NCT01238744

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2009

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

Study Start

First participant enrolled

August 1, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 10, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 11, 2010

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

November 11, 2010

Status Verified

August 1, 2010

Enrollment Period

1 year

First QC Date

November 10, 2010

Last Update Submit

November 10, 2010

Conditions

Appetite

Outcome Measures

Primary Outcomes (1)

  • Appetite sensation

    Appetite sensation measured by visual analogue scales

    120 minutes

Secondary Outcomes (1)

  • Energy intake

    120 minutes

Study Arms (4)

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

Flaxseed drinkDIETARY_SUPPLEMENT

Drink containing flaxseed mucilage

Study I: flaxseed drink
Flaxseed tabletDIETARY_SUPPLEMENT

Tablets containing flaxseed mucilage consumed with a control drink

Study II: flaxseed tablets
Control drinkDIETARY_SUPPLEMENT

Control drink

Study I: control drink

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy adults
  • years
  • BMI 19-28

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Linseed Oil

Intervention Hierarchy (Ancestors)

Fats, UnsaturatedFatsLipidsPlant OilsOilsPlant PreparationsBiological ProductsComplex Mixtures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 10, 2010

First Posted

November 11, 2010

Study Start

August 1, 2009

Primary Completion

August 1, 2010

Study Completion

December 1, 2010

Last Updated

November 11, 2010

Record last verified: 2010-08