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Flaxseed Consumption and Bone Metabolism in Postmenopausal Women. (FLAX)

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ClinicalTrials.gov Identifier: NCT03036722
Recruitment Status : Recruiting
First Posted : January 30, 2017
Last Update Posted : May 16, 2018
Sponsor:
Information provided by (Responsible Party):
Dr Daniel Commane, University of Reading

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.

Condition or disease Intervention/treatment Phase
Bone Loss, Age Realted Post Menopausal Other: Flaxseed Other: Placebo control porridge Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.
Other: Flaxseed
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.




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Gut microbial [ Time Frame: 12 weeks ]
    Observe the role of gut microbial on flaxseed metabolite.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Postmenopausal women (self reported of final menstrual cycle occurred at least 1 year ago).
  • 50-70 years.
  • BMI ≥25-35 kg/m2.
  • Fasting serum Glucose <7 mmol/l (not diagnosed with diabetes)
  • Fasting total cholesterol<7.8 mmol/l and triacylglycerol <2.3 mmol/l.
  • Normal liver and kidney function (assessed by measuring total bilirubin, uric acid, creatinine and liver enzymes in the screening blood sample).
  • Not having suffered fractures of the hip, wrist or spine, osteoporosis or osteomalacia.
  • Blood pressure lower than BP <140/90 mmHg.
  • Not having any medical related cause that influencing bone turnover; these include:

    • Steroid medical treatment, e.g. 5 mg/ day of prednisolone.
    • Abnormal hormonal fluctuation women who self-reported previous diagnoses of thyroid disease, Thyroid hormonal abnormalities, progesterone and oestrogen high level.
    • Diagnosed with vitamin D deficiency.
  • Not suffering any cardiovascular diseases/ heart diseases e.g. stroke in the past 12 months.
  • Not using hormone replacement medicine e.g. oestrogen.
  • Not using any calcium or vitamin D supplements during the last 3 months.
  • Not suffering from renal or bowel disease.
  • No history of alcohol misuse based on self-reported alcohol intake and measurement of liver enzymes in the screening blood sample.

Exclusion Criteria:

  • Women who became menopausal as the result of surgery (e.x. removal of both ovaries).
  • Current smoker.
  • Anaemic, haemoglobin ≤ 115g/l or who have abnormal blood biochemistry based on standard clinical cut- offs.
  • Have history of food intolerances/allergies (e.g. gluten or dairy) or intolerances (e.g. lactose).
  • Received antibiotics in the previous six months.
  • Trying to lose weight by following a diet or exercise regimen designed for weight loss, or taking any drug influencing appetite and any drug for weight loss for the last three months.
  • Have participated in similar dietary or probiotics-containing product's clinical trials within 3 months before the screening visit.
  • Using soy/isoflavone, flax oil and flax supplements.
  • Using prebiotic / probiotic during the last 6 months.
  • Excessive exercise more than three times a week, including weight bearing exercise.

Information from the National Library of Medicine

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


Contacts
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Contact: Daniel M Commane,, PhD 0118 378 7108 d.m.commane@reading.ac.uk
Contact: Halah A Hafiz, Mcs H.A.M.Hafiz@pgr.reading.ac.uk

Locations
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United Kingdom
University of Reading Recruiting
Reading, Berkshire, United Kingdom, RG6 6AH
Contact: Daniel M Commane, Phd       d.m.commane@reading.ac.uk   
Sponsors and Collaborators
University of Reading
Investigators
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Study Chair: Mike Proven, PhD Ethics committee Co-ordinator

Publications:
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Responsible Party: Dr Daniel Commane, Principal Investigator, University of Reading
ClinicalTrials.gov Identifier: NCT03036722     History of Changes
Other Study ID Numbers: UOReading
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: May 16, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No