NCT01734590

Brief Summary

Exploratory study with double-blind, randomized, placebo-controlled, full cross-over design. The main objective is to identify one or two flour compositions in a carbohydrate-based food that produce a significant difference (alpha =0.2) in the time to reach 50% of cumulative absorption of exogenous glucose compared to the control.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Nov 2012

Shorter than P25 for not_applicable healthy

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

November 1, 2012

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

November 21, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 27, 2012

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

June 19, 2013

Status Verified

June 1, 2013

Enrollment Period

1 month

First QC Date

November 21, 2012

Last Update Submit

June 18, 2013

Conditions

Healthy

Keywords

Flour,carbohydrate,digestibilitysubjects

Outcome Measures

Primary Outcomes (1)

  • Rate of appearance of exogenous glucose (RaE) based on the dual isotope technique.

    Measured during 360 min for 3 periods

Secondary Outcomes (1)

  • Total blood glucose and insulin

    Measured during 360 min for 3 periods

Study Arms (3)

Carbohydrate based food mix 1

EXPERIMENTAL

Slowly digestible carbohydrate

Dietary Supplement: Carbohydrate based food mix 2Dietary Supplement: Control carbohydrate based food

Carbohydrate based food mix 2

EXPERIMENTAL

Slowly digestible carbohydrate

Dietary Supplement: Carbohydrate based food mix 1Dietary Supplement: Control carbohydrate based food

Control carbohydrate based food

ACTIVE COMPARATOR

Rapidly digestible carbohydrate

Dietary Supplement: Carbohydrate based food mix 1Dietary Supplement: Carbohydrate based food mix 2

Interventions

Carbohydrate based food mix 1DIETARY_SUPPLEMENT

Carbohydrate based food

Also known as: Slowly digestible carbohydrate
Carbohydrate based food mix 2Control carbohydrate based food
Carbohydrate based food mix 2DIETARY_SUPPLEMENT

Carbohydrate based food

Also known as: Slowly digestible carbohydrate
Carbohydrate based food mix 1Control carbohydrate based food
Control carbohydrate based foodDIETARY_SUPPLEMENT

Carbohydrate based food

Also known as: Rapidly digestible carbohydrate
Carbohydrate based food mix 1Carbohydrate based food mix 2

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
* healthy males * Age at start of the study ≥18 and ≤ 50 years * Not smoking * Body mass index (BMI) ≥ 20 and ≤ 28 kg/m2 * Fasting blood glucose value of volunteer is ≥ 3.4 and ≤ 6.1 mmol/litre (i.e. 62-110 mg/dl) at screening

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

QPS

Groningen, Hanzeplein 1, 9713 GZ, Netherlands

Location

Study Officials

  • Khalid Abd-Elaziz

    QPS Netherlands BV

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2012

First Posted

November 27, 2012

Study Start

November 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

June 19, 2013

Record last verified: 2013-06

Locations

NL(1)