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CompletedNCT03309254Updated Oct 12, 2018

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

An interventional study of High Glycemic Index and Low Glycemic Index in Pre Diabetes, sponsored by Singapore Institute of Food and Biotechnology Innovation. Completed at 1 site in Singapore. Open to female participants aged 23 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-12.

Sponsored by Singapore Institute of Food and Biotechnology Innovation · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
23 Years to 70 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

03

Who can participate

Ages eligible
23 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
46 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • OtherHigh Glycemic Index

    High Glycemic Index Food

  • OtherLow Glycemic Index

    Low Glycemic Index Food

05

What researchers measure

Primary outcomes

  1. Glycemic response

    measured using continuous glucose monitoring system

    Time frame: up to 8 hours

  2. Glycemic response

    measured using COBAS Analyzer

    Time frame: up to 4 hours

Secondary outcomes

  1. Blood Biochemistry

    measured using COBAS Analyzer

    Time frame: up to 4 hours

  2. Respiratory quotient and fat oxidation

    measured using indirect calorimeter

    Time frame: up to 4 hours

06

Study locations

1 site
  • Clinical Nutrition Research Centre
    Singapore, 117599, Singapore
07

References and documents

Publications

  • 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. PubMed 30391694 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03309254
Lead sponsor
Singapore Institute of Food and Biotechnology Innovation
Collaborators
University of Auckland, New Zealand, Massey University, Riddet University
Responsible party
JeyaKumar Henry (Principal Investigator, Singapore Institute of Food and Biotechnology Innovation) — Principal investigator
First posted
Oct 13, 2017
Start date
Jan 18, 2016
Primary completion
Mar 23, 2018
Completion
Mar 23, 2018
Last update
Oct 12, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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