Overview

This trial is active, not recruiting.

Condition type 2 diabetes, obesity, prediabetes
Treatment breakfast, lunch, snack and dinner
Sponsor Clinical Nutrition Research Centre, Singapore
Start date November 2014
End date August 2015
Trial size 15 participants
Trial identifier NCT02631083, 2014/00960

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking open label
Arm
(Experimental)
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.
breakfast, lunch, snack and dinner
These meals (cereal, rice and bread meals) will be tested in subjects for their glycaemic response (CGMS) and substrate utilization (calorimeter)
(Experimental)
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.
breakfast, lunch, snack and dinner
These meals (cereal, rice and bread meals) will be tested in subjects for their glycaemic response (CGMS) and substrate utilization (calorimeter)

Primary Outcomes

Measure
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
Daily blood glucose profile
time frame: 24 hours
Substrate oxidation
time frame: 2 hours post consumption

Eligibility Criteria

Male participants from 21 years up to 40 years old.

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

Additional Information

Official title The Impact of a Low Glycaemic Index (GI) Diet on Daily Blood Glucose Profiles and Energy Flux in Male Chinese Adults.
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Clinical Nutrition Research Centre, Singapore.