A Study of Chios Mastic Water in Irritable Bowel Syndrome

NCT04893499 | Completed

• 1 other identifier: Γ-1038/12-3-2021
• Study Type: interventional
• Target: 55
• 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 irritable bowel syndrome. This will be a 3-month randomized double-blind controlled clinical trial in adult patients with irritable bowel syndrome under standard medication. Participants will be blindly randomized to a low-dose mastic group, which will receive a carbonated water enriched with Chios mastic water (0.06%), a high-dose mastic group, which will receive a carbonated fruit juice enriched with Chios mastic water (0.55%), or one of the two control groups, which will receive an identical placebo water/fruit juice with no active ingredients. Participants will be evaluated in terms of anthropometric indices, lifestyle habits, severity of IBS-related gastrointestinal symptoms, quality of life, as well as biochemical, inflammatory and oxidative stress markers, both pre- and post-intervention.

Conditions

Irritable Bowel Syndrome

Keywords

Pistacia Lentiscus var. Chia; Chios mastic; mastiha; irritable bowel syndrome; dyspepsia; constipation; diarrhea; abdominal pain; bloating; gastrointestinal health

Outcome Measures

Primary Outcomes (2)

• Change in IBS symptoms severity assessed through the IBS Symptom Severity Scale (IBS-SSS)

  The score ranges from 0 to 500, with higher values indicating more severe symptoms.

  0 (baseline) and 12 weeks

• Change in quality of life assessed through the IBS Quality of Life questionnaire (IBS-QOL)

  Τhe score ranges from 34 to 170 with higher values indicating lower quality of life.

  0 (baseline) and 12 weeks

Secondary Outcomes (4)

• Change in high-sensitivity C-reactive protein

  0 (baseline) and 12 weeks

• Change in high-sensitivity interleukin-6 levels

  0 (baseline) and 12 weeks

• Change in malondialdehyde

  0 (baseline) and 12 weeks

• Change in total serum antioxidant capacity

  0 (baseline) and 12 weeks

Study Arms (4)

Low-dose mastic group

EXPERIMENTAL

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

Behavioral: Chios mastic water

Low-dose control group

PLACEBO COMPARATOR

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

Behavioral: Placebo water

High-dose mastic group

EXPERIMENTAL

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

Behavioral: Chios mastic fruit juice

High-dose control group

PLACEBO COMPARATOR

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

Behavioral: Placebo fruit juice

Interventions

Chios mastic water BEHAVIORAL

Participants randomized to this intervention arm will be provided with a sparkling water enriched with the natural mastic aqueous extract (0.06%), 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 keep the use of medication and dietary supplements stable and preserve their typical lifestyle habits throughout the study.

Also known as: Mastiqua

Low-dose mastic group

Placebo water BEHAVIORAL

Participants randomized to this intervention arm will be provided with a standard sparkling water and will be asked to consume it daily (3 bottles of 200 mL each) for 3 months. Participants will also be instructed to keep the use of medication and dietary supplements stable and preserve their typical lifestyle habits throughout the study.

Low-dose control group

Chios mastic fruit juice BEHAVIORAL

Participants randomized to this intervention arm will be provided with a sparkling fruit juice enriched with the natural mastic aqueous extract (0.55%), 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 keep the use of medication and dietary supplements stable and preserve their typical lifestyle habits throughout the study.

Also known as: Mastiqua lemon

High-dose mastic group

Placebo fruit juice BEHAVIORAL

Participants randomized to this intervention arm will be provided with a standard sparkling fruit juice and will be asked to consume it daily (3 bottles of 200 mL each) for 3 months. Participants will also be instructed to keep the use of medication and dietary supplements stable and preserve their typical lifestyle habits throughout the study.

High-dose control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65 years old
• Body mass index 18.5-35 kg/m2
• IBS diagnosis

You may not qualify if:

• Presence of other gastrointestinal disorders, such as gastritis, peptic ulcer, functional dyspepsia, celiac disease and inflammatory bowel disease
• Presence of other serious comorbidities, such as diabetes mellitus, active cancer, cardiovascular disease, pulmonary, kidney, liver, chronic inflammatory, autoimmune or psychiatric diseases
• Recent (within 6 months) surgery or hospitalization
• Habitual excessive alcohol consumption (\> 210 or \> 140 gr of alcohol per week for men and women, respectively)
• Currently on a weight-loss diet or recent change (within 6 months) in lifestyle habits
• Pregnancy or breast feeding (for women)

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• Harokopio University: collaborator

Study Sites (1)

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

Kallithea, Attica, 17676, Greece

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome; Dyspepsia; Constipation; Diarrhea; Abdominal Pain

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations

Study Officials

• Labros Sidossis, PhD

  Department of Kinesiology and Health, School of Arts and Sciences, Rutgers University

  PRINCIPAL INVESTIGATOR

• Michael Georgoulis, PhD

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

  STUDY CHAIR

• Alexandra Karachaliou, MSc

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

  STUDY CHAIR

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: Professor in Nutrition - Dietetics

Study Record Dates

• First Submitted: May 14, 2021
• First Posted: May 19, 2021
• Study Start: September 12, 2021
• Primary Completion: May 16, 2022
• Study Completion: May 16, 2022
• Last Updated: September 29, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share

Locations

GR (1)