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
  Purpose

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.


Condition Intervention
Hypercholesterolemia
Dietary Supplement: secoisolariciresinol diglucoside-containing extract of flaxseed

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Iowa State Study on Flax Lignans and Heart Health

Resource links provided by NLM:


Further study details as provided by Iowa State University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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


Enrollment: 93
Study Start Date: December 2007
Study Completion Date: November 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo
placebo pill, diet counseling to comply with NCEP Step I diet
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
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
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
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
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

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01314586

Locations
United States, Iowa
Nutrition & Wellness Research Center
Ames, Iowa, United States, 50011
Sponsors and Collaborators
Iowa State University
Archer Daniels Midland Co.
Investigators
Principal Investigator: Suzanne Hendrich, PhD Iowa State University
  More Information

No publications provided

Responsible Party: Suzanne Hendrich, PhD, University Professor, Iowa State University
ClinicalTrials.gov Identifier: NCT01314586     History of Changes
Other Study ID Numbers: ADM Beneflax ISU-1
Study First Received: March 9, 2011
Last Updated: March 11, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Iowa State University:
hypercholesterolemia
postmenopause
secoisolariciresinol diglucoside
flaxseed
lignans
enterolactone
enterodiol
serum cholesterol
LDL cholesterol

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Secoisolariciresinol
Phytoestrogens
Estrogens, Non-Steroidal
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014