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Role of Glycaemic Index and High Protein Meal in Response of Blood Biomarkers for Pre-diabetes

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: NCT03309254
Recruitment Status : Completed
First Posted : October 13, 2017
Last Update Posted : October 12, 2018
Sponsor:
Collaborators:
University of Auckland, New Zealand
Massey University
Riddet University
Information provided by (Responsible Party):
JeyaKumar Henry, Clinical Nutrition Research Centre, Singapore

Brief Summary:
This study aims to demonstrate the effectiveness of increased protein ingestion, particularly when coupled with a low glycaemic index (GI) to reduce biomarkers related to high risk of diabetes.

Condition or disease Intervention/treatment Phase
Pre Diabetes Other: High Glycemic Index Other: Low Glycemic Index Not Applicable

Detailed Description:
A randomized cross-over study and subjects will be randomized to take either the high GI or low GI meal. The sequence of the meal will be generated using an online randomiser generator.During screening administer informed consent.Measure height, weight, waist and hip circumference.Blood draw: Two fingerpricks, 5 minutes apart. 1 X 10ml red tube top to prepare serum. Serum and red platelets into separate microtubes. Serum will be used to analyse fasting blood glucose, lipid profile, C-Reactive Protein (CPR), insulin and apolipoprotein. Red platelets will be stored separately for DNA genotyping. During the study visits,On Day 1, subjects will come to the Centre at around 4:00 pm to have the continuous glucose monitoring (CGMS) system inserted. CGMS will be used to measure 24 hour blood glucose concentrations. The sensor records interstitial blood glucose concentrations every five minutes. This will involve the insertion of a small sensor under the skin in the abdomen, which will be carried out by using a device that produces minimal pain and discomfort.Subjects will have to wait in the laboratory for one hour after insertion for the sensor to be stabilized. After one hour the inserted CGMS sensor will be calibrated against a manual finger-prick blood glucose sample.Manual calibration using finger-prick blood samples will need to be carried out before every meal and before bed in the night. The calibrations before dinner and bed will have to be carried out by the subjects at home.Therefore, the subjects will be provided with a finger-prick blood glucose test kit to take home and instructed on how to correctly use it and measure blood glucose values. Subjects will then consume the standardised dinner at around 7pm.Subjects will be asked to fast overnight and instructed to avoid eating or drinking anything, except water, after 10pm. Subjects will arrived between 8.00am and 8.30am the following morning. Baseline blood samples will be collected. A venous cannula will be inserted and a fasting blood sample collected. Baseline basal metabolic rate will be measured using hood-ventilated indirect calorimetry for 30mins during fasting. Subjects will then consume the test meal. Further venous blood samples will be collected at regular intervals for up to 4hours postprandial. After meal, subjects will enter the hood-ventilated indirect calorimetry and measure post-prandial respiratory quotient for 4 hours. A medium GI lunch will then be provided and the subject can either stay in the centre or return to the centre 4 hours after lunch to remove the CGMS.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized crossover study
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Role of Glycaemic Index and High Protein Meal in Response of Blood Biomarkers for Pre-diabetes
Actual Study Start Date : January 18, 2016
Actual Primary Completion Date : March 23, 2018
Actual Study Completion Date : March 23, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

Arm Intervention/treatment
Experimental: High Glycemic Index
White Bread with Turkey breast meat (2 slices) Turkey Breast (7 slices) Chamomile Tea with 25 grams glucose Almonds 15 grams
Other: High Glycemic Index
High Glycemic Index Food

Experimental: Low Glycemic Index
Multi-grain Bread with Turkey breast meat (2 slices) Turkey Breast (6 slices) Chamomile Tea with 25 grams fructose Cashews 10 grams
Other: Low Glycemic Index
Low Glycemic Index Food




Primary Outcome Measures :
  1. Glycemic response [ Time Frame: up to 8 hours ]
    measured using continuous glucose monitoring system

  2. Glycemic response [ Time Frame: up to 4 hours ]
    measured using COBAS Analyzer


Secondary Outcome Measures :
  1. Blood Biochemistry [ Time Frame: up to 4 hours ]
    measured using COBAS Analyzer

  2. Respiratory quotient and fat oxidation [ Time Frame: up to 4 hours ]
    measured using indirect calorimeter



Information from the National Library of Medicine

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Ages Eligible for Study:   23 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   All female subjects
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Group 1: 55-70 years old, 5 years post-menopausal (a: healthy, b: fasting blood glucose, ≥5.1mmol/l) or
  • Group 2: 23-54 years old (a: healthy, b: fasting blood glucose, ≥5.1mmol/l)
  • Body mass index between 18 and 30 kg/m2

Exclusion Criteria:

  • Have family history of diabetes or any major chronic disease such as diabetes, heart disease or cancer
  • On prescribed medication known to affect blood glucose concentrations or major effects on body fat distribution
  • Have allergic/intolerant to any of the test foods (e.g bread, turkey breast, almond, cashew, glucose, fructose and chamomile tea.
  • Have gastrointestinal diseases that may interfere with digestion or nutrient absorption
  • Have medical or surgical events requiring hospitalization within the preceding three months
  • Currently pregnant or breastfeeding
  • Have G6PD deficiency

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03309254


Locations
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Singapore
Clinical Nutrition Research Centre
Singapore, Singapore, 117599
Sponsors and Collaborators
Clinical Nutrition Research Centre, Singapore
University of Auckland, New Zealand
Massey University
Riddet University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: JeyaKumar Henry, Principal Investigator, Clinical Nutrition Research Centre, Singapore
ClinicalTrials.gov Identifier: NCT03309254    
Other Study ID Numbers: 2015/01077
First Posted: October 13, 2017    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Prediabetic State
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia