Effects of omega-7 sea buckthorn oil capsule on mucous membranes of post-menopausal women [omega 7-tyrniöljykapseleiden käyttö vaihdevuosioireiden, emättimen ja muiden limakalvojen kuivuuden ja virtsatieoireiden hoidossa]

ISRCTN	ISRCTN91680999
DOI	https://doi.org/10.1186/ISRCTN91680999
Protocol serial number	SBRE2008
Sponsor	Turku University Central Hospital (Finland)
Funders	Finnish Funding Agency for Technology and Innovation (TEKES) (Finland), Aromtech Ltd (Finland)

Submission date: 15/08/2008
Registration date: 21/08/2008
Last edited: 21/08/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Baoru Yang
Scientific

Aromtech Ltd
Tykistökatu 4 D (DIO)
Turku
20520
Finland

Study information

Primary study design	Interventional
Study design	A randomised, double blind, placebo-controlled, single-centre parallel study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study acronym	SBMUCOS2008
Study objectives	Increased oxidative stress to the secretion glands and the cells of mucous membranes is part of the mechanism of ageing-related dryness and inflammation in the mucous membranes of female subjects. Sea buckthorn oil supports the health of mucous membranes by supplying the body with lipid nutrients required for maintaining the structure and function and for regeneration of mucous membranes. High content of antioxidants in sea buckthorn oil will increase the antioxidant capacity and reduce lipid peroxidation of plasma. Supplementation with sea buckthorn oil will decrease the plasma C-reactive protein (CRP) level indicating reduced inflammation in the body.
Ethics approval(s)	Ethics approval received from the Ethical Committee of the Hospital District of Southwest Finland on the 5th August 2008 (ref: 7/2008 § 254).
Health condition(s) or problem(s) studied	Mucosa membrane dryness
Intervention	Group one: omega 7 capsules 2 x 2 capsules per day for 4 months Group two: placebo capsules (medium chain triglycerides), 2 x 2 capsules per day for 4 months
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Sea buckthorn oil
Primary outcome measure(s)	1. Dryness, itching, pain, burning and/or inflammation in the mucosa of the genital tract at baseline, after one and four months of supplementation 2. Vaginal PH at baseline, after one and four months of supplementation 3. Maturation index of vaginal mucosa at baseline, after one and four months of supplementation
Key secondary outcome measure(s)	1. Plasma total anoxidative capacity at baseline, after one and four months of supplementation 2. Plasma isoprostane level at baseline, after one and four months of supplementation 3. Plasma C-reactive protein level at baseline, after one and four months of supplementation
Completion date	30/03/2009

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	100
Key inclusion criteria	1. Healthy post-menopausal females aged 55 - 70 years 2. Dryness, itching, pain, burning and/or inflammation in the mucosa of the genital tract 3. Problem of the genital tract mucosa shall not have clear association with severe diseases
Key exclusion criteria	1. Severe diseases and/or receiving systematic medications such as hormone replacement therapy, anti-inflammatory and cholesterol lowering drugs 2. Diabetes 3. Hormonal, renal, haematological, or hepatic dysfunction
Date of first enrolment	18/08/2008
Date of final enrolment	30/03/2009

Locations

Countries of recruitment

Finland

Study participating centre

Aromtech Ltd

Turku
20520
Finland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes