Post-Menopausal WomenFEMMEDNCT05744453
The Effect of 12-week Supplementation With Olive Leaf Extract in Postmenopausal Women (FEMMED)
A study testing Olive Leaf Extract and Cellulose in people with Post-Menopausal Women, run by BioActor at 1 site in Netherlands.
Trial summary
Menopause is defined as the end of menstruation and fertility,starting 12 months after the last menstrual period.In this modern and economically developed society, most women are living for at least 20-40 years in a postmenopausal state. Read more about this study
- Who is it for?
- Ages 45 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post-Menopausal Women
- What is being tested?
- Olive Leaf Extract and Cellulose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteNetherlands
- Study dates
- 7 Feb 2023to 27 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postmenopausal women (amenorrhea over 12 months)
- Age between 45-70 years
- Body mass index (BMI) < 35 kg/m2
Who cannot join
- Use of hormone replacement therapy (estrogenic or progestogenic) in the past 3 months before T1
- Allergy to test product/control or olive leaves/olive oil
- Use of antibiotics within 3 months prior T1
- Use of probiotics or supplements containing vitamins,minerals or antioxidants four weeks prior T1 (Calcium and vitamin D supplementation are permitted)
- Use of isoflavone-derived supplements four weeks prior T1
- Regular smoking (including use of e-cigarettes)
Show all 15Show fewer
- Abuse of alcohol (alcohol consumption >20 units/week) and/or drugs
- Intention to take part in any weight loss program
- Underwent Botulinum toxin A (Botox) injection treatment near the test sites within 2 years of baseline or plan to receive this treatment during the study
- Underwent Filler injection (collagen, hyaluronic acid, etc.) near the test sites within 2 years of baseline or plan to receive this treatment during the study
- Not willing to avoid over exposure to sun or tanning session (solarium) on the test area within 30 days prior to study start and for the duration of the study (exposure after application of sunscreen allowed)
- Willing not to change the routine use of facial cream/treatment during the study duration
- Treatment with an investigational drug (phase 1-3) 180 days before the start of the study
- Diagnosed with medical conditions that might interfere with endpoints or compromise participant safety during testing (e.g. Cardiovascular diseases, diabetes, skin diseases, cancer, Parkinson's disease, Gastrointestinal diseases or abdominal surgery interfering with gastrointestinal function) to be decided by the principal investigator
- Medication intake that might interfere with endpoints or compromise participant safety during testing (e.g. Glucose-Lowering Medications such as Metformin) to be decided by the principal investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Menopause is defined as the end of menstruation and fertility,starting 12 months after the last menstrual period.In this modern and economically developed society, most women are living for at least 20-40 years in a postmenopausal state. During menopause women may experience physical, emotional, and urogenital symptoms, with a significant impact on their health.Olive leaf extract supplementation may improve quality of life in post-menopausal women.
Read the detailed description
Menopause is associated with abdominal adipose tissue accumulation and the loss of muscle mass which causes a decrease in muscle strength. Moreover, the decrease in estrogens associated with menopause increases the risk of osteoporosis. The supplementation of oleuropein, the most abundant polyphenol found in olive tree leaves, can be an effective strategy to ameliorate body composition, due to its potential to attenuate the aging-induced decrease in protein content in muscles, to enhance thermogenesis in adipose tissue and to increase serum osteocalcin, a bone turnover marker. The current study wants to investigate the effect of 12-week olive leaf extract supplementation on body composition and muscle strength, skin-aging and menopause-related quality of life in postmenopausal women (45-70 y).
- Conditions
- Post-Menopausal Women
- Being tested
- Olive Leaf Extract, Cellulose
- Keywords
- Post-Menopause, Body composition, Supplementation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olive Leaf ExtractDietary supplement
experimental arm
CelluloseDietary supplement
placebo comparator arm
| Study group | Role | What they receive |
|---|---|---|
| Olive Leaf Extract | Experimental | Olive leaf extract supplementation Receives: Dietary Supplement: Olive Leaf Extract |
| Control | Placebo comparator | Cellulose Supplementation Receives: Dietary Supplement: Cellulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in body composition (total and regional fat mass and fat free mass) measured using Dual-energy X-ray absorptiometry (DXA)
Quantified through Dual-energy X-ray absorptiometry (DXA)
Measured: At baseline + after 12 weeks of supplementation
Secondary outcomes (3)
Evaluate changes in muscle strength between study product and placebo groups
Measured by a calibrated hand dynamometer.
Measured: At baseline + after 6 weeks + after 12 weeks of supplementation
Evaluate changes in skin health between study product and placebo groups
Measured by a visual analogue scale (VAS)
Measured: At baseline + after 6 weeks + after 12 weeks of supplementation
Evaluate changes in menopause-related symptoms between study product and placebo groups
Measured by a quality of life questionnaire
Measured: At baseline + after 6 weeks + after 12 weeks of supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start7 Feb 2023
- Primary completion27 May 2024
- Study completion27 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-Menopausal WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized double-blinded placebo controlled
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioActor
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Freddy Troost, Dr, Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05744453
- Sponsor's protocol ID
- NL81363.068.22
- Acronym
- FEMMED
- Status last verified
- Jul 2024
- First submitted
- 8 Dec 2022
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lasfar A, van Stratum SLM, Imperatrice M, van Kalkeren CAJ, Scheijen JLJM, Schalkwijk CG, La Torre D, Troost FJ. Effects of olive leaf extract supplementation on systemic markers of tissue aging and remodeling in postmenopausal women: a randomized controlled trial with exploratory skin outcomes. Front Nutr. 2025 Nov 18;12:1670194. doi: 10.3389/fnut.2025.1670194. eCollection 2025.
PubMed 41340653
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05744453
- Acronym / sponsor ID
- FEMMED / NL81363.068.22
- Conditions
- Post-Menopausal Women
- Keywords
- Post-Menopause, Body composition, Supplementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- BioActorIndustry (pharma, biotech, devices)
- Study start
- 7 Feb 2023 (actual)
- Primary completion
- 27 May 2024 (actual)
- Study completion
- 27 May 2024 (actual)
- First posted
- 27 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Menopause is defined as the end of menstruation and fertility,starting 12 months after the last menstrual period.In this modern and economically developed society, most women are living for at least 20-40 years in a postmenopausal state. During menopause women may experience physical, emotional, and urogenital symptoms, with a significant impact on their health.Olive leaf extract supplementation may improve quality of life in post-menopausal women.
Detailed description
Menopause is associated with abdominal adipose tissue accumulation and the loss of muscle mass which causes a decrease in muscle strength. Moreover, the decrease in estrogens associated with menopause increases the risk of osteoporosis. The supplementation of oleuropein, the most abundant polyphenol found in olive tree leaves, can be an effective strategy to ameliorate body composition, due to its potential to attenuate the aging-induced decrease in protein content in muscles, to enhance thermogenesis in adipose tissue and to increase serum osteocalcin, a bone turnover marker. The current study wants to investigate the effect of 12-week olive leaf extract supplementation on body composition and muscle strength, skin-aging and menopause-related quality of life in postmenopausal women (45-70 y).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized double-blinded placebo controlled
| Arm | Type | Receives |
|---|---|---|
| Olive Leaf Extract | Experimental | Dietary Supplement: Olive Leaf ExtractOlive leaf extract supplementation |
| Control | Placebo comparator | Dietary Supplement: CelluloseCellulose Supplementation |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Postmenopausal women (amenorrhea over 12 months)
- Age between 45-70 years
- Body mass index (BMI) < 35 kg/m2
Key exclusion criteria (15 listed)
- Use of hormone replacement therapy (estrogenic or progestogenic) in the past 3 months before T1
- Allergy to test product/control or olive leaves/olive oil
- Use of antibiotics within 3 months prior T1
- Use of probiotics or supplements containing vitamins,minerals or antioxidants four weeks prior T1 (Calcium and vitamin D supplementation are permitted)
- Use of isoflavone-derived supplements four weeks prior T1
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Olive Leaf Extractexperimental arm | Dietary supplement | Olive Leaf Extract |
| Celluloseplacebo comparator arm | Dietary supplement | Control |
Primary outcome
Changes in body composition (total and regional fat mass and fat free mass) measured using Dual-energy X-ray absorptiometry (DXA)
Time frame: At baseline + after 12 weeks of supplementation
Quantified through Dual-energy X-ray absorptiometry (DXA)
3 secondary outcomes
Evaluate changes in muscle strength between study product and placebo groups
Time frame: At baseline + after 6 weeks + after 12 weeks of supplementation
Evaluate changes in skin health between study product and placebo groups
Time frame: At baseline + after 6 weeks + after 12 weeks of supplementation
Evaluate changes in menopause-related symptoms between study product and placebo groups
Time frame: At baseline + after 6 weeks + after 12 weeks of supplementation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- Derived from this study: PubMed 41340653Lasfar A, van Stratum SLM, Imperatrice M, van Kalkeren CAJ, Scheijen JLJM, Schalkwijk CG, La Torre D, Troost FJ. Effects of olive leaf extract supplementation on systemic markers of tissue aging and remodeling in postmenopausal women: a randomized controlled trial with exploratory skin outcomes. Front Nutr. 2025 Nov 18;12:1670194. doi: 10.3389/fnut.2025.1670194. eCollection 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Freddy Troost, Dr principal investigator
Maastricht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Olive Leaf Extract and Cellulose in people with Post-Menopausal Women, run by BioActor at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in body composition (total and regional fat mass and fat free mass) measured using Dual-energy X-ray absorptiometry (DXA) (time frame: At baseline + after 12 weeks of supplementation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05744453, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2024.