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

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

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

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.




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.



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01846117


Locations
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Canada, Saskatchewan
Saskatoon Centre for Patient-Oriented Research
Saskatoon, Saskatchewan, Canada, S7K 0M7
Sponsors and Collaborators
University of Saskatchewan
Saskatchewan Health Research Foundation
Investigators
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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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Saskatchewan
ClinicalTrials.gov Identifier: NCT01846117     History of Changes
Other Study ID Numbers: NHPD 186153
First Posted: May 3, 2013    Key Record Dates
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:
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Inflammation
Pathologic Processes
Vitamins
Vitamin D
Ergocalciferols
Secoisolariciresinol
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents
Phytoestrogens
Estrogens, Non-Steroidal
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists