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

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.

Study Overview

• Status: Completed
• Conditions: Post-Menopausal Women
• Intervention / Treatment: Dietary supplement: Olive Leaf Extract; Dietary supplement: Cellulose

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 Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Limburg
    • Maastricht, Limburg, Netherlands
      • Maastricht University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 (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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Olive Leaf Extract; Olive leaf extract supplementation	Dietary supplement: Olive Leaf Extract; experimental arm
Placebo Comparator: Control; Cellulose Supplementation	Dietary supplement: Cellulose; placebo comparator arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate changes in muscle strength between study product and placebo groups	Measured by a calibrated hand dynamometer.	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)	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	At baseline + after 6 weeks + after 12 weeks of supplementation

Collaborators and Investigators

• Sponsor: BioActor
• Investigators: Principal Investigator: Freddy Troost, Dr, Maastricht University

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2023
• Primary Completion (Actual): May 27, 2024
• Study Completion (Actual): May 27, 2024

Study Registration Dates

• First Submitted: December 8, 2022
• First Submitted That Met QC Criteria: February 15, 2023
• First Posted (Actual): February 27, 2023

Study Record Updates

• Last Update Posted (Actual): July 5, 2024
• Last Update Submitted That Met QC Criteria: July 3, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Supplementation; Body composition; Post-Menopause
• Other Study ID Numbers: NL81363.068.22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No