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

NCT06864520 | Recruiting

• 1 other identifier: 12420
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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

Conditions

Climacteric Symptoms; Hot Flashes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Assessment of anxiety with the State-Trait Anxiety Inventory-Y1 (STAI-Y1) questionnaire

  From enrollment to the end of treatment at 12 weeks

• Assessment of sleep quality with the Pittsburgh Sleep Quality Index (PSQI) questionnaire

  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

  From enrollment to the end of treatment at 12 weeks

• Assessment of quality of life with the Menopause-specific Quality of Life (MenQoL) questionnaire

  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

Study Arms (4)

Group A1 with 3 capsules

ACTIVE COMPARATOR

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

Group A2 with 3 capsules

PLACEBO COMPARATOR

Tablets containing microcrystalline cellulose, rice bran, bitter cocoa powder, to be taken one at lunch and two before bedtime for 12 weeks

Other: Placebo

Group B1 with 2 capsules

ACTIVE COMPARATOR

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

Group B2 with 2 capsules

PLACEBO COMPARATOR

Tablets containing microcrystalline cellulose, rice bran, bitter cocoa powder, to be taken one at lunch and one before bedtime for 12 weeks

Other: Placebo

Interventions

GAMMA-AMINOBUTYRIC ACID - GABA DIETARY_SUPPLEMENT

Food supplement based on GABA and Melissa extract

Group A1 with 3 capsules; Group B1 with 2 capsules

Placebo OTHER

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

Group A2 with 3 capsules; Group B2 with 2 capsules

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ospedale Policlinico San Martino: lead

Study Sites (1)

Ospedale San Martino

Genova, Italia, 16132, Italy

RECRUITING

MeSH Terms

Conditions

Hot Flashes

Interventions

gamma-Aminobutyric Acid

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Angelo Cagnacci, MD, PhD

  Clinica Ostetrica e Ginecologica, IRCCS-Ospedale San Martino di Genova

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ANGELO CAGNACCI

CONTACT

+39-010-3537728; angelo.cagnacci@unige.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor Obstetric and Gynecology - Director Academic Unit of Obstetrics and Gynecology

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: March 7, 2025
• Study Start: October 25, 2023
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 7, 2025

Record last verified: 2025-02

Locations

IT (1)