NCT03309254

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 18, 2016

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 10, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 13, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2018

Completed
Last Updated

October 12, 2018

Status Verified

October 1, 2018

Enrollment Period

2.2 years

First QC Date

October 10, 2017

Last Update Submit

October 11, 2018

Conditions

Pre Diabetes

Outcome Measures

Primary Outcomes (2)

  • Glycemic response

    measured using continuous glucose monitoring system

    up to 8 hours

  • Glycemic response

    measured using COBAS Analyzer

    up to 4 hours

Secondary Outcomes (2)

  • Blood Biochemistry

    up to 4 hours

  • Respiratory quotient and fat oxidation

    up to 4 hours

Study Arms (2)

High Glycemic Index

EXPERIMENTAL

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

Low Glycemic Index

EXPERIMENTAL

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

High Glycemic IndexOTHER

High Glycemic Index Food

High Glycemic Index
Low Glycemic IndexOTHER

Low Glycemic Index Food

Low Glycemic Index

Eligibility Criteria

Age23 Years - 70 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsAll female subjects
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Nutrition Research Centre

Singapore, 117599, Singapore

Location

Related Publications (1)

  • 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.

    PMID: 30391694DERIVED

MeSH Terms

Conditions

Glucose Intolerance

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Randomized crossover study
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 10, 2017

First Posted

October 13, 2017

Study Start

January 18, 2016

Primary Completion

March 23, 2018

Study Completion

March 23, 2018

Last Updated

October 12, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)