NCT02380846

Brief Summary

This study aims to find out how consuming different proteins with rice affect metabolism. Most meals the investigators eat predominantly consist of a carbohydrate and protein (i.e. rice, noodles, bread etc with meats or seafood). However, it is still unknown how consuming different proteins with commonly eaten carbohydrates affect metabolism. Previous studies have shown that proteins stimulate hormones such as insulin, glucagon and gut hormones. However, the extent of the response depends on protein type. The metabolic responses to carbohydrates have also been shown to be greatly affected when they are eaten with proteins. However, most of the previous studies have used glucose as the carbohydrate and it is still unknown how eating proteins with carbohydrate foods such as rice affect metabolism. Therefore, this study has been initiated to determine the metabolic effects of eating different protein types with rice. Using the most common carbohydrate eaten in Asia (rice) and four commonly eaten protein foods (egg, chicken, fish and beancurd), this study aims to observe the metabolic effects of co-ingesting proteins and carbohydrate. The resulting data will provide valuable insights into the metabolic effects of protein-carbohydrate meals and will be useful in the development of practical advice and dietary guidelines for those with chronic diseases (such as diabetes and obesity).

Trial Health

100
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

Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable

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

September 1, 2013

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 28, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 5, 2015

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 8, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 8, 2018

Completed
Last Updated

May 15, 2019

Status Verified

May 1, 2019

Enrollment Period

5.1 years

First QC Date

January 28, 2015

Last Update Submit

May 14, 2019

Conditions

Outcome Measures

Primary Outcomes (3)

  • Blood glucose response (incremental area under the curve) measured using the hemocue

    Blood glucose response (incremental area under the curve) measured using the hemocue

    3.5 hours post consumption

  • Insulin (incremental area under the curve) is determined using the COBAS

    Insulin (incremental area under the curve) is determined using the COBAS

    3.5 hours post consumption

  • Glucagon determined using the ELISA

    Glucagon is determined using the ELISA

    3.5 hours post consumption

Secondary Outcomes (2)

  • Effects of physical activity

    Assessed at the start of every test session 1-2 weekly and up to 8 weeks in total per subject.

  • Satiety: Hunger and fullness measured using the Visual analogue scale

    Assessed at the start of every test session 1-2 weekly and up to 8 weeks in total per subject.

Study Arms (5)

Rice

OTHER

Control session - white rice (equivalent to 50g available carbohydrates)

Other: White rice

Rice with chicken

ACTIVE COMPARATOR

Treatment 1 - White rice and steamed chicken breast (25g protein)

Other: Rice with chicken breast

Rice with fish

ACTIVE COMPARATOR

Treatment 2 - White rice and steamed fish (25g protein)

Other: Rice with fish

Rice with egg white

ACTIVE COMPARATOR

Treatment 3 - White rice and egg white (25g protein)

Other: Rice with egg white

Rice with beancurd

ACTIVE COMPARATOR

Treatment 4 - White rice and steamed beancurd (25g protein)

Other: Rice with beancurd

Interventions

Control - white rice

Rice

Treatment 1 - steamed white rice with steamed chicken breast

Rice with chicken

Treatment 2 - steamed white rice with steamed fish

Rice with fish

Treatment 3 - steamed white rice with egg white

Rice with egg white

Treatment 4 - steamed white rice with steamed beancurd

Rice with beancurd

Eligibility Criteria

Age21 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Chinese ethnicity
  • Male
  • Age between 21-40 years
  • Do not have any metabolic diseases (diabetes, hypertension etc)
  • Do not have G6PD deficiency
  • Not on prescription medication known to affect glucose related metabolism
  • Not allergic/intolerant to any of the test foods
  • Do not partake in sports at the competitive and/or endurance levels
  • Weight of at least 45kg
  • Body mass index between 18.0 to 24.9 kg/m2
  • Normal blood pressure (120/80 mmHg)
  • Fasting blood glucose \<6.0 mmol/L

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Metabolic Diseases

Interventions

In Situ Hybridization, FluorescenceEgg White

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

In Situ HybridizationStaining and LabelingHistocytological Preparation TechniquesCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesInvestigative TechniquesCytogenetic AnalysisGenetic TechniquesNucleic Acid HybridizationEggsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

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

January 28, 2015

First Posted

March 5, 2015

Study Start

September 1, 2013

Primary Completion

October 8, 2018

Study Completion

October 8, 2018

Last Updated

May 15, 2019

Record last verified: 2019-05