Flaxseed Consumption and Bone Metabolism in Postmenopausal Women. (FLAX)
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ClinicalTrials.gov Identifier: NCT03036722 |
Recruitment Status : Unknown
Verified May 2018 by Dr Daniel Commane, University of Reading.
Recruitment status was: Recruiting
First Posted : January 30, 2017
Last Update Posted : May 16, 2018
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Tracking Information | |||||
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First Submitted Date ICMJE | January 26, 2017 | ||||
First Posted Date ICMJE | January 30, 2017 | ||||
Last Update Posted Date | May 16, 2018 | ||||
Actual Study Start Date ICMJE | May 10, 2017 | ||||
Estimated Primary Completion Date | November 1, 2018 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Determine the benefits of phytoestrogen-rich flaxseeds on decreasing bone turnover in postmenopausal women. [ Time Frame: 12 weeks ] To observe the effect of consuming 40g of flaxseeds/ daily for 12 weeks on bone health of postmenopausal women by measuring some markers of bone resorption and formation 3 during the study period (baseline, 6 and 12 week)
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
Gut microbial [ Time Frame: 12 weeks ] Observe the role of gut microbial on flaxseed metabolite.
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Flaxseed Consumption and Bone Metabolism in Postmenopausal Women. | ||||
Official Title ICMJE | Effect of Phytoestrogen-rich Flaxseeds on Decreasing Bone Turnover in Postmenopausal Women Aged Between 50 -70 Years. | ||||
Brief Summary | This proposed randomized double blinded, placebo-controlled, parallel trial; with two arms, in females aged 50-70 years, volunteers will be postmenopausal with a BMI between 25-35 kg/m2. This study aims to determine the benefits of phytoestrogen-rich flaxseeds on decreasing bone turnover in postmenopausal women aged over 50 years. | ||||
Detailed Description | Osteoporosis affects approximately 1 in 3 women over the age of 50 and accounts for more days spent in hospital than diabetes and breast cancer; amongst women of that age group. Aging, a sedentary lifestyle, a poor diet and smoking are all risk factors. A healthy diet (including food rich in calcium, vitamin D and phytoestrogens) may protect against osteoporosis and risk of fractures. Phytoestrogens in the diet are of putative benefit through and post the menopause. The term phytoestrogens describes a wide variety of plant food derived chemicals having a structure similar to estradiol (oestrogen). The three main classes of phytoestrogens are the isoflavones, the lignans and coumestans. Oil seeds are a good source of lignans, with flaxseeds being particularly rich. Flaxseeds consumption has previously been associated with changes in bone turnover markers in postmenopausal women. This study therefore is designed to test the hypothesis that consumption of a quantity of flaxseeds achievable in an individual's habitual diet (40g) will induce improvements in bone turnover markers, mediated through the increased circulation of phytoestrogens, in postmenopausal women. . The study arms are i) A placebo control arm, volunteers consume a placebo 40g porridge (matched for fibre and fat with the flaxseed product) every day over 12 weeks, or ii) 40g of flaxseeds added to 40g porridge daily over a 12 week study period. Adherence to the intervention will be assessed via analysis of concentrations of the mammalian lignans enterolactone and enterodiol in urine. The primary outcome for the study will be changes in markers of bone health. The secondary outcomes for the study will be changes in urinary and plasma androgens. Volunteers will need to attend the Hugh Sinclair Unit of Human Nutrition clinical unit on four occasions to facilitate screening and the study visit. Volunteers will be required to provide a fasting blood (30ml; 2 tablespoons); 24 hr urine (started the day prior to each study visit) and faecal samples at all 3 study visits (baseline, weeks 6 and 12). As vitamin D status and bone turnover markers are related to bone health, the volunteers will be given the opportunity to undergo an additional measurement of total body composition using dual-energy x-ray absorptiometry (DXA) at baseline and week 12. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Unknown status | ||||
Estimated Enrollment ICMJE |
44 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | November 1, 2018 | ||||
Estimated Primary Completion Date | November 1, 2018 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 50 Years to 70 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United Kingdom | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03036722 | ||||
Other Study ID Numbers ICMJE | UOReading | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Dr Daniel Commane, University of Reading | ||||
Study Sponsor ICMJE | University of Reading | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | University of Reading | ||||
Verification Date | May 2018 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |