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Flax Lignans and Heart Health (ISULignan)

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
secoisolariciresinol diglucoside-containing extract of flaxseed
Sponsored by
Iowa State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypercholesterolemia focused on measuring hypercholesterolemia, postmenopause, secoisolariciresinol diglucoside, flaxseed, lignans, enterolactone, enterodiol, serum cholesterol, LDL cholesterol

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nutrition & Wellness Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

placebo

150 mg/day Beneflax

300 mg/day Beneflax

Arm Description

placebo pill, diet counseling to comply with NCEP Step I diet

2 pills taken at breakfast and dinner containing a total of 150 mg secoisolariciresinol (SDG) per day for 12 weeks

2 pills taken at breakfast and dinner containing a total of 300 mg secoisolariciresinol (SDG) per day for 12 weeks

Outcomes

Primary Outcome Measures

Change in serum total cholesterol from baseline to 12 weeks after intervention treatments
Change in serum glucose from baseline to 12 weeks after intervention treatments
Change in blood pressure from baseline to end of treatment

Secondary Outcome Measures

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

Full Information

First Posted
March 9, 2011
Last Updated
March 11, 2011
Sponsor
Iowa State University
Collaborators
Archer Daniels Midland Co.
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1. Study Identification

Unique Protocol Identification Number
NCT01314586
Brief Title
Flax Lignans and Heart Health
Acronym
ISULignan
Official Title
Iowa State Study on Flax Lignans and Heart Health
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Iowa State University
Collaborators
Archer Daniels Midland Co.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
Keywords
hypercholesterolemia, postmenopause, secoisolariciresinol diglucoside, flaxseed, lignans, enterolactone, enterodiol, serum cholesterol, LDL cholesterol

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
93 (Actual)

8. Arms, Groups, and Interventions

Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo pill, diet counseling to comply with NCEP Step I diet
Arm Title
150 mg/day Beneflax
Arm Type
Experimental
Arm Description
2 pills taken at breakfast and dinner containing a total of 150 mg secoisolariciresinol (SDG) per day for 12 weeks
Arm Title
300 mg/day Beneflax
Arm Type
Experimental
Arm Description
2 pills taken at breakfast and dinner containing a total of 300 mg secoisolariciresinol (SDG) per day for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
secoisolariciresinol diglucoside-containing extract of flaxseed
Other Intervention Name(s)
Beneflax
Intervention Description
0, 150 or 300 mg/day as 2 pills taken at breakfast and dinner, dietary counseling to comply with NCEP Step I diet
Primary Outcome Measure Information:
Title
Change in serum total cholesterol from baseline to 12 weeks after intervention treatments
Time Frame
12 weeks
Title
Change in serum glucose from baseline to 12 weeks after intervention treatments
Time Frame
12 weeks
Title
Change in blood pressure from baseline to end of treatment
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Changes in serum clinical chemistry from baseline to end of treatment
Description
serum uric acid, BUN, Na, K, Cl, Ca, P, LDH, AST, ALT, bilirubin, carbon dioxide
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanne Hendrich, PhD
Organizational Affiliation
Iowa State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nutrition & Wellness Research Center
City
Ames
State/Province
Iowa
ZIP/Postal Code
50011
Country
United States

12. IPD Sharing Statement

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Flax Lignans and Heart Health

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