Flax Mucilage and Apparent Nutrient Digestibility (HØRFRØ)

November 10, 2010 updated by: University of Copenhagen

Effect of Flaxseed and Flaxseed Mucilage on Energy Digestibility, Lipid Profile and Appetite

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

A 3 times 1-wk randomised crossover dietary intervention study, where the full diet is provided to 17 young subjects along with different flaxseed mucilage preparations. During the last five days, fecal samples are collected. Fasting blood samples are collected on day 1 and 8 in each period and appetite sensation is registered three times daily before the main meals.

Study Type

Interventional

Enrollment (Anticipated)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Frederiksberg C, Denmark, 1958
        • University of Copenhagen, Department og Human Nutrition

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18-40y
  • BMI 22-28
  • healthy

Exclusion Criteria:

  • smoking
  • medication
  • excess PA

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: fiber drink
Dietary supplement: fiber drink and fiber bread
fiber drink or fiber bread three times daily
Experimental: fiber bread
Dietary supplement: fiber drink and fiber bread
fiber drink or fiber bread three times daily
Experimental: placebo
Dietary supplement: fiber drink and fiber bread
fiber drink or fiber bread three times daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fat and energy digestibility
Time Frame: mean over period
mean over period

Secondary Outcome Measures

Outcome Measure
Time Frame
appetite
Time Frame: three times daily
three times daily
gastrointestinal distress
Time Frame: continously
continously
lipid profile
Time Frame: end of each period
end of each period
glucose and insulin
Time Frame: end of each period
end of each period
fecal output and transit time
Time Frame: mean of each period
mean of each period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Investigators

  • Principal Investigator: Arne Astrup, PhD, Dr med, University of Copenhagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

July 1, 2009

Study Completion (Anticipated)

December 1, 2009

Study Registration Dates

First Submitted

July 17, 2009

First Submitted That Met QC Criteria

August 5, 2009

First Posted (Estimate)

August 6, 2009

Study Record Updates

Last Update Posted (Estimate)

November 11, 2010

Last Update Submitted That Met QC Criteria

November 10, 2010

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B245

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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