Effect of Flaxseed on Lipid Uptake and Appetite

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00465036
• Other study ID #: KF 01 309595
• Secondary ID: B226
• Status: Completed
• Phase: N/A
• First received: April 23, 2007
• Last updated: March 25, 2009
• Start date: October 2006
• Est. completion date: October 2007

Study information

• Verified date: March 2009
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: October 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity

Intervention

Dietary Supplement:
• Whole flaxseeds, flaxseed mucilage, glucomannan

Locations

Country	Name	City	State
Denmark	Institute of Human Nutrition	Frederiksberg C

Sponsors (1)

Lead Sponsor	Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TAG in chylomicrons
Primary	serum TAG
Primary	HDL, LDL and total cholesterol
Primary	appetite scores
Primary	ad libium food intake
Primary	appetite hormone levels
Secondary	free fatty acid profile
Secondary	plasma glucose
Secondary	plasma insulin
Secondary	meal macronutrient composition
Secondary	meal energy content
Secondary	meal pleasantness