NCT00204412

Brief Summary

The purpose of our study is to use a flaxseed-based nutritional supplement in combination with exercise training (walking) for improving cholesterol levels. We hypothesize that exercise training will improve cholesterol profile and that adding supplementation with a flaxseed nutritional supplement will further improve cholesterol profile.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2005

Shorter than P25 for phase_3

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

November 5, 2007

Status Verified

November 1, 2007

First QC Date

September 12, 2005

Last Update Submit

November 1, 2007

Conditions

Metabolic SyndromeOsteoporosis

Keywords

CholesterolHigh density lipoproteinLow density lipoproteinTriglycerideGlucoseExerciseFitnessFlaxLignanPhytoestrogenbone

Outcome Measures

Primary Outcomes (1)

  • metabolic syndrome score

    6 months

Secondary Outcomes (14)

  • Total cholesterol at 2, 4, and 6 months

    6 months

  • High density lipoprotein at 2, 4, and 6 months

    6 months

  • Low density lipoprotein at 2, 4, and 6 months

    6 months

  • Triglycerides at 2, 4, and 6 months

    6 months

  • Blood glucose at 2, 4, and 6 months

    6 months

  • +9 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

flax lignan

Dietary Supplement: Flax lignanBehavioral: Exercise (walking)

2

PLACEBO COMPARATOR

placebo

Dietary Supplement: Flax lignan

Interventions

Flax lignanDIETARY_SUPPLEMENT

543 mg SDG per day

Also known as: Archer Daniels Midland
12
Exercise (walking)BEHAVIORAL

walking 45 minutes per day 5 days per week

1

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older

You may not qualify if:

  • Currently taking medication for cholesterol
  • Smoker
  • Diabetic
  • Gastrointestinal disease
  • Females on hormone replacement therapy
  • Currently taking a flaxseed supplement
  • Currently engaged in vigorous exercise training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Saskatchewan

Saskatoon, Saskatchewan, S7N 5B2, Canada

Location

MeSH Terms

Conditions

Metabolic SyndromeOsteoporosisMotor Activity

Interventions

ExerciseWalking

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaLocomotion

Study Officials

  • Philip D Chilibeck, PhD

    University of Saskatchewan

    PRINCIPAL INVESTIGATOR

  • H J Biem, MD

    University of Saskatchewan

    STUDY DIRECTOR

  • Lisa Paus-Jenssen, MD

    University of Saskatchewan

    STUDY DIRECTOR

  • Susan Whiting, PhD

    University of Saskatchewan

    STUDY DIRECTOR

  • Punam Pahwa, PhD

    University of Saskatchewan

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

March 1, 2005

Study Completion

March 1, 2006

Last Updated

November 5, 2007

Record last verified: 2007-11

Locations

CA(1)