Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study to Determine Ethnic Differences in the Glycaemic Response to Nutritional Formula Drinks

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: NCT01889628
Recruitment Status : Completed
First Posted : June 28, 2013
Last Update Posted : February 2, 2016
Sponsor:
Collaborator:
Danone Research
Information provided by (Responsible Party):
Melvin Leow, Clinical Nutrition Research Centre, Singapore

Tracking Information
First Submitted Date  ICMJE June 21, 2013
First Posted Date  ICMJE June 28, 2013
Last Update Posted Date February 2, 2016
Study Start Date  ICMJE June 2013
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2013)
Glycaemic response [ Time Frame: 2-3 hours post-consumption ]
The blood glucose response to the nutritional formula drinks measured over 2-3 hours following their consumption.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Determine Ethnic Differences in the Glycaemic Response to Nutritional Formula Drinks
Official Title  ICMJE Ethnic Differences in the Glycaemic Response and Glycaemic Index to Liquid-based Nutritional Formulas Between Chinese, Malays and Indians in Singapore
Brief Summary Nutritional formula drinks are widely consumed in Asia especially by those having chronic illnesses such as diabetes. Therefore, gauging the impact of nutritional formulas on blood glucose levels is very important. Asia is home to three predominant ethnic groups- Chinese, Malay and Indians. It is still unknown if the blood glucose response to nutritional formulas differs between ethnic groups. Therefore the aim of this study is to observe if there are ethnic differences in the blood glucose response to nutritional formula drinks.
Detailed Description

Nutritional formulas are commonly consumed by individuals both to supplement their food intake and as total meal replacers. Consumption rates of nutritional formulas are increasing also in Asia. Very little is known about differences in the glycaemic response to nutritional formulas between different ethnic groups. The aim of the current study is to determine the glycaemic response (GR) and glycaemic index (GI) to three nutrition formulas in Chinese, Indian and Malay subjects.

The study will have a randomised, non-blind, between-subjects, crossover design. The subjects will return for six test sessions. At three random sessions subjects will test the reference food and on the remaining three sessions they will consume the test foods (Diasip, Isocal, Protinex). The first test session will be a glucose test session (for subjects requiring glucose tests). The reference food will be anhydrous glucose (50 g) dissolved in 250 ml of water. The test foods will be portions of the nutritional formulas containing 50 g of available carbohydrates. Subjects who have previously taken part in GI studies at the CNRC and who have already completed three reference glucose tests will have to complete only the three test food sessions. However, they may be asked to do one, two or all three of the glucose tests if their previous test results are old (> 3 months) or are not within the required precision (CV <30%). This aspect will be at the discretion of the investigator and communicated to the participant at the time of briefing (before consenting).

The primary measurement in the study will be the glycaemic response. This will be measured using finger-prick blood samples. The fingers in the non-dominant hand will be used. To encourage blood flow the hand will be warmed using warm water or a hot towel beforehand if required. The finger will then be disinfected using a sterile wipe. Blood will be obtained by finger prick using a single-use lancing device. To minimise plasma dilution fingertips will not be squeezed to extract blood but gently massaged starting from the base of the hand moving towards the tips. The first two drops of expressed blood will be discarded and the next drop (5 μL) will be used for testing. Blood glucose in the sample will be measured using the HemoCue® 201+ Glucose analyser (HemoCue Ltd, Dronfield, UK).

The participants will arrive at the laboratory between 8:30-9 am following a 10 hour overnight fast. They will be instructed not to partake in intense level sports and avoid alcohol consumption on the evening prior to a test session. Following a 10 minute rest two blood samples will be obtained five minutes apart for determining baseline blood glucose levels. If the two baseline blood glucose values are far apart a further 1-2 blood samples may be taken until two stable values are obtained. The study session will be terminated if stable values cannot be obtained or if baseline blood glucose levels are above 6 mmol/L. After obtaining acceptable baseline blood glucose values they will be given either the standard or test food to consume. They will be asked to consume the drink at a comfortable pace within 10 minutes. Further blood samples will be obtained at 15, 30, 45, 60, 90, 120, 150 and 180 minutes for blood glucose measurements. Mandatory sampling will be carried out up to 120 minutes. If the blood glucose level has not reached baseline levels by the end of 120 minutes further samples may be taken at 150 and 180 minutes. During the entire testing period the participants will be instructed to remain rested and in the laboratory.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Diabetes
  • Impaired Glucose Tolerence
Intervention  ICMJE Dietary Supplement: Liquid-based Nutritional Formulae and liquid glucose
Other Names:
  • Diasip
  • Protinex
  • Isocal
  • liquid glucose
Study Arms  ICMJE
  • Chinese ethnicity
    Three nutritional formulae (Isocal, Protinex and Diasip) and liquid glucose
    Intervention: Dietary Supplement: Liquid-based Nutritional Formulae and liquid glucose
  • Malay ethnicity
    Three liquid nutritional formulae (Isocal, Diasip and Protinex) and liquid glucose
    Intervention: Dietary Supplement: Liquid-based Nutritional Formulae and liquid glucose
  • Indian Ethnicity
    Three liquid nutritional formulae (Isocal, Diasip and Protinex) and liquid glucose
    Intervention: Dietary Supplement: Liquid-based Nutritional Formulae and liquid glucose
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 1, 2016)
52
Original Estimated Enrollment  ICMJE
 (submitted: June 27, 2013)
48
Actual Study Completion Date  ICMJE November 2015
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age between 21-40 years
  • Be of Chinese, Malay or Indian ethnic origin
  • Do not partake in sports at the competitive and/or endurance levels
  • Body mass index between 18 to 24 kg/m2
  • Normal blood pressure range (120/80 mmHg)

Exclusion Criteria:

  • Those having a fasting blood glucose concentration above 6.0 mmol/l
  • Those having metabolic or chronic diseases (Diabetes, hypertension etc)
  • Having allergies/intolerances to the foods provided in the study
  • Smoking
  • Those having medical conditions and/or taking medications known to affect glycaemia or major effects on body fat distribution (glucocorticoids, thyroid hormones, thiazide diuretics)
  • Those having gastrointestinal diseases that may interfere with digestion or nutrient absorption
  • Those who had medical or surgical events requiring hospitalization within the preceding three months
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01889628
Other Study ID Numbers  ICMJE 2013/00403
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Melvin Leow, Clinical Nutrition Research Centre, Singapore
Study Sponsor  ICMJE Clinical Nutrition Research Centre, Singapore
Collaborators  ICMJE Danone Research
Investigators  ICMJE
Principal Investigator: Melvin Leow, MBBS Singapore Institute for Clinical Sciences
PRS Account Clinical Nutrition Research Centre, Singapore
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP