NCT02174666

Brief Summary

The aim of the project is to execute a double-blind, parallel, randomized 12-month intervention trial on postmenopausal women with osteopenia (low bone mineral density), in order to determine the effects of daily intake of fermented red clover (RC) extract on estrogen dependent bone mineral resorption when compared to placebo. Both groups will recieve equivalent daily calcium, vitamin D and magnesium supplements. The project will also assess whether bioactive compounds in RC can reduce the risk of developing cardiovascular disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 1, 2014

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

June 19, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 25, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

December 4, 2023

Status Verified

December 1, 2023

Enrollment Period

2.3 years

First QC Date

June 19, 2014

Last Update Submit

December 1, 2023

Conditions

OsteopeniaOsteoporosis

Keywords

AglyconesIsoflavonesRed cloverOsteopeniaMenopauseBone turnoverBone mineral density

Outcome Measures

Primary Outcomes (1)

  • Plasma C-terminal telopeptide (CTX)

    Bone mineral resorption biomarker.

    0 - 12 months

Secondary Outcomes (1)

  • Bone mineral density via dual energy X-ray absorptiometry

    0 - 12 months

Study Arms (2)

Red clover extract

ACTIVE COMPARATOR

Group recieving daily red clover extract containing isoflavones (80 mg/d), along with calcium (1040 mg/d), vitamin D (25µg/d) and magnesium (487mg/d).

Dietary Supplement: Red clover extract

Placebo group

PLACEBO COMPARATOR

Group recieving daily placebo extract (with no isoflavone content), calcium (1040 mg/d), vitamin D (25µg/d) and magnesium (487mg/d).

Dietary Supplement: Supplementation (placebo)

Interventions

Red clover extractDIETARY_SUPPLEMENT

Aglycone isoflavones 80mg/d

Also known as: Formononetin, Biochanin A, Genistein, Daidzein, Vitamin D, Magnesium, Calcium
Red clover extract
Supplementation (placebo)DIETARY_SUPPLEMENT
Also known as: Vitamin D, Magnesium, Calcuim
Placebo group

Eligibility Criteria

Age50 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 50-85 years, only women
  • Have osteopenia (T score between -1 and -2.5)
  • Body Mass Index (BMI) between 20 and 40

You may not qualify if:

  • Taken specific osteoporosis drugs (i.e. bisphosphonates, PTH, estrogen or strontium ranelate) in the past 3 months
  • Taken other selective estrogen receptor modulator preparations (raloxifene, tamoxifen or isoflavones) in the past 3 months
  • Participation in other clinical trials within the last 3 months
  • Previous history of cardiovascular, psychiatric, neurological, and / or kidney disease
  • Alcohol or substance abuse or acute illness
  • Blood pressure\> 160/110
  • Pregnant and breastfeeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus, Central Jutland, 8000, Denmark

Location

Related Publications (1)

  • Lambert MNT, Thybo CB, Lykkeboe S, Rasmussen LM, Frette X, Christensen LP, Jeppesen PB. Combined bioavailable isoflavones and probiotics improve bone status and estrogen metabolism in postmenopausal osteopenic women: a randomized controlled trial. Am J Clin Nutr. 2017 Sep;106(3):909-920. doi: 10.3945/ajcn.117.153353. Epub 2017 Aug 2.

    PMID: 28768651DERIVED

MeSH Terms

Conditions

Bone Diseases, MetabolicOsteoporosis

Interventions

formononetinbiochanin AGenisteindaidzeinVitamin DMagnesiumCalciumDietary Supplements

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

IsoflavonesFlavonoidsChromonesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingSecosteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsMetals, Alkaline EarthElementsInorganic ChemicalsMetals, LightMetalsBlood Coagulation FactorsBiological FactorsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Per B Jeppesen, Prof PhD

    Department of Medicine and Endocrinology MEA, Aarhus University

    PRINCIPAL INVESTIGATOR

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
Associate Prof., PhD

Study Record Dates

First Submitted

June 19, 2014

First Posted

June 25, 2014

Study Start

June 1, 2014

Primary Completion

October 1, 2016

Study Completion

November 1, 2016

Last Updated

December 4, 2023

Record last verified: 2023-12

Locations

DK(1)