A Study of Chios Mastic Water in Dyspepsia
ConditionDyspepsia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-60
SponsorHarokopio University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 30-60 years old.
Body mass index of 20-35 kg/m2.
Presence of dyspepsia.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Chios mastic beverage
BehavioralParticipants 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
BehavioralParticipants 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupPlacebo comparator 1 intervention
Trial outcomes
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.
Time frame
0 (baseline) and 12 weeksSecondary outcomes
1
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 weeks2
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 weeks3
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 weeksSponsors and contacts
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Source ClinicalTrials.gov