Flaxseed Consumption and Bone Metabolism in Postmenopausal Women. (FLAX)
|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
|Condition or disease||Intervention/treatment||Phase|
|Bone Loss, Age Realted Post Menopausal||Other: Flaxseed Other: Placebo control porridge||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effect of Phytoestrogen-rich Flaxseeds on Decreasing Bone Turnover in Postmenopausal Women Aged Between 50 -70 Years.|
|Actual Study Start Date :||May 10, 2017|
|Estimated Primary Completion Date :||November 1, 2018|
|Estimated Study Completion Date :||November 1, 2018|
Experimental: Flaxseed porridge group
22 volunteer will be given 80g of a pre prepared porridge meal containing 40 g of ground (flaxseed) to consume daily.
Flaxseed is a member of the genus Linum in the family Linaceae. It is a food and fiber crop and it occurs in two basic varieties: brown and yellow or golden (also known as golden linseeds).
Placebo Comparator: Placebo control porridge group
22 volunteer will be given 78.5g preprepared control porridge matched for energy and fat content to consume daily ( Matching food products: 22g MCT (medium chain Triglyceride), 5.5g pure egg white powder, 11g cream of rice).
Other: Placebo control porridge
control porridge matched for energy and fat content.
- 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)
- Gut microbial [ Time Frame: 12 weeks ]Observe the role of gut microbial on flaxseed metabolite.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03036722
|Contact: Daniel M Commane,, PhD||0118 378 firstname.lastname@example.org|
|Contact: Halah A Hafiz, Mcs||H.A.M.Hafiz@pgr.reading.ac.uk|
|University of Reading||Recruiting|
|Reading, Berkshire, United Kingdom, RG6 6AH|
|Contact: Daniel M Commane, Phd email@example.com|
|Study Chair:||Mike Proven, PhD||Ethics committee Co-ordinator|