Flax Mucilage and Apparent Nutrient Digestibility

Obesity Clinical Trial

— HØRFRØ  

Official title:

Effect of Flaxseed and Flaxseed Mucilage on Energy Digestibility, Lipid Profile and Appetite

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00953004
• Other study ID #: B245
• Status: Active, not recruiting
• Phase: N/A
• First received: July 17, 2009
• Last updated: November 10, 2010
• Start date: March 2009
• Est. completion date: December 2009

Study information

• Verified date: August 2009
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

The aim is to study the effects of flaxseed mucilage, rich in dietary fiber on apparent fat and energy digestibility in young adults.

Description:

A 3 times 1-wk randomised crossover dietary intervention study, where the full diet is provided to 17 young subjects along with different flaxseed mucilage preparations. During the last five days, fecal samples are collected. Fasting blood samples are collected on day 1 and 8 in each period and appetite sensation is registered three times daily before the main meals.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 16
• Est. completion date: December 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• 18-40y

• BMI 22-28

• healthy

Exclusion Criteria:

• smoking

• medication

• excess PA

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

Dietary Supplement:
• fiber drink and fiber bread
fiber drink or fiber bread three times daily

Locations

Country	Name	City	State
Denmark	University of Copenhagen, Department og 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	Fat and energy digestibility		mean over period	No
Secondary	appetite		three times daily	No
Secondary	gastrointestinal distress		continously	Yes
Secondary	lipid profile		end of each period	No
Secondary	glucose and insulin		end of each period	No
Secondary	fecal output and transit time		mean of each period	No