Fatty Acids, Hot Flashes, Menopause
Conditions
Keywords
EPA
Brief summary
The main objective is to evaluate the effects of omega-3 fatty acids on hot flashes frequency.
Interventions
DIETARY_SUPPLEMENTomega-3 fatty acids
highly dosed in EPA
DIETARY_SUPPLEMENTplacebo
Sponsors
Centre d'Investigation Clinique de Grenoble CIC1406
Vivatech
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
35 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* menopause or peri menopause * complaining of hot flashes * social security affiliation * informed consent form signed
Exclusion criteria
* primary pathology which can lead to hot flashes * allergy to omega-3 fatty acids * allergy to sea products * High consumption of fat fish or produced by the sea * iatrogenic hot flashes * actual omega-3 fatty acids consumption or in the 3 last months. * consumption of drug or other products for hot flashes in the last month * protected persons (L1121-5 to L1121-8 of French Public health code)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| hot flashes frequency | 1 to 8 week | ANOVA by repeated measures |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| diurnal hot flashes | week 1 to 8 | ANOVA and difference |
| night hot flashes | week 1 to 8 | ANOVA and difference |
| vasomotors disorders | week 1 to week 8 | ANOVA and differences |
| Pittsburgh Sleep Quality Index (PSQI) | week 0 and week 8 | sleep quality |
| hot flashes frequency difference | 4 week and 8 week | difference betwwen week8 and week4 and week0 |
| The Menopause-Specific Quality of Life (MENQOL) | week 0 and week 8 | quality of life |
| Weight | week 0 and week 8 | — |
| fatty acids dosage | week 0 and week 8 | fatty acids dosage |
| number of adverse events | week 0 to week 8 | — |
| HFRDIS | week 0 and week 8 | quality of life |
Countries
France
Outcome results
None listed