Mucous Membranes
Conditions
Keywords
sea buckthorn, mucous membrane, dryness, metabolic syndrome, vaginal atrophy
Brief summary
Aim of this study is to investigate the effects of intake of sea buckthorn oil on mucous membranes
Interventions
DIETARY_SUPPLEMENTSea buckthorn oil
DIETARY_SUPPLEMENTPlacebo oil
Sponsors
The Finnish Funding Agency for Technology and Innovation
Aromtech Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
55 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* women experiencing vaginal dryness * 55-75 years of age * at least 12 months from menstruation
Exclusion criteria
* use of estrogen replacement therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in dryness related symptoms of genital mucous membranes | Interviews at baseline, at 2 months, at 3 moths (end of intervention), and daily during the study (symptom logbooks) | Interview for symptom score at baseline and study visits and a daily symptom logbook during the intervention |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in vaginal pH | At baseline, at 3 months (end of intervention) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in vaginal health index, vaginal dryness, vaginal maturity index, symptoms of dryness in other mucous membranes, markers of inflammation, oxidative stress and metabolic disorder in the circulation | At baseline, at 3 months (end of intervention) | * Vaginal health index: index score, change from baseline * Vaginal dryness: moistening of pH test strip, change from baseline * Vaginal maturity index: change from baseline * Symptoms of dryness in other mucous membranes: daily symptom logbook during the intervention * Markers of inflammation, oxidative stress and metabolic disorders: analysis from serum/plasma, change from baseline |
Countries
Finland
Outcome results
None listed