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CompletedNCT02062528BOOM3Updated Dec 9, 2015

Hot Flashes and Omega 3

An interventional study of omega-3 fatty acids and placebo in Hot Flashes, Fatty Acids and Menopause, sponsored by Vivatech. Completed at 1 site in France. Open to female participants aged 35 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-12-09.

Sponsored by Vivatech · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
136
Allocation
Randomized
Ages
35 Years and older
Sex
Female
01

Study summary

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

02

Conditions studied

  • Hot Flashes
  • Fatty Acids
  • Menopause

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Keywords

  • EPA
03

In context

Hot Flashes

293 studies on the registry are indexed under Hot Flashes; 52 are open to participants now.

This study's enrollment of 136 is above the median of 90 across 262 interventional studies indexed under Hot Flashes.

Browse Hot Flashes studies →

Lead sponsor

Vivatech is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • menopause or peri menopause
  • complaining of hot flashes
  • social security affiliation
  • informed consent form signed

Exclusion criteria

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
136 participants (actual)

Study arms

  • Experimental
    omega-3 fatty acids

    3 capsules each day during 8 weeks

    Dietary Supplement: omega-3 fatty acids

  • Placebo comparator
    placebo

    3 capsules each day during 8 weeks

    Dietary Supplement: placebo

Interventions

  • Dietary supplementomega-3 fatty acids

    highly dosed in EPA

    Also known as: groupe actif

  • Dietary supplementplacebo
06

What researchers measure

Primary outcomes

  1. hot flashes frequency

    ANOVA by repeated measures

    Time frame: 1 to 8 week

Secondary outcomes

  1. hot flashes frequency difference

    difference betwwen week8 and week4 and week0

    Time frame: 4 week and 8 week

  2. diurnal hot flashes

    ANOVA and difference

    Time frame: week 1 to 8

  3. night hot flashes

    ANOVA and difference

    Time frame: week 1 to 8

  4. vasomotors disorders

    ANOVA and differences

    Time frame: week 1 to week 8

  5. Pittsburgh Sleep Quality Index (PSQI)

    sleep quality

    Time frame: week 0 and week 8

  6. HFRDIS

    quality of life

    Time frame: week 0 and week 8

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

    quality of life

    Time frame: week 0 and week 8

  8. Weight

    Time frame: week 0 and week 8

  9. fatty acids dosage

    fatty acids dosage

    Time frame: week 0 and week 8

  10. number of adverse events

    Time frame: week 0 to week 8

07

Study locations

1 site
  • Centre d'investigation clinique CIC1406
    Grenoble Cedex9, 38043, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 9, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02062528
Lead sponsor
Vivatech
Collaborators
Centre d'Investigation Clinique de Grenoble CIC1406
Responsible party
Sponsor
First posted
Feb 13, 2014
Start date
Mar 2014
Primary completion
May 2015
Completion
Jul 2015
Last update
Dec 9, 2015

Study contacts

Jean-Luc CRACOWSKI, MD-PhD
principal investigator · Centre d'investigation clinique CIC1406

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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