NCT02151188

Brief Summary

This study hypothesizes that milk protein consumed together or shortly before a white rice or white bread carbohydrate meal exerts different influence on the glycaemic, insulinaemic responses.

Trial Health

87
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 diabetes

Timeline
Completed

Started Mar 2014

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 30, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

February 2, 2016

Status Verified

February 1, 2016

Enrollment Period

1.6 years

First QC Date

May 28, 2014

Last Update Submit

February 1, 2016

Conditions

DiabetesImpaired Glucose ToleranceObesity

Outcome Measures

Primary Outcomes (1)

  • Glucose response of different treatments

    The blood glucose will be measured by Hemocue 201 from finger prick. Venous blood will be collected at the same time points.

    3.5 hrs post consumption

Secondary Outcomes (1)

  • Gastric emptying rate

    2 hours post consumption

Study Arms (5)

Bread and water

OTHER

co-ingestion control session

Dietary Supplement: Bread, Soy milk and cow milkDevice: real-time ultrasonography (GE LOGIQ P5 ultrasound in CNRC)

bread with cow milk co-ingestion

EXPERIMENTAL

co-ingestion bread with cow milk

Dietary Supplement: Bread, Soy milk and cow milkDevice: real-time ultrasonography (GE LOGIQ P5 ultrasound in CNRC)

bread with soy milk co-ingestion

EXPERIMENTAL

co-ingestion bread with soy milk

Dietary Supplement: Bread, Soy milk and cow milkDevice: real-time ultrasonography (GE LOGIQ P5 ultrasound in CNRC)

preload cow milk

EXPERIMENTAL

preload cow milk 30 min, then bread

Dietary Supplement: Bread, Soy milk and cow milkDevice: real-time ultrasonography (GE LOGIQ P5 ultrasound in CNRC)

preload soy milk

EXPERIMENTAL

preload soy milk 30 min, then bread

Dietary Supplement: Bread, Soy milk and cow milkDevice: real-time ultrasonography (GE LOGIQ P5 ultrasound in CNRC)

Interventions

Bread, Soy milk and cow milkDIETARY_SUPPLEMENT

The study will examine the metabolic effects of two liquid proteins (soy milk and cow milk) with carbohydrate (bread) meals.

Bread and waterbread with cow milk co-ingestionbread with soy milk co-ingestionpreload cow milkpreload soy milk
real-time ultrasonography (GE LOGIQ P5 ultrasound in CNRC)DEVICE
Bread and waterbread with cow milk co-ingestionbread with soy milk co-ingestionpreload cow milkpreload soy milk

Eligibility Criteria

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

You may qualify if:

  • Chinese ethnicity
  • Age between 21-40 years
  • Not on prescription medication known to affect glucose and satiety related metabolism
  • 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)

You may not qualify if:

  • fasting blood glucose\>5.5 mmol/L
  • Any major medical conditions including diabetes, hypertension, cardiovascular disease, thyroid disorders
  • Allergic or intolerant to foods presented in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Nutrition Research Centre

Singapore, 117599, Singapore

Location

Related Publications (1)

  • Sun L, Tan KWJ, Han CMS, Leow MK, Henry CJ. Impact of preloading either dairy or soy milk on postprandial glycemia, insulinemia and gastric emptying in healthy adults. Eur J Nutr. 2017 Feb;56(1):77-87. doi: 10.1007/s00394-015-1059-y. Epub 2015 Oct 6.

    PMID: 26439722DERIVED

MeSH Terms

Conditions

Diabetes MellitusGlucose IntoleranceObesity

Interventions

BreadSoy MilkMilk

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesMilk SubstitutesBeveragesSoy FoodsVegetable ProductsVegetablesDairy Products

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 28, 2014

First Posted

May 30, 2014

Study Start

March 1, 2014

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

February 2, 2016

Record last verified: 2016-02

Locations

SG(1)