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

Primary Purpose

Oxidative Stress, Inflammation, Aging

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
secoisolariciresinol diglucoside, vitamin D
Sponsored by
University of Saskatchewan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Oxidative Stress focused on measuring lignans, oxidative stress, inflammation, aging, muscle weakness, pain

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Saskatoon Centre for Patient-Oriented Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

secoisolariciresinol diglucoside

Whey powder

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Effect of SDG on blood lipids
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.
Effect of SDG on inflammation
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).
Effect of SDG on quality of life
SDG and placebo groups will be compared at 0, 8, 16 and 24 weeks for changes in cognitive function, pain, and physical function.
Effect of SDG supplement on blood levels of flax lignan metabolites
SDG and placebo groups will be compared at 0, 8, 16 and 24 weeks for changes in cognitive function, pain, and physical function.
Effect of SDG supplement on fecal levels of flax lignan metabolites
To further understand the pharmacology of SDG, we will analyze fecal levels of the flax cyclolinopeptides. Levels will be determined 0 and 24 weeks.

Full Information

First Posted
April 30, 2013
Last Updated
June 12, 2018
Sponsor
University of Saskatchewan
Collaborators
Saskatchewan Health Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01846117
Brief Title
Once-Daily Oral Dose of BeneFlax to Healthy Older Adults
Acronym
MOD
Official Title
Once-Daily Oral Dose of BeneFlax to Healthy Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Saskatchewan
Collaborators
Saskatchewan Health Research Foundation

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oxidative Stress, Inflammation, Aging, Pain
Keywords
lignans, oxidative stress, inflammation, aging, muscle weakness, pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
secoisolariciresinol diglucoside
Arm Type
Active Comparator
Arm Description
Secoisolariciresinol diglucoside (SDG) supplementation as 1.6g/day of BeneFlax containing 600 mg SDG. 1000 IU vitamin D as standard of care.
Arm Title
Whey powder
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
secoisolariciresinol diglucoside, vitamin D
Other Intervention Name(s)
BeneFlax Flax Lignan Extract Archer Daniels Midland,#080001.
Intervention Description
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
Primary Outcome Measure Information:
Title
Safety of consumption of 600 mg/day of the flax lignan secoisolariciresinol diglucoside (SDG) in older adults (60-80 y)
Description
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.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Effect of SDG on blood lipids
Description
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.
Time Frame
24 weeks
Title
Effect of SDG on inflammation
Description
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).
Time Frame
24 weeks
Title
Effect of SDG on quality of life
Description
SDG and placebo groups will be compared at 0, 8, 16 and 24 weeks for changes in cognitive function, pain, and physical function.
Time Frame
24 weeks
Title
Effect of SDG supplement on blood levels of flax lignan metabolites
Description
SDG and placebo groups will be compared at 0, 8, 16 and 24 weeks for changes in cognitive function, pain, and physical function.
Time Frame
24 weeks
Title
Effect of SDG supplement on fecal levels of flax lignan metabolites
Description
To further understand the pharmacology of SDG, we will analyze fecal levels of the flax cyclolinopeptides. Levels will be determined 0 and 24 weeks.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Jones, MD, FRCPC
Organizational Affiliation
University of Saskatchewan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jane Alcorn, DVD, PhD
Organizational Affiliation
University of Saskatchewan
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Susan Whiting, PhD
Organizational Affiliation
University of Saskatchewan
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kerry Mansell, BSP, PharmD
Organizational Affiliation
University of Saskatchewan
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sharyle Fowler, MD
Organizational Affiliation
University of Saskatchewan
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Lilian Thorpe, MD, PhD
Organizational Affiliation
University of Saskatchewan
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Thomas Hadjistavropoulos, PhD, RD
Organizational Affiliation
University of Regina
Official's Role
Study Chair
Facility Information:
Facility Name
Saskatoon Centre for Patient-Oriented Research
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7K 0M7
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
28159728
Citation
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.
Results Reference
derived

Learn more about this trial

Once-Daily Oral Dose of BeneFlax to Healthy Older Adults

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