The aim of this study is to investigate the effect of 12-week of 250 mg/day of olive leaf extract (OLE) supplementation on body composition and muscle strength, skin-aging and menopause-related quality of life in post-menopausal women (45-70 y).
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
post-menopause symptoms
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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
Background summary
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.
Study objective
The aim of this study is to investigate the effect of 12-week of 250 mg/day of
olive leaf extract (OLE) supplementation on body composition and muscle
strength, skin-aging and menopause-related quality of life in post-menopausal
women (45-70 y).
Study design
This study will be a randomized, double-blind, controlled trial based on a
12-week supplementation with olive leaf extract compared to control. In a
parallel design each individual will follow either a 12-week supplementation
with OLE (INT) or a 12-week cellulose supplementation (CON).
Intervention
250 mg/day supplementation with olive leaf extract for 12 weeks
Study burden and risks
In total, 64 participants will visit the site on four occasions (one screening,
three test days) which requires a total time investment of approximately 6
hours. During the study, participants will undergo a DXA scan, undergo multiple
measurements (handgrip test, skin hair and nail assessment, blood samples) and
complete questionnaires about skin, hair and nail evaluation, menopause
symptoms and habitual physical activity. 34,5 mL of blood will be collected
from each participant during the study. Participants will be asked to ingest
one capsule a day for a supplementation period of 12 weeks.
Gaetano Martinolaan 50
Maastricht 6229GS
NL
Gaetano Martinolaan 50
Maastricht 6229GS
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL81363.068.22 |