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.
Completed
- Conditions
- post-menopause symptomsmenopause
- Registration Number
- NL-OMON53755
- Lead Sponsor
- BioActor BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 86
Inclusion Criteria
Postmenopausal women (amenorrhea over 12 months) Age between 45-70 years Body
mass index (BMI) < 35 kg/m2
Exclusion Criteria
Use of hormone replacement therapy, use of supplements or
medication affecting main outcomes, smoking.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary aim of this study is to determine whether daily supplementation of<br /><br>olive leaf extract over a 12-week period leads to a change in body composition.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The effects of 12 weeks of daily olive leaf extract supplementation, compared<br /><br>to control, on the following parameters will be assessed:<br /><br>Muscle strength assessed by handgrip test.<br /><br>Skin elasticity and firmness as determined by a probe system<br /><br>Self-assessed Skin, hair and nail quality as determined by VAS scale<br /><br>questionnaire<br /><br>Skin, hair and nail parameters as determined by an additional probe system<br /><br>(C-Cube probe)<br /><br>Postmenopause Symptoms as determined by MENQOL and HFI Questionnaires<br /><br>Physical activity as determined by the International Physical Activity<br /><br>Questionnaire (IPAQ)<br /><br>Serum lipid profile, fasting glucose and insulin, myostatin and biomarkers of<br /><br>collagen and elastin dynamics measured with ELISA<br /><br>Dietary habits as assessed by a 3-day food record</p><br>