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

University of Saskatchewan

Status and phase: Completed; Phase 2; Phase 1

Conditions: Aging; Inflammation; Oxidative Stress; Pain

Treatments: Dietary Supplement: secoisolariciresinol diglucoside, vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT01846117

NHPD 186153

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 60 to 80 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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32 participants in 2 patient groups, including a placebo group

secoisolariciresinol diglucoside

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: secoisolariciresinol diglucoside, vitamin D

Whey powder

Placebo Comparator group

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.

Treatment:

Dietary Supplement: secoisolariciresinol diglucoside, vitamin D