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

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

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

Study Overview

• Status: Recruiting
• Conditions: Hot Flashes; Climacteric Symptoms
• Intervention / Treatment: Dietary supplement: GAMMA-AMINOBUTYRIC ACID - GABA; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 112
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ANGELO CAGNACCI; Phone Number: +39-010-3537728; Email: angelo.cagnacci@unige.it

Study Locations

• Italy
  • Italia
    • Genova, Italia, Italy, 16132
      • Recruiting
      • Ospedale San Martino
      • Contact: ANGELO CAGNACCI; Phone Number: +39 - 010 - 3537728; Email: angelo.cagnacci@unige.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A1 with 3 capsules; Tablets containing 250mg of γ-aminobutyric acid (GABA) and 50mg of Melissa extract, to be taken one at lunch and two before bedtime for 12 weeks	Dietary supplement: GAMMA-AMINOBUTYRIC ACID - GABA; Food supplement based on GABA and Melissa extract
Placebo Comparator: Group A2 with 3 capsules; Tablets containing microcrystalline cellulose, rice bran, bitter cocoa powder, to be taken one at lunch and two before bedtime for 12 weeks	Other: Placebo; Placebo based on microcrystalline cellulose, rice bran, bitter cocoa powder
Active Comparator: Group B1 with 2 capsules; Tablets containing 250mg of γ-aminobutyric acid (GABA) and 50mg of Melissa extract, to be taken one at lunch and one before bedtime for 12 weeks	Dietary supplement: GAMMA-AMINOBUTYRIC ACID - GABA; Food supplement based on GABA and Melissa extract
Placebo Comparator: Group B2 with 2 capsules; Tablets containing microcrystalline cellulose, rice bran, bitter cocoa powder, to be taken one at lunch and one before bedtime for 12 weeks	Other: Placebo; Placebo based on microcrystalline cellulose, rice bran, bitter cocoa powder

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From enrollment to the end of treatment at 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From enrollment to the end of treatment at 12 weeks
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	From enrollment to the end of treatment at 12 weeks
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).	From enrollment to the end of treatment at 12 weeks
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	From enrollment to the end of treatment at 12 weeks
Comparison of the efficacy of two dosages		From enrollment to the end of treatment at 12 weeks

Collaborators and Investigators

• Sponsor: Ospedale Policlinico San Martino
• Investigators: Principal Investigator: Angelo Cagnacci, MD, PhD, Clinica Ostetrica e Ginecologica, IRCCS-Ospedale San Martino di Genova

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2023
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: February 24, 2025
• First Submitted That Met QC Criteria: March 4, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 4, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hot Flashes; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; GABA Agents; gamma-Aminobutyric Acid
• Other Study ID Numbers: 12420

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No