The Effect of Citrus Extract on Gastrointestinal Health

The Effect of Citrus Extract Administration on Gastrointestinal Health

This randomized, parallel, double-blind, placebo-controlled trial aims to determine the effects of daily administration of citrus extract over a period of 8 weeks on gastrointestinal health in patients with irritable bowel syndrome.

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Citrus extract

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 2

Contacts and Locations

Study Locations

• Netherlands
  • Limburg
    • Maastricht, Limburg, Netherlands, 6229 HX
      • Maastricht University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with IBS
• Calprotectin levels 15-150 µg/g feces
• Age 18-70 years
• BMI < 35 kg/m2

Exclusion Criteria:

• Comorbidities that may influence gut microbiota composition or which might limit participation in or completion of the study protocol (to be decided by the principle investigator)
• Abdominal surgery interfering with gastrointestinal function (to be decided by the principle investigator)
• Use of immunosuppressive drugs within 3 months before study period
• Use of other medication interfering with endpoints
• Changes in medication that may significantly affect the study outcome according to the investigator's judgment within 1 month prior to the study
• Changes in clinical activity scores within 3 weeks prior to the study
• Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator) in the 180 days prior to the study
• Use of dietary supplements containing antioxidants, minerals and vitamins
• Excessive intake of foods with a high polyphenol concentration
• Use of antibiotics within 3 months prior to the start of study
• Use of pre-or probiotics within 1 month prior to the study
• Use of oral corticosteroids within 1 month prior to the study
• Blood donation within 1 month prior to the study
• Known pregnancy or lactation.
• Excessive drinking (>20 alcoholic consumptions per week)
• History of any side effects towards the intake of flavonoids or citrus fruits

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Maltodextrin	Dietary supplement: Placebo; Maltodextrin
Experimental: Citrus extract	Dietary supplement: Citrus extract; Citrus extract

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The effect on intestinal inflammation, measured by fecal calprotectin levels.	The primary objective is to assess the effect of 500 mg citrus extract on intestinal flammation after 8 weeks of administration, by measuring fecal calprotectin in IBS patients with moderately increased fecal calprotectin levels.	8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
The effect on microbial metabolic activity, measured by fecal short chain fatty acids (SCFA).	8 weeks
The effect on fecal microbiota composition, assessed by next generation sequencing.	8 weeks
The effect on fecal microbiota functional capacity, assessed by next generation sequencing.	8 weeks
The effect on the systemic immune response, measured by cytokine production capacity of stimulated whole blood	8 weeks
The effect on disease symptoms, measured by patient reported outcomes (GSRS).	8 weeks
The effect on disease symptoms, measured by patient reported outcomes (symptom diary).	8 weeks
The effect on stool frequency, measured by Bristol Stool Chart.	8 weeks
The effect on stool consistency, measured by Bristol Stool Chart.	8 weeks
The effect on blood markers for oxidative stress, measured by MDA concentration in blood.	8 weeks
The effect on blood markers for antioxidant capacity, measured by blood total antioxidant capacity.	8 weeks

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2017
• Primary Completion (Actual): February 12, 2021
• Study Completion (Actual): February 13, 2021

Study Registration Dates

• First Submitted: June 9, 2017
• First Submitted That Met QC Criteria: July 20, 2017
• First Posted (Actual): July 21, 2017

Study Record Updates

• Last Update Posted (Actual): February 21, 2021
• Last Update Submitted That Met QC Criteria: February 18, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Irritable Bowel Syndrome
• Other Study ID Numbers: 173003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No