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Protocol for a 24-Week Randomized Controlled Study of Once-Daily Oral Dose of Flax Lignan to Healthy Older Adults

BACKGROUND: Increased oxidative stress and inflammation are associated with aging, and contribute to an increased risk of chronic disease in older adults. Flaxseed lignans demonstrate antioxidant and anti-inflammatory activity, but their ability to reduce oxidative stress and inflammation markers in...

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Autores principales: Alcorn, Jane, Whiting, Susan, Viveky, Navita, Di, Yunyun, Mansell, Kerry, Fowler, Sharyle, Thorpe, Lilian, Almousa, Ahmed, Cheng, Pui Chi, Jones, Jennifer, Billinsky, Jennifer, Hadjistavropoulos, Thomas
Formato: Online Artículo Texto
Lenguaje:English
Publicado: JMIR Publications 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5315765/
https://www.ncbi.nlm.nih.gov/pubmed/28159728
http://dx.doi.org/10.2196/resprot.6817
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author Alcorn, Jane
Whiting, Susan
Viveky, Navita
Di, Yunyun
Mansell, Kerry
Fowler, Sharyle
Thorpe, Lilian
Almousa, Ahmed
Cheng, Pui Chi
Jones, Jennifer
Billinsky, Jennifer
Hadjistavropoulos, Thomas
author_facet Alcorn, Jane
Whiting, Susan
Viveky, Navita
Di, Yunyun
Mansell, Kerry
Fowler, Sharyle
Thorpe, Lilian
Almousa, Ahmed
Cheng, Pui Chi
Jones, Jennifer
Billinsky, Jennifer
Hadjistavropoulos, Thomas
author_sort Alcorn, Jane
collection PubMed
description BACKGROUND: Increased oxidative stress and inflammation are associated with aging, and contribute to an increased risk of chronic disease in older adults. Flaxseed lignans demonstrate antioxidant and anti-inflammatory activity, but their ability to reduce oxidative stress and inflammation markers in older adult populations has received limited investigation. OBJECTIVE: This is a chronic intervention trial of community-dwelling healthy older adults to examine the effects of a flaxseed lignan (secoisolariciresinol diglucoside; SDG) enriched supplement (BeneFlax) compared to a placebo. The primary aim was to demonstrate the safety of BeneFlax and confirm its anti-inflammatory efficacy on markers of oxidative stress and inflammation, and subsequent functional outcomes, including those associated with its anti-inflammatory efficacy. A secondary aim was to determine flaxseed lignan metabolite concentrations in blood. METHODS: A double-blind randomized clinical trial was conducted. Subjects were healthy community-dwelling adults aged 60-80 years. Testing was performed at baseline, 8, 16, and 24 weeks. The 24-week intervention consisted of 600 milligrams (mg) of SDG daily or an equivalent amount (volume) of placebo. All participants received 1000 international units of vitamin D to ensure adequate vitamin D status. Measurements consisted of blood pressure, hematology, and tolerability for safety assessments; blood oxidative stress and inflammatory biomarkers for efficacy; and cognition, muscle strength, and pain as functional outcomes. Secondary endpoints of plasma levels of lignan metabolites were analyzed by mass spectrometry. Other tests, such as bone turnover markers and fecal levels of flax cyclolinopeptides, will be performed at a later date. RESULTS: Thirty-two participants were recruited (19 intervention and 13 control) and all completed the trial. Numerous Health Canada-imposed exclusion criteria limited recruitment success. Analyses are ongoing, but the baseline data available for a number of parameters indicate no differences between treatment groups. Safety measures (vital signs) did not change from baseline and were not significantly different between treatment and placebo groups at 24 weeks. CONCLUSIONS: Preliminary results indicate that no safety concerns are associated with administering 600 mg SDG for 24 weeks to adults between the ages of 60 and 80 years. TRIAL REGISTRATION: Clinicaltrials.gov NCT01846117; https://clinicaltrials.gov/ct2/show/NCT01846117 (Archived by WebCite at http://www.webcitation.org/6nlDZNjmA)
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spelling pubmed-53157652017-02-27 Protocol for a 24-Week Randomized Controlled Study of Once-Daily Oral Dose of Flax Lignan to Healthy Older Adults Alcorn, Jane Whiting, Susan Viveky, Navita Di, Yunyun Mansell, Kerry Fowler, Sharyle Thorpe, Lilian Almousa, Ahmed Cheng, Pui Chi Jones, Jennifer Billinsky, Jennifer Hadjistavropoulos, Thomas JMIR Res Protoc Protocol BACKGROUND: Increased oxidative stress and inflammation are associated with aging, and contribute to an increased risk of chronic disease in older adults. Flaxseed lignans demonstrate antioxidant and anti-inflammatory activity, but their ability to reduce oxidative stress and inflammation markers in older adult populations has received limited investigation. OBJECTIVE: This is a chronic intervention trial of community-dwelling healthy older adults to examine the effects of a flaxseed lignan (secoisolariciresinol diglucoside; SDG) enriched supplement (BeneFlax) compared to a placebo. The primary aim was to demonstrate the safety of BeneFlax and confirm its anti-inflammatory efficacy on markers of oxidative stress and inflammation, and subsequent functional outcomes, including those associated with its anti-inflammatory efficacy. A secondary aim was to determine flaxseed lignan metabolite concentrations in blood. METHODS: A double-blind randomized clinical trial was conducted. Subjects were healthy community-dwelling adults aged 60-80 years. Testing was performed at baseline, 8, 16, and 24 weeks. The 24-week intervention consisted of 600 milligrams (mg) of SDG daily or an equivalent amount (volume) of placebo. All participants received 1000 international units of vitamin D to ensure adequate vitamin D status. Measurements consisted of blood pressure, hematology, and tolerability for safety assessments; blood oxidative stress and inflammatory biomarkers for efficacy; and cognition, muscle strength, and pain as functional outcomes. Secondary endpoints of plasma levels of lignan metabolites were analyzed by mass spectrometry. Other tests, such as bone turnover markers and fecal levels of flax cyclolinopeptides, will be performed at a later date. RESULTS: Thirty-two participants were recruited (19 intervention and 13 control) and all completed the trial. Numerous Health Canada-imposed exclusion criteria limited recruitment success. Analyses are ongoing, but the baseline data available for a number of parameters indicate no differences between treatment groups. Safety measures (vital signs) did not change from baseline and were not significantly different between treatment and placebo groups at 24 weeks. CONCLUSIONS: Preliminary results indicate that no safety concerns are associated with administering 600 mg SDG for 24 weeks to adults between the ages of 60 and 80 years. TRIAL REGISTRATION: Clinicaltrials.gov NCT01846117; https://clinicaltrials.gov/ct2/show/NCT01846117 (Archived by WebCite at http://www.webcitation.org/6nlDZNjmA) JMIR Publications 2017-02-03 /pmc/articles/PMC5315765/ /pubmed/28159728 http://dx.doi.org/10.2196/resprot.6817 Text en ©Jane Alcorn, Susan Whiting, Navita Viveky, Yunyun Di, Kerry Mansell, Sharyle Fowler, Lilian Thorpe, Ahmed Almousa, Pui Chi Cheng, Jennifer Jones, Jennifer Billinsky, Thomas Hadjistavropoulos. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 03.02.2017. https://creativecommons.org/licenses/by/2.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0/ (https://creativecommons.org/licenses/by/2.0/) ), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.
spellingShingle Protocol
Alcorn, Jane
Whiting, Susan
Viveky, Navita
Di, Yunyun
Mansell, Kerry
Fowler, Sharyle
Thorpe, Lilian
Almousa, Ahmed
Cheng, Pui Chi
Jones, Jennifer
Billinsky, Jennifer
Hadjistavropoulos, Thomas
Protocol for a 24-Week Randomized Controlled Study of Once-Daily Oral Dose of Flax Lignan to Healthy Older Adults
title Protocol for a 24-Week Randomized Controlled Study of Once-Daily Oral Dose of Flax Lignan to Healthy Older Adults
title_full Protocol for a 24-Week Randomized Controlled Study of Once-Daily Oral Dose of Flax Lignan to Healthy Older Adults
title_fullStr Protocol for a 24-Week Randomized Controlled Study of Once-Daily Oral Dose of Flax Lignan to Healthy Older Adults
title_full_unstemmed Protocol for a 24-Week Randomized Controlled Study of Once-Daily Oral Dose of Flax Lignan to Healthy Older Adults
title_short Protocol for a 24-Week Randomized Controlled Study of Once-Daily Oral Dose of Flax Lignan to Healthy Older Adults
title_sort protocol for a 24-week randomized controlled study of once-daily oral dose of flax lignan to healthy older adults
topic Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5315765/
https://www.ncbi.nlm.nih.gov/pubmed/28159728
http://dx.doi.org/10.2196/resprot.6817
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