Flaxseed Mucilage and Satiety | NCT01238744

Studies
Flaxseed Mucilage and Satiety

NCT01238744

Sponsor

University of Copenhagen

Status

Unknown status

Last Update Posted

Nov 11, 2010Estimated

Enrollment

45Actual

Phase

Not Applicable

Conditions

Appetite

Interventions

Flaxseed drink
Flaxseed drink
Flaxseed tablet
Control drink

Countries

Not provided

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

Aug 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2009

Primary Completion Date

Aug 2010Actual

Completion Date

Dec 2010Estimated

First Submitted Date

Nov 10, 2010

First Submission Date that Met QC Criteria

Nov 10, 2010

First Posted Date

Nov 11, 2010Estimated

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

Nov 10, 2010

Last Update Posted Date

Nov 11, 2010Estimated

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

The effect of a single dose of flaxseed mucilage incorporated into either drinks or tablets will be tested in term of their effect on appetite sensation measured using visual analogue scales over 120 minutes and ad libitum energy intake hereafter in two studies.

Detailed Description

Study I:

Control drink vs. Flaxseed drink consumed and appetite sensation registered over 120 minutes. Hereafter energy intake was measured.

Study II:

Flaxseed drink vs. Flaxseed tablets+control drink consumed and appetite sensation registered over 120 minutes. Hereafter energy intake was measured.

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

45Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Study I: control drink	Placebo Comparator	Dietary Supplement: Control drink
Study I: flaxseed drink	Experimental	Dietary Supplement: Flaxseed drink
Study II: flaxseed drink	Active Comparator	Dietary Supplement: Flaxseed drink
Study II: flaxseed tablets	Experimental	Dietary Supplement: Flaxseed tablet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Flaxseed drink	Dietary Supplement	Drink containing flaxseed mucilage	Study I: flaxseed drink

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Appetite sensation	Appetite sensation measured by visual analogue scales	120 minutes

Secondary Outcomes

Measure	Description	Time Frame
Energy intake	Ad libitum energy intake at the next meal	120 minutes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy adults
18-40 years
BMI 19-28

Exclusion Criteria:

smoking
pregnancy or lactation
excessive exercise
medication (oral contraceptives the only exception)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008043	Linseed Oil

Ancestor Terms

ID	Term
D005224	Fats, Unsaturated
D005223	Fats
D008055	Lipids
D010938	Plant Oils
D009821

Browse Leaves

Not provided

Browse Branches

Not provided