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Hot Flashes and Omega 3 (BOOM3)

This study has been completed.
Centre d'Investigation Clinique de Grenoble CIC1406
Information provided by (Responsible Party):
Vivatech Identifier:
First received: February 12, 2014
Last updated: December 8, 2015
Last verified: December 2015
The main objective is to evaluate the effects of omega-3 fatty acids on hot flashes frequency.

Condition Intervention
Hot Flashes
Fatty Acids
Dietary Supplement: omega-3 fatty acids
Dietary Supplement: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Further study details as provided by Vivatech:

Primary Outcome Measures:
  • hot flashes frequency [ Time Frame: 1 to 8 week ]
    ANOVA by repeated measures

Secondary Outcome Measures:
  • hot flashes frequency difference [ Time Frame: 4 week and 8 week ]
    difference betwwen week8 and week4 and week0

  • diurnal hot flashes [ Time Frame: week 1 to 8 ]
    ANOVA and difference

  • night hot flashes [ Time Frame: week 1 to 8 ]
    ANOVA and difference

  • vasomotors disorders [ Time Frame: week 1 to week 8 ]
    ANOVA and differences

  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: week 0 and week 8 ]
    sleep quality

  • HFRDIS [ Time Frame: week 0 and week 8 ]
    quality of life

  • The Menopause-Specific Quality of Life (MENQOL) [ Time Frame: week 0 and week 8 ]
    quality of life

  • Weight [ Time Frame: week 0 and week 8 ]
  • fatty acids dosage [ Time Frame: week 0 and week 8 ]
    fatty acids dosage

  • number of adverse events [ Time Frame: week 0 to week 8 ]

Enrollment: 136
Study Start Date: March 2014
Study Completion Date: July 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: omega-3 fatty acids
3 capsules each day during 8 weeks
Dietary Supplement: omega-3 fatty acids
highly dosed in EPA
Other Name: groupe actif
Placebo Comparator: placebo
3 capsules each day during 8 weeks
Dietary Supplement: placebo


Ages Eligible for Study:   35 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts 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)
  Contacts and Locations
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Please refer to this study by its identifier: NCT02062528

Centre d'investigation clinique CIC1406
GRENOBLE cedex9, France, 38043
Sponsors and Collaborators
Centre d'Investigation Clinique de Grenoble CIC1406
Principal Investigator: Jean-Luc CRACOWSKI, MD-PhD Centre d'investigation clinique CIC1406
  More Information

Responsible Party: Vivatech Identifier: NCT02062528     History of Changes
Other Study ID Numbers: DCIC 13 15
Study First Received: February 12, 2014
Last Updated: December 8, 2015

Keywords provided by Vivatech:

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms processed this record on April 25, 2017