An interventional study of Chios mastic beverage and Placebo beverage in Dyspepsia, sponsored by Harokopio University. Recruiting at 1 site in Greece. Open to participants aged 30 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-09-15.
Sponsored by Harokopio University · Not applicable, Interventional, and Treatment
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.
The term "dyspepsia" encompasses a wide range of upper gastrointestinal symptoms, including early satiety, abdominal pain, flatulence, bloating, postprandial fullness or discomfort, nausea, vomiting, and heartburn. These symptoms are common in several gastrointestinal diseases and affect up to 40% of the population worldwide. Dyspepsia leads to reduced quality of life, functionality, and productivity, and has a significant detrimental impact on healthcare systems due to repeated patient visits to healthcare professionals and unnecessary prescription and use of medications.
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.
372 studies on the registry are indexed under Dyspepsia; 67 are open to participants now.
This study's planned enrollment of 60 is below the median of 89 across 302 interventional studies indexed under Dyspepsia.
Browse Dyspepsia studies →Harokopio University is the lead sponsor of 66 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
This arm will consume 600 mL of a standard sparkling beverage per day for a 3-month period.
Behavioral: Placebo 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.
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.
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.
Time frame: 0 (baseline) and 12 weeks
Change in quality of life
Quality of life will be assessed through the short-form 36-item health survey (SF-36) questionnaire. SF-36 includes 2 generic scales, i.e. the Physical Component Summary and the Mental Component Summary, both ranging from 0 to 100, with 0 representing the worst possible state of health and 100 representing the optimal state of health.
Time frame: 0 (baseline) and 12 weeks
Change in quality of life
Quality of life will be assessed through the short-form 10-item Nepean Dyspepsia Index (SF-NDI) questionnaire. SF-NDI includes 5 sub-scales, i.e. tension, interference with daily activities, eating/drinking, knowledge/control and work/study, each ranging from 2 to 10, with 2 representing the highest quality of life and 10 representing the lowest quality of life.
Time frame: 0 (baseline) and 12 weeks
Change in high-sensitivity C-reactive protein
High-sensitivity C-reactive protein (mg/L) will be measured in blood samples by nephelometry.
Time frame: 0 (baseline) and 12 weeks
Plan to share: Yes — Deidentified individual participant data will be shared to investigators for the purpose of data meta-analysis, provided that the proposed use of the data has been approved by the Study Principal Investigator. Proposals should be directed to garn@hua.gr.
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