Effect of Different Flour Compositions in a Carbohydrate-... | NCT01734590

Studies
Effect of Different Flour Compositions in a Carbohydrate-based Food on Rate of Exogenous Glucose Appearance in Blood

NCT01734590

Sponsor

Unilever R&D

Status

Completed

Last Update Posted

Jun 19, 2013Estimated

Enrollment

12Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

Carbohydrate based food mix 1
Carbohydrate based food mix 2
Control carbohydrate based food

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2012

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Nov 21, 2012

First Submission Date that Met QC Criteria

Nov 26, 2012

First Posted Date

Nov 27, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 18, 2013

Last Update Posted Date

Jun 19, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Twelve volunteers will participate in the study; each person will be studied on three different occasions at least one week apart, consuming the three different test products in a randomized order. Test products are carbohydrate-based food made from different flour mixes differing in their expected rate of intestinal starch digestion. The products are labeled with 13C starch.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Carbohydrate based food mix 1	Experimental	Slowly digestible carbohydrate	Dietary Supplement: Carbohydrate based food mix 2 Dietary Supplement: Control carbohydrate based food
Carbohydrate based food mix 2	Experimental	Slowly digestible carbohydrate	Dietary Supplement: Carbohydrate based food mix 1 Dietary Supplement: Control carbohydrate based food
Control carbohydrate based food	Active Comparator	Rapidly digestible carbohydrate	Dietary Supplement: Carbohydrate based food mix 1 Dietary Supplement: Carbohydrate based food mix 2

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Carbohydrate based food mix 1	Dietary Supplement	Carbohydrate based food	Carbohydrate based food mix 2 Control carbohydrate based food

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of appearance of exogenous glucose (RaE) based on the dual isotope technique.		Measured during 360 min for 3 periods

Secondary Outcomes

Measure	Description	Time Frame
Total blood glucose and insulin		Measured during 360 min for 3 periods

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Khalid Abd-Elaziz	QPS Netherlands BV	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
QPS		Groningen	Hanzeplein 1	9713 GZ	Netherlands