<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03036722</url>
  </required_header>
  <id_info>
    <org_study_id>UOReading</org_study_id>
    <nct_id>NCT03036722</nct_id>
  </id_info>
  <brief_title>Flaxseed Consumption and Bone Metabolism in Postmenopausal Women.</brief_title>
  <acronym>FLAX</acronym>
  <official_title>Effect of Phytoestrogen-rich Flaxseeds on Decreasing Bone Turnover in Postmenopausal Women Aged Between 50 -70 Years.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Reading</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Reading</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This proposed randomized double blinded, placebo-controlled, parallel trial; with two arms,&#xD;
      in females aged 50-70 years, volunteers will be postmenopausal with a BMI between 25-35&#xD;
      kg/m2. This study aims to determine the benefits of phytoestrogen-rich flaxseeds on&#xD;
      decreasing bone turnover in postmenopausal women aged over 50 years.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Osteoporosis affects approximately 1 in 3 women over the age of 50 and accounts for more days&#xD;
      spent in hospital than diabetes and breast cancer; amongst women of that age group. Aging, a&#xD;
      sedentary lifestyle, a poor diet and smoking are all risk factors. A healthy diet (including&#xD;
      food rich in calcium, vitamin D and phytoestrogens) may protect against osteoporosis and risk&#xD;
      of fractures. Phytoestrogens in the diet are of putative benefit through and post the&#xD;
      menopause. The term phytoestrogens describes a wide variety of plant food derived chemicals&#xD;
      having a structure similar to estradiol (oestrogen). The three main classes of phytoestrogens&#xD;
      are the isoflavones, the lignans and coumestans. Oil seeds are a good source of lignans, with&#xD;
      flaxseeds being particularly rich. Flaxseeds consumption has previously been associated with&#xD;
      changes in bone turnover markers in postmenopausal women.&#xD;
&#xD;
      This study therefore is designed to test the hypothesis that consumption of a quantity of&#xD;
      flaxseeds achievable in an individual's habitual diet (40g) will induce improvements in bone&#xD;
      turnover markers, mediated through the increased circulation of phytoestrogens, in&#xD;
      postmenopausal women.&#xD;
&#xD;
      . The study arms are i) A placebo control arm, volunteers consume a placebo 40g porridge&#xD;
      (matched for fibre and fat with the flaxseed product) every day over 12 weeks, or ii) 40g of&#xD;
      flaxseeds added to 40g porridge daily over a 12 week study period. Adherence to the&#xD;
      intervention will be assessed via analysis of concentrations of the mammalian lignans&#xD;
      enterolactone and enterodiol in urine. The primary outcome for the study will be changes in&#xD;
      markers of bone health. The secondary outcomes for the study will be changes in urinary and&#xD;
      plasma androgens. Volunteers will need to attend the Hugh Sinclair Unit of Human Nutrition&#xD;
      clinical unit on four occasions to facilitate screening and the study visit.&#xD;
&#xD;
      Volunteers will be required to provide a fasting blood (30ml; 2 tablespoons); 24 hr urine&#xD;
      (started the day prior to each study visit) and faecal samples at all 3 study visits&#xD;
      (baseline, weeks 6 and 12). As vitamin D status and bone turnover markers are related to bone&#xD;
      health, the volunteers will be given the opportunity to undergo an additional measurement of&#xD;
      total body composition using dual-energy x-ray absorptiometry (DXA) at baseline and week 12.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 10, 2017</start_date>
  <completion_date type="Anticipated">November 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">November 1, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Determine the benefits of phytoestrogen-rich flaxseeds on decreasing bone turnover in postmenopausal women.</measure>
    <time_frame>12 weeks</time_frame>
    <description>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)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gut microbial</measure>
    <time_frame>12 weeks</time_frame>
    <description>Observe the role of gut microbial on flaxseed metabolite.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">44</enrollment>
  <condition>Bone Loss, Age Realted</condition>
  <condition>Post Menopausal</condition>
  <arm_group>
    <arm_group_label>Flaxseed porridge group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>22 volunteer will be given 80g of a pre prepared porridge meal containing 40 g of ground (flaxseed) to consume daily.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo control porridge group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>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).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Flaxseed</intervention_name>
    <description>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).</description>
    <arm_group_label>Flaxseed porridge group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo control porridge</intervention_name>
    <description>control porridge matched for energy and fat content.</description>
    <arm_group_label>Placebo control porridge group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Postmenopausal women (self reported of final menstrual cycle occurred at least 1 year&#xD;
             ago).&#xD;
&#xD;
          -  50-70 years.&#xD;
&#xD;
          -  BMI ≥25-35 kg/m2.&#xD;
&#xD;
          -  Fasting serum Glucose &lt;7 mmol/l (not diagnosed with diabetes)&#xD;
&#xD;
          -  Fasting total cholesterol&lt;7.8 mmol/l and triacylglycerol &lt;2.3 mmol/l.&#xD;
&#xD;
          -  Normal liver and kidney function (assessed by measuring total bilirubin, uric acid,&#xD;
             creatinine and liver enzymes in the screening blood sample).&#xD;
&#xD;
          -  Not having suffered fractures of the hip, wrist or spine, osteoporosis or&#xD;
             osteomalacia.&#xD;
&#xD;
          -  Blood pressure lower than BP &lt;140/90 mmHg.&#xD;
&#xD;
          -  Not having any medical related cause that influencing bone turnover; these include:&#xD;
&#xD;
               -  Steroid medical treatment, e.g. 5 mg/ day of prednisolone.&#xD;
&#xD;
               -  Abnormal hormonal fluctuation women who self-reported previous diagnoses of&#xD;
                  thyroid disease, Thyroid hormonal abnormalities, progesterone and oestrogen high&#xD;
                  level.&#xD;
&#xD;
               -  Diagnosed with vitamin D deficiency.&#xD;
&#xD;
          -  Not suffering any cardiovascular diseases/ heart diseases e.g. stroke in the past 12&#xD;
             months.&#xD;
&#xD;
          -  Not using hormone replacement medicine e.g. oestrogen.&#xD;
&#xD;
          -  Not using any calcium or vitamin D supplements during the last 3 months.&#xD;
&#xD;
          -  Not suffering from renal or bowel disease.&#xD;
&#xD;
          -  No history of alcohol misuse based on self-reported alcohol intake and measurement of&#xD;
             liver enzymes in the screening blood sample.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who became menopausal as the result of surgery (e.x. removal of both ovaries).&#xD;
&#xD;
          -  Current smoker.&#xD;
&#xD;
          -  Anaemic, haemoglobin ≤ 115g/l or who have abnormal blood biochemistry based on&#xD;
             standard clinical cut- offs.&#xD;
&#xD;
          -  Have history of food intolerances/allergies (e.g. gluten or dairy) or intolerances&#xD;
             (e.g. lactose).&#xD;
&#xD;
          -  Received antibiotics in the previous six months.&#xD;
&#xD;
          -  Trying to lose weight by following a diet or exercise regimen designed for weight&#xD;
             loss, or taking any drug influencing appetite and any drug for weight loss for the&#xD;
             last three months.&#xD;
&#xD;
          -  Have participated in similar dietary or probiotics-containing product's clinical&#xD;
             trials within 3 months before the screening visit.&#xD;
&#xD;
          -  Using soy/isoflavone, flax oil and flax supplements.&#xD;
&#xD;
          -  Using prebiotic / probiotic during the last 6 months.&#xD;
&#xD;
          -  Excessive exercise more than three times a week, including weight bearing exercise.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mike Proven, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Ethics committee Co-ordinator</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Daniel M Commane,, PhD</last_name>
    <phone>0118 378 7108</phone>
    <email>d.m.commane@reading.ac.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Halah A Hafiz, Mcs</last_name>
    <email>H.A.M.Hafiz@pgr.reading.ac.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Reading</name>
      <address>
        <city>Reading</city>
        <state>Berkshire</state>
        <zip>RG6 6AH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Daniel M Commane, Phd</last_name>
      <email>d.m.commane@reading.ac.uk</email>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>Cosman F, de Beur SJ, LeBoff MS, Lewiecki EM, Tanner B, Randall S, Lindsay R; National Osteoporosis Foundation. Clinician's Guide to Prevention and Treatment of Osteoporosis. Osteoporos Int. 2014 Oct;25(10):2359-81. doi: 10.1007/s00198-014-2794-2. Epub 2014 Aug 15. Erratum In: Osteoporos Int. 2015 Jul;26(7):2045-7.</citation>
    <PMID>25182228</PMID>
  </reference>
  <reference>
    <citation>Foundation, N. O. (2003). Physician's guide to prevention and treatment of osteoporosis, National Osteoporosis Foundation.</citation>
  </reference>
  <reference>
    <citation>Hutchins AM, Martini MC, Olson BA, Thomas W, Slavin JL. Flaxseed consumption influences endogenous hormone concentrations in postmenopausal women. Nutr Cancer. 2001;39(1):58-65. doi: 10.1207/S15327914nc391_8.</citation>
    <PMID>11588903</PMID>
  </reference>
  <reference>
    <citation>Mei J, Yeung SS, Kung AW. High dietary phytoestrogen intake is associated with higher bone mineral density in postmenopausal but not premenopausal women. J Clin Endocrinol Metab. 2001 Nov;86(11):5217-21. doi: 10.1210/jcem.86.11.8040.</citation>
    <PMID>11701680</PMID>
  </reference>
  <reference>
    <citation>Weaver CM, Cheong JM. Soy isoflavones and bone health: the relationship is still unclear. J Nutr. 2005 May;135(5):1243-7. doi: 10.1093/jn/135.5.1243.</citation>
    <PMID>15867312</PMID>
  </reference>
  <reference>
    <citation>Go G, Tserendejid Z, Lim Y, Jung S, Min Y, Park H. The association of dietary quality and food group intake patterns with bone health status among Korean postmenopausal women: a study using the 2010 Korean National Health and Nutrition Examination Survey Data. Nutr Res Pract. 2014 Dec;8(6):662-9. doi: 10.4162/nrp.2014.8.6.662. Epub 2014 Sep 15.</citation>
    <PMID>25489406</PMID>
  </reference>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>January 26, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>May 10, 2018</last_update_submitted>
  <last_update_submitted_qc>May 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 16, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Reading</investigator_affiliation>
    <investigator_full_name>Dr Daniel Commane</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03036722
org study id: UOReading
nct id: NCT03036722
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Determine the benefits of phytoestrogen-rich flaxseeds on decreasing bone turnover in postmenopausal women.
time frame: 12 weeks
description: 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)
measure: Gut microbial
time frame: 12 weeks
description: Observe the role of gut microbial on flaxseed metabolite.
arm group label: Flaxseed porridge group
arm group type: Experimental
description: 22 volunteer will be given 80g of a pre prepared porridge meal containing 40 g of ground (flaxseed) to consume daily.
arm group label: Placebo control porridge group
arm group type: Placebo Comparator
description: 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).
intervention type: Other
intervention name: Flaxseed
description: 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).
arm group label: Flaxseed porridge group
intervention type: Other
intervention name: Placebo control porridge
description: control porridge matched for energy and fat content.
arm group label: Placebo control porridge group
criteria: 
gender: Female
minimum age: 50 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mike Proven, PhD
role: Study Chair
affiliation: Ethics committee Co-ordinator
last name: Daniel M Commane,, PhD
phone: 0118 378 7108
email: d.m.commane@reading.ac.uk
last name: Halah A Hafiz, Mcs
email: H.A.M.Hafiz@pgr.reading.ac.uk
facility: 
status: Recruiting
contact: 
country: United Kingdom
citation: Cosman F, de Beur SJ, LeBoff MS, Lewiecki EM, Tanner B, Randall S, Lindsay R; National Osteoporosis Foundation. Clinician's Guide to Prevention and Treatment of Osteoporosis. Osteoporos Int. 2014 Oct;25(10):2359-81. doi: 10.1007/s00198-014-2794-2. Epub 2014 Aug 15. Erratum In: Osteoporos Int. 2015 Jul;26(7):2045-7.
PMID: 25182228
citation: Foundation, N. O. (2003). Physician's guide to prevention and treatment of osteoporosis, National Osteoporosis Foundation.
citation: Hutchins AM, Martini MC, Olson BA, Thomas W, Slavin JL. Flaxseed consumption influences endogenous hormone concentrations in postmenopausal women. Nutr Cancer. 2001;39(1):58-65. doi: 10.1207/S15327914nc391_8.
PMID: 11588903
citation: Mei J, Yeung SS, Kung AW. High dietary phytoestrogen intake is associated with higher bone mineral density in postmenopausal but not premenopausal women. J Clin Endocrinol Metab. 2001 Nov;86(11):5217-21. doi: 10.1210/jcem.86.11.8040.
PMID: 11701680
citation: Weaver CM, Cheong JM. Soy isoflavones and bone health: the relationship is still unclear. J Nutr. 2005 May;135(5):1243-7. doi: 10.1093/jn/135.5.1243.
PMID: 15867312
citation: Go G, Tserendejid Z, Lim Y, Jung S, Min Y, Park H. The association of dietary quality and food group intake patterns with bone health status among Korean postmenopausal women: a study using the 2010 Korean National Health and Nutrition Examination Survey Data. Nutr Res Pract. 2014 Dec;8(6):662-9. doi: 10.4162/nrp.2014.8.6.662. Epub 2014 Sep 15.
PMID: 25489406
responsible party type: Principal Investigator
investigator affiliation: University of Reading
investigator full name: Dr Daniel Commane
investigator title: Principal Investigator
sharing ipd: Undecided