Flax Lignans and Heart Health

Hypercholesterolemia Clinical Trial

— ISULignan  

Official title:

Iowa State Study on Flax Lignans and Heart Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01314586
• Other study ID #: ADM Beneflax ISU-1
• Status: Completed
• Phase: N/A
• First received: March 9, 2011
• Last updated: March 11, 2011
• Start date: December 2007
• Est. completion date: November 2009

Study information

• Verified date: March 2011
• Source: Iowa State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: November 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Excluded subjects included diabetics, people being actively treated with niacins, fibrates, statins, insulin, ACE inhibitors or other cholesterol/ blood pressure pharmaceutical treatments, people who consumed large amounts of soy, flax, rye breads, pumpkin seeds, hydrolyzed milk products, sterols, and/or berries (strawberries/blueberries) or supplements aimed at cholesterol reduction such as spruce lignans, sytrinol (poly methoxylated flavanols), polycosinols, people consuming flaxseed on a regular basis.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Dietary Supplement:
• secoisolariciresinol diglucoside-containing extract of flaxseed
0, 150 or 300 mg/day as 2 pills taken at breakfast and dinner, dietary counseling to comply with NCEP Step I diet

Locations

Country	Name	City	State
United States	Nutrition & Wellness Research Center	Ames	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
Iowa State University	Archer Daniels Midland Co.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in serum total cholesterol from baseline to 12 weeks after intervention treatments		12 weeks	No
Primary	Change in serum glucose from baseline to 12 weeks after intervention treatments		12 weeks	No
Primary	Change in blood pressure from baseline to end of treatment		12 weeks	No
Secondary	Changes in serum clinical chemistry from baseline to end of treatment	serum uric acid, BUN, Na, K, Cl, Ca, P, LDH, AST, ALT, bilirubin, carbon dioxide	12 weeks	Yes