Bone Loss, Age RealtedFLAXNCT03036722
Flaxseed Consumption and Bone Metabolism in Postmenopausal Women.
A study testing Flaxseed in people with Bone Loss, Age Realted and Post Menopausal, run by University of Reading at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bone Loss, Age Realted, Post Menopausal
- What is being tested?
- Flaxseed
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 May 2017to 1 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Halah A Hafiz, Mcs contact
United Kingdom1 site, 1 recruiting
- Recruiting
University of Reading
Reading, Berkshire, RG6 6AH
Daniel M Commane, Phd, d.m.commane@reading.ac.uk
About this study
Official title: Effect of Phytoestrogen-rich Flaxseeds on Decreasing Bone Turnover in Postmenopausal Women Aged Between 50 -70 Years.
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.
Read the 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.
- Conditions
- Bone Loss, Age Realted, Post Menopausal
- Being tested
- Flaxseed, Placebo control porridge
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlaxseedOther
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 control porridgeOther
control porridge matched for energy and fat content.
| Study group | Role | What they receive |
|---|---|---|
| Flaxseed porridge group | Experimental | 22 volunteer will be given 80g of a pre prepared porridge meal containing 40 g of ground (flaxseed) to consume daily. Receives: Other: Flaxseed |
| Placebo control porridge group | Placebo comparator | 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). Receives: Other: Placebo control porridge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the benefits of phytoestrogen-rich flaxseeds on decreasing bone turnover in postmenopausal women.
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)
Measured: 12 weeks
Secondary outcomes (1)
Gut microbial
Observe the role of gut microbial on flaxseed metabolite.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2017 (estimated)
- Study start10 May 2017
- Primary completion1 Nov 2018 (estimated)
- Study completion1 Nov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Bone Loss, Age RealtedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Daniel Commane, University of Reading
- Investigators
- Mike Proven, PhD, Study chair, Ethics committee Co-ordinator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03036722
- Sponsor's protocol ID
- UOReading
- Acronym
- FLAX
- Status last verified
- May 2018
- First submitted
- 26 Jan 2017
- Last updated
- 16 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 25182228Foundation, N. O. (2003). Physician's guide to prevention and treatment of osteoporosis, National Osteoporosis Foundation.
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.
PubMed 11588903Mei 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.
PubMed 11701680Weaver 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.
PubMed 15867312Go 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.
PubMed 25489406
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Phytoestrogen-rich Flaxseeds on Decreasing Bone Turnover in Postmenopausal Women Aged Between 50 -70 Years.
- ClinicalTrials.gov ID
- NCT03036722
- Acronym / sponsor ID
- FLAX / UOReading
- Conditions
- Bone Loss, Age Realted, Post Menopausal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Study start
- 10 May 2017 (actual)
- Primary completion
- 1 Nov 2018 (estimated)
- Study completion
- 1 Nov 2018 (estimated)
- First posted
- 30 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flaxseed porridge group | Experimental | Other: Flaxseed22 volunteer will be given 80g of a pre prepared porridge meal containing 40 g of ground (flaxseed) to consume daily. |
| Placebo control porridge group | Placebo comparator | Other: Placebo control porridge22 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). |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FlaxseedFlaxseed 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). | Other | Flaxseed porridge group |
| Placebo control porridgecontrol porridge matched for energy and fat content. | Other | Placebo control porridge group |
Primary outcome
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)
1 secondary outcome
Gut microbial
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2018.
- Background: PubMed 25182228Cosman 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.
- BackgroundFoundation, N. O. (2003). Physician's guide to prevention and treatment of osteoporosis, National Osteoporosis Foundation.
- Background: PubMed 11588903Hutchins 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.
- Background: PubMed 11701680Mei 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.
- Background: PubMed 15867312Weaver 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.
- Background: PubMed 25489406Go 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Halah A Hafiz, Mcs contact
Mike Proven, PhD study chair
Ethics committee Co-ordinator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flaxseed in people with Bone Loss, Age Realted and Post Menopausal, run by University of Reading at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel M Commane,, PhD (0118 378 7108, d.m.commane@reading.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the benefits of phytoestrogen-rich flaxseeds on decreasing bone turnover in postmenopausal women. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03036722, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2018; AzTrials last refreshed its copy on 6 Nov 2026.