The Influence of Glucose Flux on Fat Synthesis in a Whole Body Calorimeter

August 1, 2017 updated by: JeyaKumar Henry, Clinical Nutrition Research Centre, Singapore

The Impact of a Low Glycaemic Index (GI) Diet on Daily Blood Glucose Profiles and Energy Flux in Male Chinese Adults.

The study is carried out to find out the inclusion of high and low glycaemic index foods to daily meals and how they impact 24 hour blood glucose fluctuations and energy regulation.

Study Overview

Status

Completed

Detailed Description

The GI is a method of classifying foods based on the food's ability to raise the blood glucose level. Low GI foods are recommended as they have a lower impact on blood glucose concentrations. The research sets out to determine the effect of GI on 24 hour blood glucose profiles and energy regulation in Asians. Healthy, normal-weight, Chinese males will be recruited. There will be two sessions (consisting of four days for each session) where they will consume either a high or low GI breakfast, lunch, snack (in the whole body calorimeter), and a high or low glycaemic index dinner at home. They will take part in two test sessions (each spanning over 3 days) with at least five days in between the two sessions. Their glycaemic response will be measured using a Continuous Glucose Monitoring System (CGMS) throughout the period, while substrate oxidation will be measured over 10 hours in the calorimeter (from breakfast, lunch and snack). This study specifically attempts to see how having high and low GI meals impact on blood glucose levels and energy regulation in Asians. The study is important in that it will be the first of its kind in the whole body calorimeter and enable us to compute the rate of fat synthesis and how it is modulated when subjects are fed a high GI diet (increased glucose excursions) and a low GI diet ( blunted glucose) over 24 hours in healthy Asians. Obesity and diabetes rates are increasing exponentially in Asian populations and Singapore is no exception. Devising ways and means to staunch the escalation is therefore a priority. The findings of the research will contribute towards the long-term objectives of developing Asian specific dietary guidelines for weight and glycaemic control. The study data will also be important for the provision of practical food-based advocacy for better weight and glycaemic control in Singaporeans.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Chinese, male
  • Age between 21-40 years
  • Body mass index between 17 to 25 kg/m2
  • Normal blood pressure (<140/80 Hgmm)
  • Fasting blood glucose < 6 mmol/L

Exclusion Criteria:

  • Having any metabolic diseases (such as diabetes, hypertension etc)
  • On prescription medication
  • Having glucose 6-phosphate dehydrogenase deficiency (G6PD)
  • Partaking in sports at the competitive and/or endurance levels
  • Allergic/intolerant to any of the test foods
  • Intentionally restricting food intake
  • Smoking

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Breakfast, lunch, snack and dinner (high GI)
Subjects will consume meals which are high glycemic index for breakfast (Honey stars cereal), lunch (glutinous rice meal) and snack (white bread and jam) in the whole body calorimeter. A take-away high glycemic index dinner will be provided.
These meals (cereal, rice and bread meals) will be tested in subjects for their glycaemic response (CGMS) and substrate utilization (calorimeter)
Experimental: Breakfast, lunch, snack and dinner (low GI)
Subjects will consume meals which are low glycemic index for breakfast (All bran cereal), lunch (basmati rice meal) and snack (multigrain bread and sugar-free jam) in the whole body calorimeter. A take-away low glycemic index dinner will be provided.
These meals (cereal, rice and bread meals) will be tested in subjects for their glycaemic response (CGMS) and substrate utilization (calorimeter)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Daily blood glucose profile
Time Frame: 24 hours
The daily total blood glucose response is measured for each low and high GI treatment as the area under the curve over 24 hours using CGMS for breakfast, lunch, snack and dinner.
24 hours
Glycaemic response The blood glucose response to low and high GI test foods measured 2 hours post consumption using the Continuous Glucose Monitoring System (CGMS)
Time Frame: 2 hours post consumption

The blood glucose response to low and high GI test foods measured 2 hours post consumption using the Continuous Glucose Monitoring System (CGMS)

The blood glucose response to low and high GI test foods measured 2 hours post consumption using the Continuous Glucose Monitoring System (CGMS)

2 hours post consumption
Substrate oxidation
Time Frame: 2 hours post consumption
The carbohydrate and fat oxidation (i.e Respiratory Quotient) after consumption of low and high GI test foods measured 2 hours post consumption using indirect calorimetry in a whole body calorimeter. This is done over 10 hours in the whole body calorimeter measured for breakfast, lunch and snack only
2 hours post consumption

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2014

Primary Completion (Actual)

July 31, 2017

Study Completion (Actual)

July 31, 2017

Study Registration Dates

First Submitted

December 11, 2015

First Submitted That Met QC Criteria

December 11, 2015

First Posted (Estimate)

December 15, 2015

Study Record Updates

Last Update Posted (Actual)

August 2, 2017

Last Update Submitted That Met QC Criteria

August 1, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 2014/00960

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to share data

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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