Flax Lignans and Heart Health (ISULignan)

This study has been completed.
Sponsor:
Collaborator:
Archer Daniels Midland Co.
Information provided by:
Iowa State University
ClinicalTrials.gov Identifier:
NCT01314586
First received: March 9, 2011
Last updated: March 11, 2011
Last verified: March 2011

March 9, 2011
March 11, 2011
December 2007
July 2009   (final data collection date for primary outcome measure)
  • Change in serum total cholesterol from baseline to 12 weeks after intervention treatments [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in serum glucose from baseline to 12 weeks after intervention treatments [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in blood pressure from baseline to end of treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01314586 on ClinicalTrials.gov Archive Site
Changes in serum clinical chemistry from baseline to end of treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
serum uric acid, BUN, Na, K, Cl, Ca, P, LDH, AST, ALT, bilirubin, carbon dioxide
Same as current
Not Provided
Not Provided
 
Flax Lignans and Heart Health
Iowa State Study on Flax Lignans and Heart Health

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Hypercholesterolemia
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
Other Name: Beneflax
  • Placebo Comparator: placebo
    placebo pill, diet counseling to comply with NCEP Step I diet
    Intervention: Dietary Supplement: secoisolariciresinol diglucoside-containing extract of flaxseed
  • Experimental: 150 mg/day Beneflax
    2 pills taken at breakfast and dinner containing a total of 150 mg secoisolariciresinol (SDG) per day for 12 weeks
    Intervention: Dietary Supplement: secoisolariciresinol diglucoside-containing extract of flaxseed
  • Experimental: 300 mg/day Beneflax
    2 pills taken at breakfast and dinner containing a total of 300 mg secoisolariciresinol (SDG) per day for 12 weeks
    Intervention: Dietary Supplement: secoisolariciresinol diglucoside-containing extract of flaxseed
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
93
November 2009
July 2009   (final data collection date for primary outcome measure)

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.
Both
40 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01314586
ADM Beneflax ISU-1
No
Suzanne Hendrich, PhD, University Professor, Iowa State University
Iowa State University
Archer Daniels Midland Co.
Principal Investigator: Suzanne Hendrich, PhD Iowa State University
Iowa State University
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP