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Completed

NCT Number: NCT02631083

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Breakfast, lunch, snack and dinner

Other

These meals (cereal, rice and bread meals) will be tested in subjects for their glycaemic response (CGMS) and substrate utilization (calorimeter)

Primary outcomes

  1. 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. 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.

  3. 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

Sponsors and collaborators

Lead sponsor

Singapore Institute of Food and Biotechnology Innovation

Other Gov

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Dec 15, 2015
Registry last updated
Aug 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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