RecruitingNot ApplicableNCT06864520

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

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


Sponsor

Ospedale Policlinico San Martino

Enrollment

112 participants

Start Date

Oct 25, 2023

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Sex: FEMALE

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying GAMMA-AMINOBUTYRIC ACID - GABA and Placebo for people with climacteric symptoms and hot flashes. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTGAMMA-AMINOBUTYRIC ACID - GABA

Food supplement based on GABA and Melissa extract

OTHERPlacebo

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


Locations(1)

Ospedale San Martino

Genova, Italia, Italy

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NCT06864520


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