Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
60 participants
INTERVENTIONAL
2025-07-10
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Mastiha or Mastiha Water in Functional Dyspepsia
NCT05687539
Zypan Functional Dyspepsia
NCT06320379
Efficacy and Safety of Hizikia Fusiformis Extract in Subjects Showing Erosive Gastritis
NCT01689701
Carbon-13 (13C)-Spirulina Platensis Gastric Emptying Breath Test (GEBT)
NCT01248221
Mast Cells in Acid-induced Intestinal Permeability
NCT02664051
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Several natural plant products have emerged as potential therapeutic agents, due to their high content of bioactive compounds that can inhibit the manifestation of pathophysiological processes. Chios mastic is the resin of the mastic tree (Pistacia Lentiscus var. Chia), produced exclusively in the southern part of the Greek island of Chios. References about the medical use of Chios mastic from Greek populations for the treatment of gastrointestinal disorders or as a cosmetic agent can be found in ancient texts. Nowadays, this versatile resin has been rediscovered, not only as a traditional remedy and aromatic agent, but also as a potent phytotherapeutic product with strong anti-inflammatory and anti-oxidant properties. In 2015, Chios mastic was recognized as an herbal medicinal product by the European Medicines Agency (EMA), with two therapeutic indications: mild dyspeptic disorders and skin inflammation/healing of minor wounds (EMA/HMPC/46758/2015).
Over the last years, Chios mastic has been widely used in medicinal products and food supplements, and has become the object of intense study in the fields of Nutrition and Pharmacotechnology with the aim of investigating its beneficial effects on pathological conditions mainly located in the gastrointestinal system. The few available randomized controlled clinical trials in the field have mainly investigated the effect of supplemental administration of Chios mastic in patients with inflammatory bowel diseases (Crohn's disease), irritable bowel syndrome and functional dyspepsia, highlighting its benefits in reducing the severity of gastrointestinal symptoms and improving quality of life. However, no study to date has focused on the integration of a food/beverage enriched with Chios mastic into the usual diet of individuals with gastrointestinal disorders and on investigating its potential beneficial effects on gastrointestinal health, symptoms and health-related quality of life.
Given the beneficial effect of Chios mastic on gastrointestinal health, the aim of the present study is to investigate the effect of beverages, without added sugars or artificial sweeteners and enriched with natural aqueous extract of Chios mastic (mastic water), in individuals with dyspepsia. The research hypothesis is that the incorporation of beverages enriched with mastic water into the diet of individuals with dyspepsia will lead to an improvement in the severity of gastrointestinal symptoms and associated quality of life, highlighting them as functional substitutes for conventional beverages.
The study will be a 3-month parallel, randomized (allocation ratio 1:1), controlled, double-blind clinical trial in a sample of 60 adult patients with dyspepsia. Participants will be excluded on the basis of the presence of other chronic gastrointestinal diseases, the presence of other serious comorbidities, or recent significant changes in lifestyle habits. Participants will be randomized to an intervention group (IG) or a control group (CG). The IG will be provided with 600 mL of a sparkling beverage (Mastiqua lemon lime) containing the natural mastic aqueous extract (0.2%) to be consumed daily (3 bottles of 200 mL each). The CG will be provided with the same quantity of a placebo sparkling beverage, which will be identical in appearance and organoleptic characteristics, including the characteristic Chios mastic aroma. Randomization will be performed by an investigator with no clinical involvement, while all patients and study team members will be blinded to patient allocation in study groups. All enrolled patients will be asked to maintain their usual dietary and physical activity practices and keep their standard medical treatment stable throughout the study. The study physician will systematically record potential side-effects and will be in charge of terminating the intervention if needed.
At baseline and at the end of the 3-month study, participants will be evaluated in terms of anthropometric indices (body weight, height and waist circumference), body composition, lifestyle (diet and physical activity) habits, the presence and severity of dyspepsia-related gastrointestinal symptoms and quality of life. In addition, 12-h fasting blood samples will be collected and various biochemical markers (e.g., glucose metabolism indices, lipidemic profile, liver enzymes and inflammatory markers) will be measured in serum/plasma samples both pre- and post-intervention.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervention group
This arm will consume 600 mL of a sparkling beverage enriched with Chios mastic per day for a 3-month period.
Chios mastic beverage
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.
Control group
This arm will consume 600 mL of a standard sparkling beverage per day for a 3-month period.
Placebo beverage
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Chios mastic beverage
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.
Placebo beverage
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Body mass index of 20-35 kg/m2.
* Presence of dyspepsia.
Exclusion Criteria
* 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)
30 Years
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Harokopio University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
GIANNIS ARNAOUTIS
Assistant Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Giannis Arnaoutis, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Nutrition and Dietetics, School of Health Sciences and Education, Harokopio University of Athens
Labros Sidossis, PhD
Role: STUDY_DIRECTOR
Department of Nutrition and Dietetics, School of Health Sciences and Education, Harokopio University of Athens
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Nutrition and Dietetics, School of Health Sciences and Education, Harokopio University of Athens
Kallithea, Attica, Greece
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
470/05-02-2025
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.