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Lignan

Flax Lignans and Heart Health (ISULignan Trial)

N/A
Waitlist Available
Led By Suzanne Hendrich, PhD
Research Sponsored by Iowa State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Men, 40-65 yrs/old, postmenopausal women 50-65 yrs/old not \> 5 yrs post menopause. All subjects were hypercholesterolemic with either total cholesterol \>240 mg/dl and \< 320 mg/dL or LDL cholesterol \>140 mg/dl and \<190 mg/dl at the screening visit.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks

Summary

Purpose: To demonstrate the efficacy of Beneflax™ flaxseed lignan (SDG) concentrate to lower serum cholesterol levels. Background: Flaxseed has been studied for various health benefits in humans, including prostate health, glucose control, and cardiovascular health. Cholesterol levels and high blood pressure are known to be risk factors for cardiovascular disease. Whole flaxseed has had variable effects on serum lipid levels, perhaps a consequence of variations in the amounts of secoisolariciresinol diglucoside (SDG) found in different flax cultivars, making the study of this bioactive compound difficult. Hypothesis: Flaxseed lignan (SDG) extract (Beneflax) significantly lowers total and LDL cholesterol. Flaxseed lignans also lower blood pressure and fasting glucose levels.

Eligible Conditions
  • High Cholesterol

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Changes in serum clinical chemistry from baseline to end of treatment

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: 300 mg/day BeneflaxExperimental Treatment1 Intervention
2 pills taken at breakfast and dinner containing a total of 300 mg secoisolariciresinol (SDG) per day for 12 weeks
Group II: 150 mg/day BeneflaxExperimental Treatment1 Intervention
2 pills taken at breakfast and dinner containing a total of 150 mg secoisolariciresinol (SDG) per day for 12 weeks
Group III: placeboPlacebo Group1 Intervention
placebo pill, diet counseling to comply with NCEP Step I diet
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
secoisolariciresinol diglucoside-containing extract of flaxseed
2007
N/A
~100

Find a Location

Who is running the clinical trial?

Iowa State UniversityLead Sponsor
61 Previous Clinical Trials
144,721 Total Patients Enrolled
Archer Daniels Midland Co.Industry Sponsor
1 Previous Clinical Trials
20 Total Patients Enrolled
Suzanne Hendrich, PhDPrincipal InvestigatorIowa State University
1 Previous Clinical Trials
20 Total Patients Enrolled
~5 spots leftby Jan 2026
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