Effect of Flaxseed on Lipid Uptake and Appetite - Full Text View

Sponsored by:	University of Copenhagen
Information provided by:	University of Copenhagen
ClinicalTrials.gov Identifier:	NCT00465036

Purpose

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

Condition	Intervention
Obesity	Behavioral: Whole flaxseeds, flaxseed mucilage, glucomannan

MedlinePlus related topics: Obesity

Drug Information available for: Insulin Lipids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Active Control, Crossover Assignment, Efficacy Study
Official Title:	Effect of Whole Flaxseeds and Flaxseed Mucilage on Lipid Absorption, Glucoseand Insulin Metabolsim 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 pleasentness

Estimated Enrollment:	18
Study Start Date:	October 2006
Estimated Study Completion Date:	May 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 app. 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 tst 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

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

Keywords provided by University of Copenhagen:

fat absorption
fibres

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
(1-6)-alpha-glucomannan

Nutrition Disorders
Overweight
Overnutrition
Insulin

Additional relevant MeSH terms:

Therapeutic Uses
Gastrointestinal Agents
Cathartics
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009