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Effect of Flaxseed on Lipid Uptake and Appetite

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00465036
First Posted: April 24, 2007
Last Update Posted: March 26, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Copenhagen
  Purpose
Randomized trial to test the effect of flaxseed fractions on appetite regulation and intestinal lipid absorption.

Condition Intervention
Obesity Dietary Supplement: Whole flaxseeds, flaxseed mucilage, glucomannan

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Effect of Whole Flaxseeds and Flaxseed Mucilage on Lipid Absorption, Glucose and Insulin Metabolism and Appetite Regulation

Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • TAG in chylomicrons
  • serum TAG
  • HDL, LDL and total cholesterol
  • appetite scores
  • ad libium food intake
  • appetite hormone levels

Secondary Outcome Measures:
  • free fatty acid profile
  • plasma glucose
  • plasma insulin
  • meal macronutrient composition
  • meal energy content
  • meal pleasantness

Estimated Enrollment: 18
Study Start Date: October 2006
Study Completion Date: October 2007
Detailed Description:
Randomized multiple crossover trial in 18 healthy males aged 18 to 40 years each are required to complete a total of five iso-caloric meal tests lasting approximately 8½ hours. Test meals will be given as breakfast meals, in which different fractions of flaxseeds are incorporated into baked products. Appetite will be registered using visual analogue scales during 7 hours after the test meal and a total of 10 blood samples will be drawn to evaluate TAG in chylomicrons, plasma LDL, HDL and total cholesterol, plasma TAG, insulin, glucose and appetite hormone levels. At the end of the test day an ad libitum meal will be served and food intake registered.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy males aged 18-40 years
  • Normal weight or moderately overweigh (BMI 25-30 kg/m2)

Exclusion Criteria:

  • Blood drawing/donation less than six months prior to start of the study
  • Hemoglobin concentration <8mmol/L
  • Chronic diseases (i.e. diabetes, CVD), hypertension, hyperlipidemia
  • Consumption of dietary supplements including vitamin tablets
  • Smoking
  • Excess physical activity (>10h of intense physical activity per week)
  • Medicine use (not including occasional consumption of pain killers)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00465036


Locations
Denmark
Institute of Human Nutrition
Frederiksberg C, Denmark, 1958
Sponsors and Collaborators
University of Copenhagen
Investigators
Principal Investigator: Søren Toubro, MD Institute of Human Nutrition
  More Information

ClinicalTrials.gov Identifier: NCT00465036     History of Changes
Other Study ID Numbers: KF 01 309595
B226
First Submitted: April 23, 2007
First Posted: April 24, 2007
Last Update Posted: March 26, 2009
Last Verified: March 2009

Keywords provided by University of Copenhagen:
fat absorption
fibres

Additional relevant MeSH terms:
(1-6)-alpha-glucomannan
Cathartics
Gastrointestinal Agents