NCT03036722

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 30, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

May 10, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

May 16, 2018

Status Verified

May 1, 2018

Enrollment Period

1.5 years

First QC Date

January 26, 2017

Last Update Submit

May 10, 2018

Conditions

Bone Loss, Age RealtedPost Menopausal

Outcome Measures

Primary Outcomes (1)

  • 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)

    12 weeks

Secondary Outcomes (1)

  • Gut microbial

    12 weeks

Study Arms (2)

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.

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).

Other: Placebo control porridge

Interventions

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).

Flaxseed porridge group
Placebo control porridgeOTHER

control porridge matched for energy and fat content.

Placebo control porridge group

Eligibility Criteria

Age50 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Postmenopausal women (self reported of final menstrual cycle occurred at least 1 year ago).
  • 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.
  • +2 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Reading

Reading, Berkshire, RG6 6AH, United Kingdom

RECRUITING

Related Publications (6)

  • 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.

    PMID: 25182228BACKGROUND

  • Foundation, N. O. (2003). Physician's guide to prevention and treatment of osteoporosis, National Osteoporosis Foundation.

    BACKGROUND

  • 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: 11588903BACKGROUND

  • 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: 11701680BACKGROUND

  • 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: 15867312BACKGROUND

  • 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: 25489406BACKGROUND

MeSH Terms

Conditions

Bone Diseases, Metabolic

Interventions

Linseed Oil

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Fats, UnsaturatedFatsLipidsPlant OilsOilsPlant PreparationsBiological ProductsComplex Mixtures

Study Officials

  • Mike Proven, PhD

    Ethics committee Co-ordinator

    STUDY CHAIR

Central Study Contacts

Daniel M Commane,, PhD

CONTACT

0118 378 7108d.m.commane@reading.ac.uk

Halah A Hafiz, Mcs

CONTACT

H.A.M.Hafiz@pgr.reading.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 26, 2017

First Posted

January 30, 2017

Study Start

May 10, 2017

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

May 16, 2018

Record last verified: 2018-05

Locations

GB(1)