A Study of Chios Mastic Water in Dyspepsia

NCT06909890 | Recruiting

• 1 other identifier: 470/05-02-2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Chios mastic is a natural product with strong antimicrobial, anti-inflammatory and antioxidant properties, and well-established benefits for dyspeptic disorders. The aim of the present study is to investigate the effectiveness of a natural aqueous extract of Chios mastic (mastic water), a by-product of Chios mastic processing, in the management of dyspepsia. This will be a 3-month randomized double-blind controlled clinical trial in adults with dyspepsia. Participants will be blindly randomized to an intervention group, which will receive 600 mL/d of a carbonated beverage enriched with Chios mastic water (0.2%), or a control group, which will receive 600 mL/d of an identical placebo beverage with no active ingredients. Participants will be evaluated in terms of anthropometric indices, lifestyle habits, severity of dyspepsia-related gastrointestinal symptoms, quality of life, as well as biochemical markers, both pre- and post-intervention.

Conditions

Dyspepsia

Keywords

Pistacia Lentiscus var. Chia; Chios mastic; dyspepsia; gastrointestinal health

Outcome Measures

Primary Outcomes (1)

• Change in dyspepsia symptoms severity

  Dyspepsia symptoms will be assessed through the Patient Assessment of Gastrointestinal Disorders - Dyspepsia Symptom Severity Index (PAGI-SYM). The questionnaire's score ranges from 0 to 100, with higher values indicating more severe symptoms.

  0 (baseline) and 12 weeks

Secondary Outcomes (3)

• Change in quality of life

  0 (baseline) and 12 weeks

• Change in quality of life

  0 (baseline) and 12 weeks

• Change in high-sensitivity C-reactive protein

  0 (baseline) and 12 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

This arm will consume 600 mL of a sparkling beverage enriched with Chios mastic per day for a 3-month period.

Behavioral: Chios mastic beverage

Control group

PLACEBO COMPARATOR

This arm will consume 600 mL of a standard sparkling beverage per day for a 3-month period.

Behavioral: Placebo beverage

Interventions

Chios mastic beverage BEHAVIORAL

Participants of this intervention arm will be provided with a sparkling beverage enriched with the natural mastic aqueous extract (0.2%), a by-product of Chios mastic processing, and will be asked to consume it daily (3 bottles of 200 mL each) for 3 months. Participants will also be instructed to maintain their usual lifestyle practices and medical treatment stable.

Intervention group

Placebo beverage BEHAVIORAL

Participants of this intervention arm will be provided with a placebo sparkling beverage (same organoleptic characteristics with experimental beverage but no active ingredients) and will be asked to consume it daily (3 bottles of 200 mL each) for 3 months. Participants will also be instructed to maintain their usual lifestyle practices and medical treatment stable.

Control group

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 30-60 years old.
• Body mass index of 20-35 kg/m2.
• Presence of dyspepsia.

You may not qualify if:

• Presence of chronic diseases (e.g. diabetes mellitus, cancer, cardiovascular, hepatic, renal, respiratory, chronic inflammatory and psychiatric diseases).
• Presence of other chronic gastrointestinal diseases (e.g. gastroesophageal reflux, inflammatory bowel disease and celiac disease).
• Use of immunosuppressants, anti-inflammatories, antibiotics and corticosteroids.
• Use of dietary supplements or other products with Chios mastic.
• Excessive alcohol consumption (\>210 g and \>140 g of ethanol per week for men and women, respectively).
• Currently on a weight-loss diet or recent (within 6 months) significant change in lifestyle habits.
• Pregnancy or breast feeding (for women)

Sponsors & Collaborators

• Harokopio University: lead

Study Sites (1)

Department of Nutrition and Dietetics, School of Health Sciences and Education, Harokopio University of Athens

Kallithea, Attica, 17676, Greece

RECRUITING

MeSH Terms

Conditions

Dyspepsia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Giannis Arnaoutis, PhD

  Department of Nutrition and Dietetics, School of Health Sciences and Education, Harokopio University of Athens

  PRINCIPAL INVESTIGATOR

• Labros Sidossis, PhD

  Department of Nutrition and Dietetics, School of Health Sciences and Education, Harokopio University of Athens

  STUDY DIRECTOR

Central Study Contacts

Giannis Arnaoutis, PhD

CONTACT

+302109549100; garn@hua.gr

Michael Georgoulis, PhD

CONTACT

+302109549100; mgeor@hua.gr

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: Assistant Professor

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: April 4, 2025
• Study Start: July 10, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

GR (1)