Alpha-lipoic Acid Combined With B Vitamins Shows Promise for Treating Restless Legs Syndrome

Uriach Consumer Healthcare20 enrolled

Overview

Investigating Tiobec® 400's efficacy in alleviating Restless Legs Syndrome symptoms sheds light on promising therapeutic avenues.

Restless legs syndrome, also known as Willis-Ekbom disease, is a neurological disorder characterised by uncomfortable sensations in the legs and an urge to move them. In Spain, its prevalence range is estimated to be between 11.6% - 19.5% in adults, but it is difficult to know due to underdiagnosis. Alpha-lipoic acid (ALA) and B vitamins have emerged as potential treatments due to their roles in reducing oxidative stress and associated vitamin deficiencies. The Tiobec® 400 (T400) supplement combines ALA, B vitamins, E, and C, and its efficacy and safety in alleviating RLS symptoms, along with its impact on anthropometric measures, are under investigation. This study aims to explore therapeutic options for managing RLS, with promising results.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Restless Legs Syndrome

Interventions

Alpha-lipoic acid combined with B vitaminsDIETARY_SUPPLEMENT

The investigational product utilized in this research, Tiobec® 400 is a dietary supplement enriched with ALA, B vitamins, and vitamins E and C. T400 is designed to mitigate oxidative stress and support the optimal functioning of the nervous system

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participants must be a minimum of 18 years of age. * They must have a primary diagnosis of RLS without prior therapeutic interventions for the ailment. * They need to provide explicit consent via an informed consent document. Exclusion Criteria: * Patients diagnosed with pathologies other than RLS that affect sleep quality. * Those with persistent renal diseases or any other chronic, severe medical condition.

Locations (1)

Medical Center Teknon

Barcelona, Spain

Outcomes

Primary Outcomes

Measure the subjective RLS symptoms of the participants through the IRLSSG rating scale (IRLS)

This scale contains 10 items, rated from 0 to 4, according to the severity reported by the patient (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe.). The cumulative scores are categorized as mild (1-10), moderate (11-20), severe (21-30), and very severe (31-40).

Time frame: 6 months

Secondary Outcomes

Anthropometric parameters of the patients.

Weight (kg).

Time frame: 6 Months

Patients' body measurements

Body mass index (BMI) (kg/m²).

Time frame: 6 Months

Measurements of patient anatomy

Total fat mass (kg).

Time frame: 6 Months

Patients' body characteristics.

Visceral fat mass (kg).

Time frame: 6 Months

Measurements of patient anatomy.

Muscle mass (kg).

Time frame: 6 Months

Data from ClinicalTrials.gov

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