menopause
Conditions
Interventions
Participants will ingest daily with breakfast 80 mg microalgae oleoresin or
rapeseed oil in the form of capsules for 12 weeks.
Sponsors
Solabia nutrition
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Postmenopausal women (amenorrhea over 12 months) Age
Exclusion criteria
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Netherlands
Contacts
Public ContactK Hoo
Solabia nutrition
Outcome results
None listed