NCT01314586

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 9, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 14, 2011

Completed
Last Updated

March 14, 2011

Status Verified

March 1, 2011

Enrollment Period

1.6 years

First QC Date

March 9, 2011

Last Update Submit

March 11, 2011

Conditions

Hypercholesterolemia

Keywords

hypercholesterolemiapostmenopausesecoisolariciresinol diglucosideflaxseedlignansenterolactoneenterodiolserum cholesterolLDL cholesterol

Outcome Measures

Primary Outcomes (3)

  • Change in serum total cholesterol from baseline to 12 weeks after intervention treatments

    12 weeks

  • Change in serum glucose from baseline to 12 weeks after intervention treatments

    12 weeks

  • Change in blood pressure from baseline to end of treatment

    12 weeks

Secondary Outcomes (1)

  • Changes in serum clinical chemistry from baseline to end of treatment

    12 weeks

Study Arms (3)

placebo

PLACEBO COMPARATOR

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

Dietary Supplement: secoisolariciresinol diglucoside-containing extract of flaxseed

150 mg/day Beneflax

EXPERIMENTAL

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

300 mg/day Beneflax

EXPERIMENTAL

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

Interventions

secoisolariciresinol diglucoside-containing extract of flaxseedDIETARY_SUPPLEMENT

0, 150 or 300 mg/day as 2 pills taken at breakfast and dinner, dietary counseling to comply with NCEP Step I diet

Also known as: Beneflax
150 mg/day Beneflax300 mg/day Beneflaxplacebo

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nutrition & Wellness Research Center

Ames, Iowa, 50011, United States

Location

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Suzanne Hendrich, PhD

    Iowa State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 9, 2011

First Posted

March 14, 2011

Study Start

December 1, 2007

Primary Completion

July 1, 2009

Study Completion

November 1, 2009

Last Updated

March 14, 2011

Record last verified: 2011-03

Locations

US(1)