Effect of Flaxseed on Lipid Uptake and Appetite

March 25, 2009 updated by: University of Copenhagen

Effect of Whole Flaxseeds and Flaxseed Mucilage on Lipid Absorption, Glucose and Insulin Metabolism and Appetite Regulation

Randomized trial to test the effect of flaxseed fractions on appetite regulation and intestinal lipid absorption.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

18

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
        • Institute of 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

Yes

Genders Eligible for Study

Male

Description

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)

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: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
TAG in chylomicrons
serum TAG
HDL, LDL and total cholesterol
appetite scores
ad libium food intake
appetite hormone levels

Secondary Outcome Measures

Outcome Measure
free fatty acid profile
plasma glucose
plasma insulin
meal macronutrient composition
meal energy content
meal pleasantness

Collaborators and Investigators

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

Sponsor

University of Copenhagen

Investigators

  • Principal Investigator: Søren Toubro, MD, Institute of Human Nutrition

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

October 1, 2006

Study Completion (ACTUAL)

October 1, 2007

Study Registration Dates

First Submitted

April 23, 2007

First Submitted That Met QC Criteria

April 23, 2007

First Posted (ESTIMATE)

April 24, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

March 26, 2009

Last Update Submitted That Met QC Criteria

March 25, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KF 01 309595
  • B226

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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