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
Physiological or iatrogenic menopause (amenorrhea for at least 12 months or for 6 months with FSH ≥40 IU/L)
Greene Index value ≥ 15
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
Parallel
GAMMA-AMINOBUTYRIC ACID - GABA
Dietary supplementFood supplement based on GABA and Melissa extract
Placebo
Other interventionPlacebo based on microcrystalline cellulose, rice bran, bitter cocoa powder
Change of the Greene Climacteric Scale Score
The Greene Scale is a verified measurement tool which provides a brief measure of menopause symptoms. It is composed of 21 items evaluating the bother of climacteric symptoms with a score for each symptom from none (value of 0) to mild (value of 1) to moderate (value of 2) to intense (value of 3). The total score of the ranges from 0 to 63, higher values corresponding to more intense climacteric symptoms. A value equal or greater than 15 indicates the presence of climacteric symptoms
Assessment of anxiety with the State-Trait Anxiety Inventory-Y1 (STAI-Y1) questionnaire
The State-Trait Anxiety Inventory (STAI) is a commonly used measure of state (Y1) of anxiety with 20 items. It can be used to diagnose anxiety and to distinguish it from depressive syndromes. All items are rated on a 4-point scale (with 1 = not at all and 4 = very much) and the total score is between 20 and 80 with a threshold value predictive of anxious symptoms set at 40. Higher scores are positively correlated with higher levels of anxiety
Assessment of sleep quality with the Pittsburgh Sleep Quality Index (PSQI) questionnaire
The Pittsburgh Sleep Quality Index assesses sleep quality and disturbances. The global score ranges between 0 and 21, where higher scores indicate worse sleep quality
Reduction in the number and intensity of hot flashes, assessed with a daily diary 7 days before follow up
Participants report in their daily diary the number and intensity of hot flashes, rating them on a 3-point scale (1 = mild, 2 = moderate, and 3 = severe).
Assessment of quality of life with the Menopause-specific Quality of Life (MenQoL) questionnaire
The MENQOL consists of a total of 29 items in a Likert-scale format. Each item assesses the impact of one of four domains of menopausal symptoms: vasomotor, psychosocial, physical, and sexual. Items pertaining to a specific symptom are rated as present or not present, and if present, how bothersome on a zero (not bothersome) to six (extremely bothersome) scale. The possible score on any item ranges from one to eight, where higher score indicates higher symptoms
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