NCT04228341

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable diabetes-mellitus

Timeline
Completed

Started Feb 2019

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

February 13, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 26, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 14, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2020

Completed
Last Updated

August 20, 2021

Status Verified

August 1, 2021

Enrollment Period

5 months

First QC Date

January 11, 2020

Last Update Submit

August 19, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Glucose

    Whole capillary blood glucose will be measure using Hemocue analyser

    Up to 180 minutes

Secondary Outcomes (1)

  • Insulin

    Up to 180 minutes

Study Arms (8)

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

EXPERIMENTAL

9 % polished rice

Other: 9 % polished rice

20 % Polished rice

EXPERIMENTAL

Cooked 20 % Polished rice (White Rice)

Other: 20 % Polished rice

Interventions

50 g of glucose dissolved in 250 ml of water (First glucose control visit)

Glucose Reference 1

50 g of glucose dissolved in 250 ml of water (Second glucose control visit)

Glucose Reference 2

50 g of glucose dissolved in 250 ml of water (Third glucose control visit)

Glucose Reference 3

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

Brown 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

3 % 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

6 % 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

9 % polished 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.

20 % Polished rice

Eligibility Criteria

Age21 Years - 60 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale only
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Nutrition Research Centre

Singapore, 117599, Singapore

Location

MeSH Terms

Conditions

Diabetes MellitusObesity

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

January 11, 2020

First Posted

January 14, 2020

Study Start

February 13, 2019

Primary Completion

July 26, 2019

Study Completion

June 18, 2020

Last Updated

August 20, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations