Effect of Flaxseed on Lipid Uptake and Appetite - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

April 23, 2007

Last Updated Date

March 25, 2009

Start Date ^†

October 2006

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

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

Change History

Complete list of historical versions of study NCT00465036 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

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

Original Secondary Outcome Measures ^†

free fatty acid profile
plasma glucose
plasma insulin
meal macronutrient composition
meal energy content
meal pleasentness

Descriptive Information

Brief Title ^†

Effect of Flaxseed on Lipid Uptake and Appetite

Official Title ^†

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

Brief Summary

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

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 Phase

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Double-Blind, Active Control, Crossover Assignment, Efficacy Study

Condition ^†

Obesity

Intervention ^†

Dietary Supplement: Whole flaxseeds, flaxseed mucilage, glucomannan

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

October 2007

Primary Completion Date

Eligibility 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)

Gender

Male

Ages

18 Years to 40 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

Denmark

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00465036

Responsible Party

Secondary IDs ^††

B226

Study Sponsor ^†

University of Copenhagen

Collaborators ^††

Investigators ^†

Principal Investigator:

Søren Toubro, MD

Institute of Human Nutrition

Information Provided By

University of Copenhagen

Verification Date

March 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.