NCT01833689

Brief Summary

The objective of this study is to assess the effect that dietary carbohydrates have on blood sugar by measuring the glycaemic index. The glycaemic index is a comparison between the effect of equal amounts of carbohydrate from a test food compared to a standard (in this case glucose) on blood sugar. Different foods that contain different carbohydrates have different effects on blood sugars. This is of interest as a number of studies have shown that the level of sugar in the blood after a meal relates directly to the risk of developing heart disease and diabetes. The aim of collecting this data is to be able to give advice to people about the carbohydrates they eat to reduce the risk of diabetes and heart disease.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jun 2013

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

April 12, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 17, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
11.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

11.8 years

First QC Date

April 12, 2013

Last Update Submit

August 10, 2023

Conditions

Keywords

glucose responseglycaemic index

Outcome Measures

Primary Outcomes (1)

  • glycaemic index

    1-2 months depending on product

Study Arms (2)

food consumption: control

PLACEBO COMPARATOR

The control product will be 50g glucose powder dissolved in 250ml of water

Dietary Supplement: food consumption

food consumption: product

ACTIVE COMPARATOR

The test food will provide 50g of available carbohydrate

Dietary Supplement: food consumption

Interventions

food consumptionDIETARY_SUPPLEMENT

Reference food The reference food is 50 g glucose powder dissolved in 250ml water Test foods The test foods are prepared according to manufacturer's instructions, representing the food as normally consumed. The test foods are consumed once only on separate occasions as a portion providing 50g of available carbohydrate. Breakfast cereals should be consumed with 150 ml milk which is additional to the 50 g available carbohydrate in the cereal. In testing breakfast cereals, the reference food must also be consumed with an additional 150 ml milk.

food consumption: controlfood consumption: product

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI 18.5-27 kg/m2
  • age 18-65 years
  • healthy

You may not qualify if:

  • diabetes
  • chronic disease
  • glucose impairment
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NIHR/Wellcome Trust Imperial CRF

London, W12 0HS, United Kingdom

RECRUITING

Study Officials

  • Gary Frost, BSc SRD PhD

    Imperial College London

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gary Frost, BSc SRD PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2013

First Posted

April 17, 2013

Study Start

June 1, 2013

Primary Completion

March 1, 2025

Study Completion

March 1, 2025

Last Updated

August 14, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations