Clinical trial NCT06864520: Evaluation of the Beneficial Effects of a Product Containing Γ-aminobutyric Acid (GABA) on Climacteric Syndrome Disorders
Official title: Valutazione Degli Effetti Benefici Di Un Prodotto Contenente Acido Γ-ammino Butirrico (GABA) Sui Disturbi Della Sindrome Climaterica CLIMATERICA
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Climacteric Symptoms
Hot Flashes
Lead sponsor: Ospedale Policlinico San Martino
Sponsor class: OTHER
First posted: 2025-03-07
Enrollment: 112
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed description: This study aims to evaluate the effectiveness of a commercial supplement to alleviate symptoms associated with menopause such as hot flashes, sleep disturbances, and mood swings.

Participants will be required to come to the clinic for a few visits:

* First visit in which the nature of the study will be explained, the intensity of symptoms will be assessed (using the Greene questionnaire), and the inclusion and exclusion criteria for participation in the study will be assessed. If the participant is eligible for the study, they will be asked to fill out a diary for the next 7 days in which to indicate the daily number and intensity of hot flashes;
* Second visit in which the hot flash diary will be collected and the following questionnaires will be submitted: Greene Scale to determine climacteric symptoms; STAI-Y1 to determine state anxiety (20 questions); SDS to determine the presence of depression (20 questions); PSQI to determine the quality of sleep (9 questions); MenQoL, Quality of life (29 questions). At this visit, a new diary will be provided, in which the number and intensity of hot flashes during the last 7 days before the next visit must be reported, and the product to be taken for the following month will be provided; neither the participant nor the investigator are aware of the product provided: study product or placebo;
* Third visit, in which the hot flash diary and the product package delivered at the previous visit will be collected. The participant will have to fill in all the questionnaires completed at the previous visit and will also be asked about the degree of satisfaction with the first 30 days of treatment. At this visit, a new diary will be provided, in which the number and intensity of hot flashes during the last 7 days before the next visit must be reported, and the product to be taken for the following two months will be provided;
* Fourth visit, in which the hot flash diary and the product package delivered at the previous visit will be collected. The participant will have to fill out all the questionnaires completed at the previous visit and will also be asked about the degree of satisfaction with the treatment.

Eligibility criteria: Inclusion Criteria:

* Physiological or iatrogenic menopause (amenorrhea for at least 12 months or for 6 months with FSH ≥40 IU/L)
* Greene Index value ≥ 15

Exclusion Criteria:

* Patients who do not consent to the study
* Patients who have used hormone replacement therapy in the last 3 months
* Patients who have used phytotherapeutics in the last 3 months
* Patients who have used acupuncture in the last 3 months
* Uncompensated hyper or hypothyroidism
* Acute phase of endocrine pathologies
* Patients with major psychiatric disorders
* Addiction to opioids or alcohol
* Glaucoma
* Active liver disease
* Use of antidepressants, benzodiazepines or any neuroactive drug
* Known allergy to the components of the treatment being studied

Primary outcomes:
measure: Change of the Greene Climacteric Scale Score
timeFrame: From enrollment to the end of treatment at 12 weeks
Secondary outcomes:
measure: Assessment of anxiety with the State-Trait Anxiety Inventory-Y1 (STAI-Y1) questionnaire
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Assessment of sleep quality with the Pittsburgh Sleep Quality Index (PSQI) questionnaire
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Reduction in the number and intensity of hot flashes, assessed with a daily diary 7 days before follow up
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Assessment of quality of life with the Menopause-specific Quality of Life (MenQoL) questionnaire
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Comparison of the efficacy of two dosages
timeFrame: From enrollment to the end of treatment at 12 weeks
Other outcomes:
Locations:
city: Genova
country: Italy
facility: Ospedale San Martino
state: Italia
Study officials:
affiliation: Clinica Ostetrica e Ginecologica, IRCCS-Ospedale San Martino di Genova
name: Angelo Cagnacci, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: