Efficacy of a Dietary Supplement (Aqualief®) in Xerostomic Patients (Aqualief)

Effetti Sulla Salivazione a Seguito Della Somministrazione di un Integratore Alimentare (Aqualief®) a Base di Carnosina ed Hibiscus Nei Soggetti Xerostomici: Studio Multicentrico, Randomizzato, in Doppio Cieco, Controllato Verso Placebo

Xerostomia is defined as the subjective complaint of dry mouth. Symptoms of dry mouth may range from mild oral discomfort to significant oral disease that can compromise patients' health, dietary intake and quality of life. Xerostomia is accompanied by numerous signs and symptoms mainly in the mucous membranes, lips, tongue, salivary glands and teeth.

This study was designed to verify efficacy and safety of a novel dietary supplement (Aqualief),designed with the aim of stabilizing the saliva flux and pH at a neutral level and to improve the acid buffering capacity of saliva.

Study Overview

• Status: Completed
• Conditions: Quality of Life; pH; Saliva; Xerostomia Due to Hyposecretion of Salivary Gland
• Intervention / Treatment: Dietary supplement: Aqualief; Dietary supplement: Placebo

Detailed Description

Sixty patients with xerostomia (grade 1-2 according to RTOG/EORTC) from different etiologies were recruited at the Clinica Odontoiatrica dell'Università degli studi dell'Insubria (Varese, Italy). Exclusion criteria were subjects under treatment using drugs to treat hyposalivation (e.g. pilocarpine) and xerostomia grade ≥ 3. Patients with severe hyposalivation were excluded (saliva flow rate at baseline <0.1 ml min-1) due to their inability to dissolve the tablet formulation.

Written informed consent was received from all patients before study initiation. The study was conducted in accordance with the principles laid out by the Declaration of Helsinki 1964 and its subsequent amendments and with the International Committee on Harmonization Guidelines for Good Clinical Practice and in compliance with local ethical and legal requirements. The study was approved by the ethics committee at the participating site.

The study was a prospective, randomized, double-blind, placebo-controlled trial undertaken at the Clinica Odontoiatrica dell'Università degli Studi dell'Insubria (Varese, Italy). Eligible patients who had developed xerostomia RTOG/EORTC grade 1-2 were randomized in a 1:1 ratio, with one group receiving three Aqualief tablets (after meals: breakfast, lunch, dinner) daily for 6 days. The second group received a placebo tablet given with the same regimen. The primary objective of the study was to assess the safety and efficacy of Aqualief in stabilizing the saliva pH at a neutral level compared with placebo. The secondary objective was to determine whether Aqualief induced an increase of unstimulated or stimulated saliva and in ameliorating the symptoms related to oral dryness.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Varese, Italy, 21100
    • Università degli Studi dell'Insubria

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects of both sex
• Age ≥ a 18 years
• Able to understand and sign the Informed Consent, and fill in the patient's diary
• Subjects suffering from Xerosotmia Grade 1-2 (according to RTOG/EORTC scale)
• Sjögren Sindrome
• Lambert-Eaton Sindrome
• Diabetes mellitus and low metabolic control
• Anxiety
• Alcool abuse
• Salivary glands trauma
• Radio and Chemotherapy for head & neck cancer
• Methamphetamine, cannabis, heroin abuse
• Xerostomia caused by (single and concomitant, i.e. Anti-depressive and anxyolitic drugs; Antihistaminic drugs; Decongestive drugs; Antihypertensive drugs; Muscle relaxants; Urinary incontinence drugs; Drugs for Parkinson treatment)
• Subjects affected by paradental pathology diagnosed according to AAOP criteria, PSR 2-3

Exclusion Criteria:

• Contraindication and/or Hypersensitivity to product's components, and in particular carnosine and Hibiscus
• Subjects that are under treatment with products or drugs ( ie pilocarpin) for hypofunctionality of salivary glands
• Subjects with total ablation of salivary glands caused by chemo or radiotherapy
• Use of experimental drugs during 30 days before the enrolment or during the study
• Conditions that can interfere with the study
• Xerostomia grade 3 or higher

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aqualief® tablets; 400 mg mucoadhesive tablets; three times per day just	Dietary supplement: Aqualief; Three tablets/day
Placebo Comparator: Placebo tablets; 400 mg mucoadhesive placebo tablets, three times per day just	Dietary supplement: Placebo; Three tablets/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of Aqualief on salivation	Changes in saliva production is measured (ml)	Change from baseline to 6 days of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of Aqualief	Incidence of Treatment-Emergent Adverse Events	Occurrence of Adverse Events over the 6 days of treatment
Effect of Aqualief on dry mouth symptoms	Evaluate the effect of treatments dry mouth symptoms trough Dry Mouth Questionnaire (Thomson Questionnaire)	Change from baseline to 6 days of treatment
Effect of Aqualief on the pH of saliva	Changes of saliva pH is measured	Change from baseline to 6 days of treatment

Collaborators and Investigators

• Sponsor: Università degli Studi dell'Insubria
• Investigators: Principal Investigator: Luca Levrini, Prfo. MD., Università degli Studi dell'Insubria

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2016
• Primary Completion (Actual): October 31, 2017
• Study Completion (Actual): December 15, 2017

Study Registration Dates

• First Submitted: July 4, 2018
• First Submitted That Met QC Criteria: July 26, 2018
• First Posted (Actual): August 2, 2018

Study Record Updates

• Last Update Posted (Actual): August 2, 2018
• Last Update Submitted That Met QC Criteria: July 26, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Carnosine; xerostomia; pH; karkadé; Aqualief; Mucoadhesive
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Salivary Gland Diseases; Xerostomia
• Other Study ID Numbers: Prot.49 May 31st, 2016

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No