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Effect of Flaxseed on Lipid Uptake and Appetite

This study has been completed.
Sponsor:
Information provided by:
University of Copenhagen
ClinicalTrials.gov Identifier:
NCT00465036
First received: April 23, 2007
Last updated: March 25, 2009
Last verified: March 2009
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Effect of Whole Flaxseeds and Flaxseed Mucilage on Lipid Absorption, Glucose and Insulin Metabolism and Appetite Regulation

Resource links provided by NLM:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 40 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00465036     History of Changes
Other Study ID Numbers: KF 01 309595, B226
Study First Received: April 23, 2007
Last Updated: March 25, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Copenhagen:
fat absorption
fibres

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
 (1-6)-alpha-glucomannan
Cathartics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013