Oxidative Stress and Nutritional Supplementation Intervention Study

NCT01234506 | Completed Phase 2

• 1 other identifier: NHPD-150212
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

A major means whereby oxidative stress promotes aging-related disease is by activating inflammatory pathways. Decreasing oxidative stress and inflammation should ameliorate many of the problems associated with aging, including vascular dementia, Alzheimer's disease, osteoporosis, muscle wasting, insulin resistance, type 2 diabetes, and metabolic syndrome. Animal and human studies have demonstrated that consumption of vitamin D and phase 2 protein inducers decrease oxidative stress and associated inflammation. The flax lignan secoisolariciresinol diglucoside (SDG) is metabolized to enterolactone, a potent phase 2 protein inducer. Animal and human studies have shown that consumption of flax seed or its component SDG decreases hypertension, serum cholesterol, atherosclerosis, the growth of experimentally-induced cancers as well as metastases of human breast tumours implanted into nude mice, and delays the development of type 2 diabetes. Vitamin D plays a role in modulating inflammation, enhancing immunity (while suppressing autoimmune injury) and exerting control over cell differentiation. Adequate levels of vitamin D also appear to promote better glycemic control. The investigators predict that consumption of SDG in persons with adequate vitamin D status will decrease oxidative stress and associated inflammation. If this hypothesis is upheld, this research has the potential to greatly decrease healthcare costs while allowing healthier aging.

Conditions

Oxidative Stress; Inflammation; Aging; Dementia; Pain

Keywords

long term care; lignans; oxidative stress; inflammation; aging; dementia; postural balance; depression; muscle weakness; quality of life; pain

Outcome Measures

Primary Outcomes (2)

• Safety of consumption of 300 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, 6, 12, 18 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 (AST, ALT, ALP), total protein, albumin, lipids, HbA1c (for diabetic participants). Blood pressure measurements will be performed every two weeks

  24 weeks

• Effect of SDG on oxidative stress and inflammation

  SDG and placebo groups will be compared at 0, 12 and 24 weeks for changes in oxidative stress measurements (plasma malondialdehyde), pro-inflammatory markers (IL-6, IL-1α, IL-1β, 8-isoprostane, TNF-α, C-reactive protein).

  24 weeks

Secondary Outcomes (4)

• Effect of SDG on quality of life

  24 weeks

• Effect of SDG supplement on blood levels of flax lignan metabolites

  24 weeks

• To measure effects of SDG on bone resorption

  24 weeks

• Effect of SDG on blood lipids

  24 weeks

Study Arms (2)

secoisolariciresinol diglucoside

ACTIVE COMPARATOR

Secoisolariciresinol diglucoside (SDG) supplementation as 0.8g/day of BeneFlax containing 300 mg SDG. 1000 IU vitamin D as standard of care.

Dietary Supplement: secoisolariciresinol diglucoside

Placebo

PLACEBO COMPARATOR

An equal volume of measured whey protein (unflavored) to the Beneflax and 1000 IU vitamin D as standard of care.

Dietary Supplement: secoisolariciresinol diglucoside

Interventions

secoisolariciresinol diglucoside DIETARY_SUPPLEMENT

SDG supplementation as a packet of 0.8g/day of BeneFlax containing 300 mg SDG for 24 weeks

Also known as: Beneflax Flax Lignan Extract Archer Daniels Midland,#080001., Natural Factors Whey Factors whey protein (unflavored)., Vitamin D NPN 80003663 WN Pharmaceuticals

Placebo; secoisolariciresinol diglucoside

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults residing in a long term care facility
• resident for a minimum of four weeks prior to entry
• able to comply with study protocol
• able to follow simple instructions
• able to give informed consent or has a legally acceptable representative who is able to provide consent

You may not qualify if:

• Age below 60 or above 80 years.
• Individuals at risk of hypotension or with symptomatic hypotension.
• Fasting hypoglycemia.
• Unstable diabetes
• Diabetics taking insulin
• 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 disorder
• Significant gastrointestinal disorder including inflammatory bowel disease but not constipation
• Significant kidney disorder
• Unstable or severe cardiac disease, recent MI or stroke either in past 6 months or significantly (i.e., severely) 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.

Sponsors & Collaborators

• University of Saskatchewan: lead
• Saskatchewan Health Research Foundation: collaborator

Study Sites (1)

Saskatoon Health Region

Saskatoon, Saskatchewan, S7K 5T6, Canada

Location

Related Publications (3)

• Adolphe JL, Whiting SJ, Juurlink BH, Thorpe LU, Alcorn J. Health effects with consumption of the flax lignan secoisolariciresinol diglucoside. Br J Nutr. 2010 Apr;103(7):929-38. doi: 10.1017/S0007114509992753. Epub 2009 Dec 15.

  PMID: 20003621 BACKGROUND

• Di Y, Jones J, Mansell K, Whiting S, Fowler S, Thorpe L, Billinsky J, Viveky N, Cheng PC, Almousa A, Hadjistavropoulos T, Alcorn J. Influence of Flaxseed Lignan Supplementation to Older Adults on Biochemical and Functional Outcome Measures of Inflammation. J Am Coll Nutr. 2017 Nov-Dec;36(8):646-653. doi: 10.1080/07315724.2017.1342213. Epub 2017 Sep 18.

  PMID: 28922068 RESULT

• 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.

  PMID: 28159728 RESULT

MeSH Terms

Conditions

Inflammation; Dementia; Pain; Depression; Muscle Weakness

Interventions

secoisolariciresinol diglucoside

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Behavioral Symptoms; Behavior; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations

Study Officials

• Susan J Whiting, PhD

  University of Saskatchewan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: November 2, 2010
• First Posted: November 4, 2010
• Study Start: October 1, 2010
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: October 25, 2018

Record last verified: 2018-10

Locations

CA (1)