NCT02585427

Brief Summary

It is now recognized that diet plays a critical role in the etiology and management of the chronic diseases such as diabetes, obesity and cardiovascular disease. A high consumption of fat, especially saturated fat, is an established risk factor for Cardiovascular Disease.The glycaemic index (GI) is a measurement of the ability of different types of carbohydrate-based foods to raise blood glucose. The interest in low GI food as a weight management tool has been increasing. Different types of carbohydrates differ in their ability to increase postprandial blood glucose and insulin secretion, and may also modulate the effect of different fatty acids. The current study will compare the consumption of low and high GI carbohydrate with different fat saturation on postprandial glucose, insulin, and triacylglycerol responses in healthy participants. The data generated will have direct applications in public health policy and clinical nutrition management of chronic disease. The outcomes of the study will significantly contribute to the long term national goals of Singapore to manage and to reduce the incidence of chronic disease associated with the metabolic syndrome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Nov 2014

Typical duration for not_applicable healthy

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

November 1, 2014

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

October 14, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 23, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

August 2, 2016

Status Verified

August 1, 2016

Enrollment Period

1.4 years

First QC Date

October 14, 2015

Last Update Submit

August 1, 2016

Conditions

Keywords

DiabetesObesitymetabolic disorders

Outcome Measures

Primary Outcomes (3)

  • Glucose response of different treatments

    The blood glucose will be measured by finger prick and venous blood collection at the same time points

    4 hours postprandial

  • Insulin response of different treatments

    Insulin concentration will be measured by COBAS Roche analyzer e311

    4 hours postprandial

  • Triglycerides response of different treatments

    Triglycerides will be measured by COBAS Roche analyzer e411

    4 hours postprandial

Secondary Outcomes (2)

  • Active Glucagon-like peptide 1 response of different treatments

    4 hours postprandial

  • Gastric inhibitory polypeptide response of different treatments

    4 hours postprandial

Study Arms (6)

low glycemic index rice with butter

EXPERIMENTAL

50 g available low glycemic index rice cooked with 48 g butter ( equal 40 g saturated fatty acid)

Dietary Supplement: low glycemic index rice, high glycemic index rice, butter, olive oil and grapeseed oil

low glycemic index rice with olive oil

EXPERIMENTAL

50 g available low glycemic index rice cooked with 44 g olive oil ( equal 40 g monounsaturated fatty acid)

Dietary Supplement: low glycemic index rice, high glycemic index rice, butter, olive oil and grapeseed oil

low glycemic index rice with grapeseed oil

EXPERIMENTAL

50 g available low glycemic index rice cooked with 40 g grapeseed oil ( equal 40 g polyunsaturated fatty acid)

Dietary Supplement: low glycemic index rice, high glycemic index rice, butter, olive oil and grapeseed oil

high glycemic index rice with butter

EXPERIMENTAL

50 g available high glycemic index rice cooked with 48 g butter ( equal 40 g saturated fatty acid)

Dietary Supplement: low glycemic index rice, high glycemic index rice, butter, olive oil and grapeseed oil

high glycemic index rice with olive oil

EXPERIMENTAL

50 g available high glycemic index rice cooked with 44 g olive oil ( equal 40 g monounsaturated fatty acid)

Dietary Supplement: low glycemic index rice, high glycemic index rice, butter, olive oil and grapeseed oil

high glycemic index rice with grapeseed oil

EXPERIMENTAL

50 g available high glycemic index rice cooked with 40 g grapeseed oil ( equal 40 g polyunsaturated fatty acid)

Dietary Supplement: low glycemic index rice, high glycemic index rice, butter, olive oil and grapeseed oil

Interventions

high glycemic index rice with butterhigh glycemic index rice with grapeseed oilhigh glycemic index rice with olive oillow glycemic index rice with butterlow glycemic index rice with grapeseed oillow glycemic index rice with olive oil

Eligibility Criteria

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

You may qualify if:

  • Healthy Chinese male subjects aged between 21 and 40 years
  • Do not have major chronic disease such as heart disease, cancer or diabetes mellitus
  • Do not have family history of diabetes
  • Do not have intolerances or allergies to test products(wheat and milk based products)
  • Not taking insulin or drugs known to affect glucose or triglyceride levels and body fat distribution
  • Do not have major medical or surgical event requiring hospitalization within the preceding three months

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, Lim JZ, Magkos F, Henry CJ. Dietary fat and carbohydrate quality have independent effects on postprandial glucose and lipid responses. Eur J Nutr. 2018 Feb;57(1):243-250. doi: 10.1007/s00394-016-1313-y. Epub 2016 Oct 21.

MeSH Terms

Conditions

Diabetes MellitusObesityMetabolic Diseases

Interventions

ButterOlive Oil

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dietary FatsFatsLipidsDairy ProductsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesDietary Fats, UnsaturatedFats, UnsaturatedPlant OilsOils

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 14, 2015

First Posted

October 23, 2015

Study Start

November 1, 2014

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

August 2, 2016

Record last verified: 2016-08

Locations