Clinical trial NCT03031886: Energy Flux and Fat Oxidation Using Low and High Glycaemic Index Foods
Official title: Energy Flux and Fat Oxidation Using Low and High Glycaemic Index Foods
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Obesity
PreDiabetes
Lead sponsor: Singapore Institute of Food and Biotechnology Innovation
Sponsor class: OTHER_GOV
First posted: 2017-01-26
Enrollment: 20
Sex: MALE
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A randomized,crossover design with either a low or high GI diet with a 5 day washout period in between the 2 interventions..
Primary purpose: OTHER

Brief summary: Purpose: This study is carried out to determine the effect of GI on 24 hour blood glucose profiles and energy regulation in Asians when fed a normal diet modulated with sweeteners.

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 and overweight, Chinese males will be recruited. There will be two sessions (consisting of three days for each session) where they will consume either a high or low glycaemic index dinner at home and a high or low GI breakfast, lunch and snack on the next day (in the whole body calorimeter). There will be 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 whether the inclusion of a low GI sweetener in a mixed meal sequence can impact blood glucose levels and energy regulation in Asians. The study is important in that it will enable us to compute the rate of fat oxidation and how it is influenced when subjects are fed a mixed meals modulated to be high GI (increased glucose excursions) or low GI (moderated 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 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 Asians.

Eligibility criteria: Inclusion Criteria:

* Chinese, male
* Age between 21-40 years
* Body mass index between 17 to 28 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)
* One prescription medication
* Partaking in sports at the competitive and/or endurance levels
* Allergic/intolerant to any of the test foods
* Intentionally restricting food intake
* Smoking

Primary outcomes:
measure: Glycaemic response
timeFrame: 3 hours post consumption
measure: Daily blood glucose profile
timeFrame: 24 hours
measure: substrate oxidation
timeFrame: 3 hours post consumption
measure: energy expenditure
timeFrame: 3 hours post consumption
Secondary outcomes:
Other outcomes:
measure: Oxygen consumption
timeFrame: 3 hours post consumption
measure: carbon dioxide production
timeFrame: 3 hours post consumption
measure: Nitrogen production
timeFrame: 10 hours
Locations:
city: Singapore
country: Singapore
facility: Clinical Nutrition Research Centre
Study officials:
References: