We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02631083
Recruitment Status : Completed
First Posted : December 15, 2015
Last Update Posted : August 2, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Type 2 Diabetes, Obesity, Prediabetes Other: Breakfast, lunch, snack and dinner

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Impact of a Low Glycaemic Index (GI) Diet on Daily Blood Glucose Profiles and Energy Flux in Male Chinese Adults.
Actual Study Start Date : November 14, 2014
Primary Completion Date : July 31, 2017
Study Completion Date : July 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
U.S. FDA Resources

Arms and Interventions

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.
Other: 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: 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.
Other: 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)


Outcome Measures

Primary Outcome Measures :
  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


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
More Information

Responsible Party: JeyaKumar Henry, Principal Investigator, Clinical Nutrition Research Centre, Singapore
ClinicalTrials.gov Identifier: NCT02631083     History of Changes
Other Study ID Numbers: 2014/00960
First Posted: December 15, 2015    Key Record Dates
Last Update Posted: August 2, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share data

Additional relevant MeSH terms:
Prediabetic State
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases