Once-Daily Oral Dose of BeneFlax to Healthy Older Adults (MOD)

• ClinicalTrials.gov Identifier: NCT01846117
• Recruitment Status: Completed
• First Posted: May 3, 2013
• Last Update Posted: June 14, 2018
• Sponsor: University of Saskatchewan
• Collaborator: Saskatchewan Health Research Foundation
• Information provided by (Responsible Party): University of Saskatchewan

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Oxidative Stress; Inflammation; Aging; Pain	Dietary Supplement: secoisolariciresinol diglucoside, vitamin D	Phase 1; Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Once-Daily Oral Dose of BeneFlax to Healthy Older Adults
• Study Start Date: April 2013
• Actual Primary Completion Date: November 2014
• Actual Study Completion Date: November 2014

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: secoisolariciresinol diglucoside; 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; 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; Other Name: BeneFlax Flax Lignan Extract Archer Daniels Midland,#080001.
Placebo Comparator: 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.	Dietary Supplement: 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; Other Name: BeneFlax Flax Lignan Extract Archer Daniels Midland,#080001.

Outcome Measures

Primary Outcome Measures :

1. Safety of consumption of 600 mg/day of the flax lignan secoisolariciresinol diglucoside (SDG) in older adults (60-80 y) [ Time Frame: 24 weeks ]
   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.

Secondary Outcome Measures :

1. Effect of SDG on blood lipids [ Time Frame: 24 weeks ]
   SDG and placebo groups will be compared at 0, 8, 16 and 24 weeks for changes in nonfasting levels of cholesterol, LDL, HDL, and triglycerides.
2. Effect of SDG on inflammation [ Time Frame: 24 weeks ]
   SDG and placebo groups will be compared at 0, 8, 16 and 24 weeks for changes in pro-inflammatory markers (Interleukin-6 (IL-6), IL-1α, IL-1β, 8-isoprostane, Tumor necrosis factor-α (TNF-α), C-reactive protein).
3. Effect of SDG on quality of life [ Time Frame: 24 weeks ]
   SDG and placebo groups will be compared at 0, 8, 16 and 24 weeks for changes in cognitive function, pain, and physical function.
4. Effect of SDG supplement on blood levels of flax lignan metabolites [ Time Frame: 24 weeks ]
   SDG and placebo groups will be compared at 0, 8, 16 and 24 weeks for changes in cognitive function, pain, and physical function.
5. Effect of SDG supplement on fecal levels of flax lignan metabolites [ Time Frame: 24 weeks ]
   To further understand the pharmacology of SDG, we will analyze fecal levels of the flax cyclolinopeptides. Levels will be determined 0 and 24 weeks.

Eligibility Criteria

• Ages Eligible for Study: 60 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

Canada, Saskatchewan

Saskatoon Centre for Patient-Oriented Research

Saskatoon, Saskatchewan, Canada, S7K 0M7

Sponsors and Collaborators

University of Saskatchewan

Saskatchewan Health Research Foundation

Investigators

• Principal Investigator: Jennifer Jones, MD, FRCPC; University of Saskatchewan
• Study Chair: 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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: University of Saskatchewan
• ClinicalTrials.gov Identifier: NCT01846117
• Other Study ID Numbers: NHPD 186153
• First Posted: May 3, 2013
• Last Update Posted: June 14, 2018
• Last Verified: June 2018

Keywords provided by University of Saskatchewan:

lignans; oxidative stress; inflammation; aging; muscle weakness; pain

Additional relevant MeSH terms:

Inflammation; Pathologic Processes; Vitamin D; Secoisolariciresinol; Vitamins; Micronutrients; Physiological Effects of Drugs; Bone Density Conservation Agents; Phytoestrogens; Estrogens, Non-Steroidal; Estrogens; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists