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RECRUITING
NCT06864520
NA

Evaluation of the Beneficial Effects of a Product Containing Γ-aminobutyric Acid (GABA) on Climacteric Syndrome Disorders

Sponsor: Ospedale Policlinico San Martino

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn if the food supplement based on GABA works to treat climateric symptoms. It will also learn about the safety of supplement based on GABA. The main question aims to answer: * Does food supplement based on GABA lower the climateric symptoms, such as hot flashes, sleep, disturbances, mood swings? * The supplement that will be administered is commonly available on the market and can be used without particular precautions. No important side effects are reported. Researchers will compare supplement based on GABA to a placebo (a look-alike substance that contains no active ingredients) to see if supplement based on GABA works to treat climateric symptoms. Participants will: * Take supplement based on GABA or a placebo every day for 3 months * Visit the clinic on day 7, 37 and 97 after enrolment for checkups and tests * Keep a diary of number and intensity of hot flashes * To fill scales evaluating sleep quality, anxiety, depression and quality of life

Official title: Valutazione Degli Effetti Benefici Di Un Prodotto Contenente Acido Γ-ammino Butirrico (GABA) Sui Disturbi Della Sindrome Climaterica CLIMATERICA

Key Details

Gender

FEMALE

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

112

Start Date

2023-10-25

Completion Date

2025-12

Last Updated

2025-03-07

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

GAMMA-AMINOBUTYRIC ACID - GABA

Food supplement based on GABA and Melissa extract

OTHER

Placebo

Placebo based on microcrystalline cellulose, rice bran, bitter cocoa powder

Locations (1)

Ospedale San Martino

Genova, Italia, Italy