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Evaluation of the Beneficial Effects of a Product Containing Γ-aminobutyric Acid (GABA) on Climacteric Syndrome Disorders
Sponsor: Ospedale Policlinico San Martino
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
Conditions
Interventions
GAMMA-AMINOBUTYRIC ACID - GABA
Food supplement based on GABA and Melissa extract
Placebo
Placebo based on microcrystalline cellulose, rice bran, bitter cocoa powder
Locations (1)
Ospedale San Martino
Genova, Italia, Italy