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

Sponsor

University of Saskatchewan (Other)

Overall Status

Completed

CT.gov ID

NCT01846117

Collaborator

Saskatchewan Health Research Foundation (Other)

Enrollment

Location

Arms

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

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

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 :

Apr 1, 2013

Actual Primary Completion Date :

Nov 1, 2014

Actual Study Completion Date :

Nov 1, 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 Names: 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 Names: BeneFlax Flax Lignan Extract Archer Daniels Midland,#080001.

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 Names:

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 Names:

BeneFlax Flax Lignan Extract Archer Daniels Midland,#080001.

Outcome Measures

Primary Outcome Measures

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

Effect of SDG on blood lipids [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.
Effect of SDG on inflammation [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).
Effect of SDG on quality of life [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.
Effect of SDG supplement on blood levels of flax lignan metabolites [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.
Effect of SDG supplement on fecal levels of flax lignan metabolites [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

Criteria

Ages Eligible for Study:

60 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.