Once-Daily Oral Dose of BeneFlax to Healthy Older Adults

NCT ID: NCT01846117

Last Updated: 2018-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2014-11-30

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.

Conditions

Oxidative Stress; Inflammation; Aging; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

secoisolariciresinol diglucoside

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

Group Type: ACTIVE_COMPARATOR

secoisolariciresinol diglucoside, vitamin D

Intervention Type: DIETARY_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

Whey powder

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.

Group Type: PLACEBO_COMPARATOR

secoisolariciresinol diglucoside, vitamin D

Intervention Type: DIETARY_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

Interventions

secoisolariciresinol diglucoside, vitamin D

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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

BeneFlax Flax Lignan Extract Archer Daniels Midland,#080001.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.
• Current use of hormone replacement therapy (except thyroid medication is allowed).
• Current use of warfarin, clopidogrel, ticlopidine, dipyridamole or their analogues.
• Intolerances or allergies to flax or vitamin D.
• Allergy to whey
• Surgery within the last six months.
• Participation in any other clinical trial with an investigational agent within one month prior to randomization.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Saskatchewan Health Research Foundation

OTHER

Sponsor Role: collaborator

University of Saskatchewan

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer Jones, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

University of Saskatchewan

Jane Alcorn, DVD, PhD

Role: STUDY_CHAIR

University of Saskatchewan

Susan Whiting, PhD

Role: STUDY_CHAIR

University of Saskatchewan

Kerry Mansell, BSP, PharmD

Role: STUDY_CHAIR

University of Saskatchewan

Sharyle Fowler, MD

Role: STUDY_CHAIR

University of Saskatchewan

Lilian Thorpe, MD, PhD

Role: STUDY_CHAIR

University of Saskatchewan

Thomas Hadjistavropoulos, PhD, RD

Role: STUDY_CHAIR

University of Regina

Locations

Saskatoon Centre for Patient-Oriented Research

Saskatoon, Saskatchewan, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 28159728 (View on PubMed)

Other Identifiers

NHPD 186153

Identifier Type: -

Identifier Source: org_study_id