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Hot Flashes and Omega 3 (BOOM3)

Primary Purpose

Hot Flashes, Fatty Acids, Menopause

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
omega-3 fatty acids
placebo
Sponsored by
Vivatech
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hot Flashes focused on measuring EPA

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • Centre d'investigation clinique CIC1406

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

omega-3 fatty acids

placebo

Arm Description

3 capsules each day during 8 weeks

3 capsules each day during 8 weeks

Outcomes

Primary Outcome Measures

hot flashes frequency
ANOVA by repeated measures

Secondary Outcome Measures

hot flashes frequency difference
difference betwwen week8 and week4 and week0
diurnal hot flashes
ANOVA and difference
night hot flashes
ANOVA and difference
vasomotors disorders
ANOVA and differences
Pittsburgh Sleep Quality Index (PSQI)
sleep quality
HFRDIS
quality of life
The Menopause-Specific Quality of Life (MENQOL)
quality of life
Weight
fatty acids dosage
fatty acids dosage
number of adverse events

Full Information

First Posted
February 12, 2014
Last Updated
December 8, 2015
Sponsor
Vivatech
Collaborators
Centre d'Investigation Clinique de Grenoble CIC1406
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1. Study Identification

Unique Protocol Identification Number
NCT02062528
Brief Title
Hot Flashes and Omega 3
Acronym
BOOM3
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vivatech
Collaborators
Centre d'Investigation Clinique de Grenoble CIC1406

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hot Flashes, Fatty Acids, Menopause
Keywords
EPA

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
omega-3 fatty acids
Arm Type
Experimental
Arm Description
3 capsules each day during 8 weeks
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
3 capsules each day during 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
omega-3 fatty acids
Other Intervention Name(s)
groupe actif
Intervention Description
highly dosed in EPA
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
hot flashes frequency
Description
ANOVA by repeated measures
Time Frame
1 to 8 week
Secondary Outcome Measure Information:
Title
hot flashes frequency difference
Description
difference betwwen week8 and week4 and week0
Time Frame
4 week and 8 week
Title
diurnal hot flashes
Description
ANOVA and difference
Time Frame
week 1 to 8
Title
night hot flashes
Description
ANOVA and difference
Time Frame
week 1 to 8
Title
vasomotors disorders
Description
ANOVA and differences
Time Frame
week 1 to week 8
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
sleep quality
Time Frame
week 0 and week 8
Title
HFRDIS
Description
quality of life
Time Frame
week 0 and week 8
Title
The Menopause-Specific Quality of Life (MENQOL)
Description
quality of life
Time Frame
week 0 and week 8
Title
Weight
Time Frame
week 0 and week 8
Title
fatty acids dosage
Description
fatty acids dosage
Time Frame
week 0 and week 8
Title
number of adverse events
Time Frame
week 0 to week 8

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Luc CRACOWSKI, MD-PhD
Organizational Affiliation
Centre d'investigation clinique CIC1406
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre d'investigation clinique CIC1406
City
GRENOBLE cedex9
ZIP/Postal Code
38043
Country
France

12. IPD Sharing Statement

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Hot Flashes and Omega 3

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