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Completed

NCT Number: NCT02062528

Hot Flashes and Omega 3

The main objective is to evaluate the effects of omega-3 fatty acids on hot flashes frequency.

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Key information

Conditions

Hot Flashes Fatty Acids Menopause Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

35 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre d'investigation clinique CIC1406

Grenoble Cedex9, 38043, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Omega-3 fatty acids

Dietary Supplement

highly dosed in EPA

Other names: groupe actif

Placebo

Dietary Supplement

Primary outcomes

  1. hot flashes frequency

    Time frame: 1 to 8 week

    ANOVA by repeated measures

Secondary outcomes

  1. hot flashes frequency difference

    Time frame: 4 week and 8 week

    difference betwwen week8 and week4 and week0

  2. diurnal hot flashes

    Time frame: week 1 to 8

    ANOVA and difference

  3. night hot flashes

    Time frame: week 1 to 8

    ANOVA and difference

  4. vasomotors disorders

    Time frame: week 1 to week 8

    ANOVA and differences

  5. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: week 0 and week 8

    sleep quality

  6. HFRDIS

    Time frame: week 0 and week 8

    quality of life

  7. The Menopause-Specific Quality of Life (MENQOL)

    Time frame: week 0 and week 8

    quality of life

  8. Weight

    Time frame: week 0 and week 8

  9. fatty acids dosage

    Time frame: week 0 and week 8

    fatty acids dosage

  10. number of adverse events

    Time frame: week 0 to week 8

Sponsors and collaborators

Lead sponsor

Vivatech

Industry

Collaborators

  • Centre d'Investigation Clinique de Grenoble CIC1406

Registry information

Official study title

Evaluation de l'efficacité Des Acides Gras oméga 3 Hautement concentrés en EPA Sur Les bouffées de Chaleur, Chez Des Femmes en période de péri-ménopause et ménopause : étude Monocentrique, en Groupes parallèles, contrôlée, randomisée vs Placebo

Acronym: BOOM3

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 13, 2014
Registry last updated
Dec 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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