Hot Flashes and Omega 3 (BOOM3)

VivaTech

Status: Completed

Conditions: Fatty Acids; Menopause; Hot Flashes

Treatments: Dietary Supplement: omega-3 fatty acids; Dietary Supplement: placebo

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT02062528

DCIC 13 15

Details and patient eligibility

About

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

Enrollment: 136 patients

Sex: Female

Ages: 35+ years old

Volunteers: Accepts 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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136 participants in 2 patient groups, including a placebo group

omega-3 fatty acids

Experimental group

Description:

3 capsules each day during 8 weeks

Treatment:

Dietary Supplement: omega-3 fatty acids

placebo

Placebo Comparator group

Description:

3 capsules each day during 8 weeks

Treatment:

Dietary Supplement: placebo