The primary objective is to examine the effect of twelve weeks supplementing daily one AstaPure® Oleoresin capsule on trans epidermal water loss (TEWL) in postmenopausal women. The secondary objectives are to investigate the effects on other skin,…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
post-menopause symptoms
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The effects of AstaPure® Oleoresin on skin health levels will be assessed by
measuring transepidemial water loss (TEWL). TEWL provides information on the
integrity of the skin's protective barrier functions. The measurements are
performed by the application of a probe to the skin surface for 30 seconds.
Upon contact, the water evaporation rate (g/h/m²) is obtained. High values of
TEWL reflect a damaged skin barrier function.
Secondary outcome
The effects of AstaPure® Oleoresin on skin health levels will be furthermore
assessed by skin microbiota swaps and skin markers on tape-strips (e.g.,
collagen). In addition, other skin, hair and nail parameters will be assessed
such as wrinkles, hydration, pigmentation, erythema, hair density and hair
diameter. An additional endpoint is to assess the effect of AstaPure® on muscle
related outcomes (handgrip strength, arm curl test, sit to stand test). In a
subgroup, an exploratory outcome is to investigate the effect on extracellular
matrix (ECM) in skeletal muscle biopsies.
Background summary
Changes in the appearance and function of the skin are a general phenomenon in
old age. Additionally, age-related loss of skeletal muscle mass and function
affects up to 27% of elderly individuals. Both skin and muscle mass changes are
affected, amongst others, by the hormone estrogen. Hypoestrogenism exacerbates
the effects of aging and contributes to a higher incidence of sarcopenia in
postmenopausal women. Multiple animal and human studies have shown that
astaxanthin (present in microalgae) may improve skin function by decreasing
transepidemial water loss (TEWL). In addition, the antioxidative effects of
astaxanthin may improve muscle function of postmenopausal women.
Study objective
The primary objective is to examine the effect of twelve weeks supplementing
daily one AstaPure® Oleoresin capsule on trans epidermal water loss (TEWL) in
postmenopausal women. The secondary objectives are to investigate the effects
on other skin, hair, and nail parameters and muscle function. An exploratory
outcome is to investigate the effect of AstaPure® on extracellular matrix
(ECM).
Study design
A parallel, double-blinded, randomized controlled trial will be carried out.
The intervention period will last for twelve weeks.
Intervention
Participants will ingest daily with breakfast 80 mg microalgae oleoresin or
rapeseed oil in the form of capsules for 12 weeks.
Study burden and risks
Total study duration will be 12 weeks (and 9 additional days when participating
in the sub study). During the study blood samples will be collected (73.5 mL mL
in total), which occasionally may cause a hematoma or bruise. For participants
taking part in the sub study, three muscle biopsies and a bout of eccentric
muscle damaging exercise will be performed, which will cause muscle soreness
afterwards. Other measurements are not expected to cause side effects. Subjects
will have a total time investment of ±6.5 h for the main study and ±11 h for
taking part in the explorative substudy.
Gaetano Martinolaan 50
Maastricht 6229 GS
NL
Gaetano Martinolaan 50
Maastricht 6229 GS
NL
Listed location countries
Age
Inclusion criteria
Postmenopausal women (amenorrhea over 12 months)
Age <=70 years old
Exclusion criteria
Allergy to test product/control
Use of hormone replacement therapy (estrogenic or progestogenic) in the past 3
months before TD1
Use of probiotics or supplements containing vitamins, minerals or antioxidants
four weeks prior T1 (Calcium and vitamin D supplementation are permitted)
Use of antibiotics within 3 months prior to TD1
Having donated blood within one month before the start of the study, or
planning to donate blood during the study
Regular smoking on a weekly or biweekly basis (including use of e-cigarettes)
Abuse of alcohol (alcohol consumption >20 units/week) and/or drugs
Regular strength or endurance exercise e.g. muscle strengthening exercises in
the gym or improving aerobic capacity such as running, mountain biking,
swimming (>= 3 times per week) performed within six months prior to the study
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 before the study starts 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. skin diseases, cancer,
Gastrointestinal diseases or abdominal surgery interfering with
gastrointestinal function, diabetes, coronary heart disease, hypertension
>160/100mmHg, coagulation disorders, moderate to severe osteoarthritis of the
knee) is 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 or
Topical treatment with corticosteroids around the tested area, NSAIDs,
angiotensin-converting enzyme (ACE) inhibitors, and statins) to be decided by
the principal Investigator
Recent skeletal muscle injury less than one month before the start of the study
Inability to understand study information and/or communicate with staff
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| ClinicalTrials.gov | NCTnognietbekend |
| CCMO | NL86813.068.24 |