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The effect of 12-week supplementation with olive leaf extract (OLE) on body composition and muscle strength, skin-aging and menopause-related quality of life in postmenopausal women (45-70 y); a randomized controlled trial.

The effect of 12-week supplementation with olive leaf extract (OLE) on body composition and muscle strength, skin-aging and menopause-related quality of life in postmenopausal women (45-70 y); a randomized controlled trial. - FEMMED Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON53755
Enrollment
86
Registered
2022-11-10
Start date
2023-02-07
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

post-menopause symptoms menopause

Interventions

250 mg/day supplementation with olive leaf extract for 12 weeks

Sponsors

BioActor BV
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Postmenopausal women (amenorrhea over 12 months) Age between 45-70 years Body mass index (BMI)

Exclusion criteria

Exclusion criteria: Use of hormone replacement therapy, use of supplements or medication affecting main outcomes, smoking.

Design outcomes

Primary

MeasureTime frame
The primary aim of this study is to determine whether daily supplementation of olive leaf extract over a 12-week period leads to a change in body composition.

Secondary

MeasureTime frame
The effects of 12 weeks of daily olive leaf extract supplementation, compared to control, on the following parameters will be assessed: Muscle strength assessed by handgrip test. Skin elasticity and firmness as determined by a probe system Self-assessed Skin, hair and nail quality as determined by VAS scale questionnaire Skin, hair and nail parameters as determined by an additional probe system (C-Cube probe) Postmenopause Symptoms as determined by MENQOL and HFI Questionnaires Physical activity as determined by the International Physical Activity Questionnaire (IPAQ) Serum lipid profile, fasting glucose and insulin, myostatin and biomarkers of collagen and elastin dynamics measured with ELISA Dietary habits as assessed by a 3-day food record

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)