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

Primary Purpose

Pre Diabetes

Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
High Glycemic Index
Low Glycemic Index
Sponsored by
Clinical Nutrition Research Centre, Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pre Diabetes

Eligibility Criteria

23 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Clinical Nutrition Research Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

High Glycemic Index

Low Glycemic Index

Arm Description

White Bread with Turkey breast meat (2 slices) Turkey Breast (7 slices) Chamomile Tea with 25 grams glucose Almonds 15 grams

Multi-grain Bread with Turkey breast meat (2 slices) Turkey Breast (6 slices) Chamomile Tea with 25 grams fructose Cashews 10 grams

Outcomes

Primary Outcome Measures

Glycemic response
measured using continuous glucose monitoring system
Glycemic response
measured using COBAS Analyzer

Secondary Outcome Measures

Blood Biochemistry
measured using COBAS Analyzer
Respiratory quotient and fat oxidation
measured using indirect calorimeter

Full Information

First Posted
October 10, 2017
Last Updated
October 11, 2018
Sponsor
Clinical Nutrition Research Centre, Singapore
Collaborators
University of Auckland, New Zealand, Massey University, Riddet University
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1. Study Identification

Unique Protocol Identification Number
NCT03309254
Brief Title
Role of Glycaemic Index and High Protein Meal in Response of Blood Biomarkers for Pre-diabetes
Official Title
Role of Glycaemic Index and High Protein Meal in Response of Blood Biomarkers for Pre-diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
January 18, 2016 (Actual)
Primary Completion Date
March 23, 2018 (Actual)
Study Completion Date
March 23, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clinical Nutrition Research Centre, Singapore
Collaborators
University of Auckland, New Zealand, Massey University, Riddet University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre Diabetes

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized crossover study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Glycemic Index
Arm Type
Experimental
Arm Description
White Bread with Turkey breast meat (2 slices) Turkey Breast (7 slices) Chamomile Tea with 25 grams glucose Almonds 15 grams
Arm Title
Low Glycemic Index
Arm Type
Experimental
Arm Description
Multi-grain Bread with Turkey breast meat (2 slices) Turkey Breast (6 slices) Chamomile Tea with 25 grams fructose Cashews 10 grams
Intervention Type
Other
Intervention Name(s)
High Glycemic Index
Intervention Description
High Glycemic Index Food
Intervention Type
Other
Intervention Name(s)
Low Glycemic Index
Intervention Description
Low Glycemic Index Food
Primary Outcome Measure Information:
Title
Glycemic response
Description
measured using continuous glucose monitoring system
Time Frame
up to 8 hours
Title
Glycemic response
Description
measured using COBAS Analyzer
Time Frame
up to 4 hours
Secondary Outcome Measure Information:
Title
Blood Biochemistry
Description
measured using COBAS Analyzer
Time Frame
up to 4 hours
Title
Respiratory quotient and fat oxidation
Description
measured using indirect calorimeter
Time Frame
up to 4 hours

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
All female subjects
Minimum Age & Unit of Time
23 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Clinical Nutrition Research Centre
City
Singapore
ZIP/Postal Code
117599
Country
Singapore

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30391694
Citation
Camps SG, Koh HR, Wang NX, Henry CJ. High fructose consumption with a high-protein meal is associated with decreased glycemia and increased thermogenesis but reduced fat oxidation: A randomized controlled trial. Nutrition. 2019 Feb;58:77-82. doi: 10.1016/j.nut.2018.06.024. Epub 2018 Jul 20.
Results Reference
derived

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

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