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Flax Mucilage and Apparent Nutrient Digestibility (HØRFRØ)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by University of Copenhagen.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Copenhagen
ClinicalTrials.gov Identifier:
NCT00953004
First received: July 17, 2009
Last updated: November 10, 2010
Last verified: August 2009
History of Changes
  Purpose

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


Condition Intervention
Obesity
 Dietary Supplement: fiber drink and fiber bread

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Flaxseed and Flaxseed Mucilage on Energy Digestibility, Lipid Profile and Appetite

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • Fat and energy digestibility [ Time Frame: mean over period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • appetite [ Time Frame: three times daily ] [ Designated as safety issue: No ]
  • gastrointestinal distress [ Time Frame: continously ] [ Designated as safety issue: Yes ]
  • lipid profile [ Time Frame: end of each period ] [ Designated as safety issue: No ]
  • glucose and insulin [ Time Frame: end of each period ] [ Designated as safety issue: No ]
  • fecal output and transit time [ Time Frame: mean of each period ] [ Designated as safety issue: No ]

Estimated Enrollment: 16
Study Start Date: March 2009
Estimated Study Completion Date: December 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18-40y
  • BMI 22-28
  • healthy

Exclusion Criteria:

  • smoking
  • medication
  • excess PA
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00953004

Locations
Denmark
University of Copenhagen, Department og Human Nutrition
Frederiksberg C, Denmark, 1958
Sponsors and Collaborators
University of Copenhagen
Investigators
Principal Investigator: Arne Astrup, PhD, Dr med University of Copenhagen
  More Information

No publications provided

Responsible Party: Head and professor Arne Astrup, University of Copenhagen, Department of Human Nutrition
ClinicalTrials.gov Identifier: NCT00953004     History of Changes
Other Study ID Numbers: B245
Study First Received: July 17, 2009
Last Updated: November 10, 2010
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by University of Copenhagen:
dietary fiber
obesity
apparent energy digestibility

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013