Flax Lignans and Heart Health (ISULignan)
This study has been completed.
Sponsor:
Iowa State University
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
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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
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 May 21, 2013