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

May 10, 2018 updated by: Dr Daniel Commane, University of Reading

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gut microbial
Time Frame: 12 weeks
Observe the role of gut microbial on flaxseed metabolite.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Reading

Investigators

  • Study Chair: Mike Proven, PhD, Ethics committee Co-ordinator

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 10, 2017

Primary Completion (ANTICIPATED)

November 1, 2018

Study Completion (ANTICIPATED)

November 1, 2018

Study Registration Dates

First Submitted

January 26, 2017

First Submitted That Met QC Criteria

January 26, 2017

First Posted (ESTIMATE)

January 30, 2017

Study Record Updates

Last Update Posted (ACTUAL)

May 16, 2018

Last Update Submitted That Met QC Criteria

May 10, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • UOReading

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Post Menopausal

Clinical Trials on Flaxseed

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe