NCT00465036

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Oct 2006

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 24, 2007

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

March 26, 2009

Status Verified

March 1, 2009

First QC Date

April 23, 2007

Last Update Submit

March 25, 2009

Conditions

Obesity

Keywords

fat absorptionfibres

Outcome Measures

Primary Outcomes (6)

  • TAG in chylomicrons

  • serum TAG

  • HDL, LDL and total cholesterol

  • appetite scores

  • ad libium food intake

  • appetite hormone levels

Secondary Outcomes (6)

  • free fatty acid profile

  • plasma glucose

  • plasma insulin

  • meal macronutrient composition

  • meal energy content

  • +1 more secondary outcomes

Interventions

Whole flaxseeds, flaxseed mucilage, glucomannanDIETARY_SUPPLEMENT

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy males aged 18-40 years
  • Normal weight or moderately overweigh (BMI 25-30 kg/m2)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Human Nutrition

Frederiksberg C, 1958, Denmark

Location

MeSH Terms

Conditions

Obesity

Interventions

(1-6)-alpha-glucomannan

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Søren Toubro, MD

    Institute of Human Nutrition

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 23, 2007

First Posted

April 24, 2007

Study Start

October 1, 2006

Study Completion

October 1, 2007

Last Updated

March 26, 2009

Record last verified: 2009-03

Locations

DK(1)