NCT00953004

Brief Summary

The aim is to study the effects of flaxseed mucilage, rich in dietary fiber on apparent fat and energy digestibility in young adults.

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
16

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Mar 2009

Shorter than P25 for not_applicable obesity

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

Study Start

First participant enrolled

March 1, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

July 17, 2009

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 6, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

November 11, 2010

Status Verified

August 1, 2009

Enrollment Period

4 months

First QC Date

July 17, 2009

Last Update Submit

November 10, 2010

Conditions

Obesity

Keywords

dietary fiberobesityapparent energy digestibility

Outcome Measures

Primary Outcomes (1)

  • Fat and energy digestibility

    mean over period

Secondary Outcomes (5)

  • appetite

    three times daily

  • gastrointestinal distress

    continously

  • lipid profile

    end of each period

  • glucose and insulin

    end of each period

  • fecal output and transit time

    mean of each period

Study Arms (3)

fiber drink

EXPERIMENTAL
Dietary Supplement: fiber drink and fiber bread

fiber bread

EXPERIMENTAL
Dietary Supplement: fiber drink and fiber bread

placebo

EXPERIMENTAL
Dietary Supplement: fiber drink and fiber bread

Interventions

fiber drink and fiber breadDIETARY_SUPPLEMENT

fiber drink or fiber bread three times daily

fiber breadfiber drinkplacebo

Eligibility Criteria

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

You may qualify if:

  • BMI 22-28
  • healthy

You may not qualify if:

  • smoking
  • medication
  • excess PA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Copenhagen, Department og Human Nutrition

Frederiksberg C, 1958, Denmark

Location

Related Publications (1)

  • Kristensen M, Jensen MG, Aarestrup J, Petersen KE, Sondergaard L, Mikkelsen MS, Astrup A. Flaxseed dietary fibers lower cholesterol and increase fecal fat excretion, but magnitude of effect depend on food type. Nutr Metab (Lond). 2012 Feb 3;9:8. doi: 10.1186/1743-7075-9-8.

    PMID: 22305169DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Arne Astrup, PhD, Dr med

    University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 17, 2009

First Posted

August 6, 2009

Study Start

March 1, 2009

Primary Completion

July 1, 2009

Study Completion

December 1, 2009

Last Updated

November 11, 2010

Record last verified: 2009-08

Locations

DK(1)