A Study of Chios Mastic Water in Irritable Bowel Syndrome

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

Interventions

BEHAVIORAL

Chios mastic water

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.

BEHAVIORAL

Placebo water

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.

BEHAVIORAL

Chios mastic fruit juice

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.

BEHAVIORAL

Placebo fruit juice

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.

Sponsors & Collaborators

• Harokopio University

  collaborator OTHER

• Rutgers, The State University of New Jersey

  lead OTHER

Principal Investigators

• Labros Sidossis, PhD · Department of Kinesiology and Health, School of Arts and Sciences, Rutgers University

• Michael Georgoulis, PhD · Department of Nutrition and Dietetics, School of Health Sciences and Education, Harokopio University

• Alexandra Karachaliou, MSc · Department of Nutrition and Dietetics, School of Health Sciences and Education, Harokopio University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-09-12

Primary Completion

2022-05-16

Completion

2022-05-16

Countries

• Greece

Study Locations