NCT01846117

Brief Summary

The investigators are investigating whether the flax lignan, secoisolariciresinol diglucoside, decreases oxidative stress and inflammation. The flax seed lignan is believed to be broken down in the body to produce the health benefits of flax. Flax lignan is separated from the whole flax seed as this compound is believed to have health effects. Decreasing oxidative stress and inflammation should improve a number of the problems associated with aging. This intervention consists of 600 milligrams of the flax lignan SDG daily or an equivalent amount of whey protein. The investigators are comparing lignan to a placebo (whey powder) to examine whether a dietary intervention (i.e. flax seed containing lignan) might decrease oxidative stress and inflammation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2013

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

April 1, 2013

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

April 30, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 3, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

June 14, 2018

Status Verified

June 1, 2018

Enrollment Period

1.6 years

First QC Date

April 30, 2013

Last Update Submit

June 12, 2018

Conditions

Oxidative StressInflammationAgingPain

Keywords

lignansoxidative stressinflammationagingmuscle weaknesspain

Outcome Measures

Primary Outcomes (1)

  • Safety of consumption of 600 mg/day of the flax lignan secoisolariciresinol diglucoside (SDG) in older adults (60-80 y)

    Adverse event occurrences will be compared descriptively between the SDG and placebo groups. Safety will be assessed at 0, 8, 16 and 24 weeks; as part of the blood collection (urea, creatinine, total bilirubin, platelets, hematocrit, haemoglobin, mean corpuscular haemoglobin, mean corpuscular volume, white blood cell count, total protein including albumin and prealbumin, total calcium, electrolytes, glucose, liver enzymes (Aspartate transaminase (AST), Alanine Aminotransferase (ALT), Alkaline phosphatase (ALP), total protein, albumin, lipids, HbA1c (for diabetic participants). Blood pressure, pulse and respiratory rate will also be monitored at these time points.

    24 weeks

Secondary Outcomes (5)

  • Effect of SDG on blood lipids

    24 weeks

  • Effect of SDG on inflammation

    24 weeks

  • Effect of SDG on quality of life

    24 weeks

  • Effect of SDG supplement on blood levels of flax lignan metabolites

    24 weeks

  • Effect of SDG supplement on fecal levels of flax lignan metabolites

    24 weeks

Study Arms (2)

secoisolariciresinol diglucoside

ACTIVE COMPARATOR

Secoisolariciresinol diglucoside (SDG) supplementation as 1.6g/day of BeneFlax containing 600 mg SDG. 1000 IU vitamin D as standard of care.

Dietary Supplement: secoisolariciresinol diglucoside, vitamin D

Whey powder

PLACEBO COMPARATOR

Natural Factors Whey Factors whey protein (unflavored). An equal volume of measured whey protein (unflavored) to the Beneflax and 1000 IU vitamin D as standard of care.

Dietary Supplement: secoisolariciresinol diglucoside, vitamin D

Interventions

secoisolariciresinol diglucoside, vitamin DDIETARY_SUPPLEMENT

SDG supplementation as a packet of 1.6g/day of BeneFlax containing 600 mg SDG for 24 weeks Vitamin D Natural Product Number (NPN) 80003663 WN Pharmaceuticals Natural Factors Whey Factors

Also known as: BeneFlax Flax Lignan Extract Archer Daniels Midland,#080001.
Whey powdersecoisolariciresinol diglucoside

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female adult 60 to 80 years residing in Saskatoon.
  • Able to comply with study protocol.
  • Able to follow simple instructions.

You may not qualify if:

  • Age below 60 or above 80 years at initiation of the study.
  • Individuals living in long term care homes.
  • Individuals at risk of hypotension or with symptomatic hypotension.
  • Fasting hypoglycemia.
  • Unstable diabetes, or diabetics taking insulin (note: eligible diabetic participants will undergo additional testing during the study).
  • Current cancer or diagnosed with cancer in the past 2 years.
  • Women with an immediate family history or personal history of breast cancer or ovarian cancer.
  • Significant liver or other gastrointestinal disorder including inflammatory bowel disease. (While constipation is the most common gastrointestinal problem in the elderly, it would not be a contraindication)
  • Significant kidney disorder.
  • Unstable or severe cardiac disease, recent myocardial infarction or stroke (either in past 6 months or significantly affecting physical mobility).
  • Unstable other medical disease including, but not limited to, pulmonary disorder, epilepsy and genitourinary disorder.
  • Migraine with aura within the last year (as this is a risk factor for stroke).
  • Current diagnosis of a bleeding condition, or at risk of bleeding.
  • Significant immunocompromise.
  • Other unstable conditions.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saskatoon Centre for Patient-Oriented Research

Saskatoon, Saskatchewan, S7K 0M7, Canada

Location

Related Publications (1)

  • Alcorn J, Whiting S, Viveky N, Di Y, Mansell K, Fowler S, Thorpe L, Almousa A, Cheng PC, Jones J, Billinsky J, Hadjistavropoulos T. Protocol for a 24-Week Randomized Controlled Study of Once-Daily Oral Dose of Flax Lignan to Healthy Older Adults. JMIR Res Protoc. 2017 Feb 3;6(2):e14. doi: 10.2196/resprot.6817.

    PMID: 28159728DERIVED

MeSH Terms

Conditions

InflammationPainMuscle Weakness

Interventions

secoisolariciresinol diglucosideVitamin D

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and SymptomsMuscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Jennifer Jones, MD, FRCPC

    University of Saskatchewan

    PRINCIPAL INVESTIGATOR

  • Jane Alcorn, DVD, PhD

    University of Saskatchewan

    STUDY CHAIR

  • Susan Whiting, PhD

    University of Saskatchewan

    STUDY CHAIR

  • Kerry Mansell, BSP, PharmD

    University of Saskatchewan

    STUDY CHAIR

  • Sharyle Fowler, MD

    University of Saskatchewan

    STUDY CHAIR

  • Lilian Thorpe, MD, PhD

    University of Saskatchewan

    STUDY CHAIR

  • Thomas Hadjistavropoulos, PhD, RD

    University of Regina

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2013

First Posted

May 3, 2013

Study Start

April 1, 2013

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

June 14, 2018

Record last verified: 2018-06

Locations

CA(1)