The Effect of 12-week Supplementation With Olive Leaf Extract in Postmenopausal Women (FEMMED)

NCT05744453 | Completed DMC

• 1 other identifier: NL81363.068.22
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Post-Menopausal Women

Keywords

Post-Menopause; Body composition; Supplementation

Outcome Measures

Primary Outcomes (1)

• 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)

  At baseline + after 12 weeks of supplementation

Secondary Outcomes (3)

• Evaluate changes in muscle strength between study product and placebo groups

  At baseline + after 6 weeks + after 12 weeks of supplementation

• Evaluate changes in skin health between study product and placebo groups

  At baseline + after 6 weeks + after 12 weeks of supplementation

• Evaluate changes in menopause-related symptoms between study product and placebo groups

  At baseline + after 6 weeks + after 12 weeks of supplementation

Study Arms (2)

Olive Leaf Extract

EXPERIMENTAL

Olive leaf extract supplementation

Dietary Supplement: Olive Leaf Extract

Control

PLACEBO COMPARATOR

Cellulose Supplementation

Dietary Supplement: Cellulose

Interventions

Olive Leaf Extract DIETARY_SUPPLEMENT

experimental arm

Olive Leaf Extract

Cellulose DIETARY_SUPPLEMENT

placebo comparator arm

Control

Eligibility Criteria

• Age: 45 Years - 70 Years
• Gender Eligibility Details: Post-Menopausal Symptoms
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal women (amenorrhea over 12 months)
• Age between 45-70 years
• Body mass index (BMI) \< 35 kg/m2

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• BioActor: lead

Study Sites (1)

Maastricht University

Maastricht, Limburg, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 41340653 DERIVED

MeSH Terms

Interventions

olive leaf extract; Cellulose

Intervention Hierarchy (Ancestors)

Glucans; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Freddy Troost, Dr

  Maastricht University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Block Randomization
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized double-blinded placebo controlled

Study Record Dates

• First Submitted: December 8, 2022
• First Posted: February 27, 2023
• Study Start: February 7, 2023
• Primary Completion: May 27, 2024
• Study Completion: May 27, 2024
• Last Updated: July 5, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)