishing on Glycaemic Response

NCT04228341

Sponsor

Singapore Institute of Food and Biotechnology Innovation

Status

Completed

Last Update Posted

Aug 20, 2021Actual

Enrollment

14Actual

Phase

Not Applicable

Conditions

Diabetes Mellitus
Obesity

Interventions

Glucose Reference 1
Glucose Reference 2
Glucose Reference 3
Brown Rice
3 % polished rice
6 % polished rice
9 % polished rice
20 % Polished rice

Countries

Singapore

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 13, 2019Actual

Primary Completion Date

Jul 26, 2019Actual

Completion Date

Jun 18, 2020Actual

First Submitted Date

Jan 11, 2020

First Submission Date that Met QC Criteria

Jan 11, 2020

First Posted Date

Jan 14, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 19, 2021

Last Update Posted Date

Aug 20, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

JeyaKumar Henry, Principal Investigator, Singapore Institute of Food and Biotechnology InnovationPrincipal Investigator

Lead Sponsor

Singapore Institute of Food and Biotechnology InnovationOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To investigate the effects of rice polishing on glycaemic and insulinaemic response in healthy Chinese male volunteers.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

14Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Glucose Reference 1	Other	Glucose solution 1	Other: Glucose Reference 1
Glucose Reference 2	Other	Glucose solution 2	Other: Glucose Reference 2
Glucose Reference 3	Other	Glucose solution 3	Other: Glucose Reference 3
Brown Rice	Experimental	Cooked brown rice	Other: Brown Rice
3 % polished rice	Experimental	Cooked 3 % polished rice	Other: 3 % polished rice
6 % polished rice	Experimental	Cooked 6 % polished rice	Other: 6 % polished rice
9 % polished rice

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Glucose Reference 1	Other	50 g of glucose dissolved in 250 ml of water (First glucose control visit)	Glucose Reference 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Glucose	Whole capillary blood glucose will be measure using Hemocue analyser	Up to 180 minutes

Secondary Outcomes

Measure	Description	Time Frame
Insulin	Capillary plasma will be measure using Cobas analyser	Up to 180 minutes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

Male only

Minimum Age

21 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Nutrition Research Centre		Singapore		117599	Singapore

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus
D009765	Obesity

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

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Browse Branches

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