MedTrace Logo

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

NCT06864520 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2025-03-07

No results posted yet for this study

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

Conditions

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

Sponsors & Collaborators

  • Ospedale Policlinico San Martino

    lead OTHER

Principal Investigators

  • Angelo Cagnacci, MD, PhD · Clinica Ostetrica e Ginecologica, IRCCS-Ospedale San Martino di Genova

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-25
Primary Completion
2025-11-30
Completion
2025-12-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06864520 on ClinicalTrials.gov