Clinical trial NCT03801057: Marine Protein Hydrolysate as Dietary Supplement in Irritable Bowel Syndrome
Official title: The Effect of a Marine Protein Hydrolysate Supplement on Inflammatory Markers, Microbiota Composition and Symptoms in Patients With Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Keywords: Dietary Supplements
Fish Proteins
Protein Hydrolysates
Lead sponsor: Helse Møre og Romsdal HF
Sponsor class: OTHER_GOV
Collaborators: name: Haukeland University Hospital
name: University of Bergen
First posted: 2019-01-11
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A parallel group randomized, controlled clinical trial for six weeks
Primary purpose: TREATMENT

Brief summary: The use of natural bioactive products for prevention and treatment of a wide spectrum of conditions, including gastrointestinal disorders and conditions is well known. Based on current evidences, the scientific validity of such products is limited. However, there is sufficient preliminary data to indicate that bioactive compounds may be novel for potentially clinical use, thus further clinical trials investigating effect are needed. This trial is meant to evaluate the effect of an marine protein hydrolysate (MPH) supplement on composition of microbiota, inflammatory markers and symptom severity in people diagnosed with irritable bowel syndrome.

Detailed description: Previous studies performed in rodents have found that hydrolyzed proteins from fish alters the lipid and cholesterol metabolism, reduce plasma cholesterol and triglyceride levels and alters the fatty acid composition in liver and adipose tissue. Previous studies in humans have found marine peptides to have both antihypertensive and antioxidant effects. It is also suggested that fish protein hydrolysates may have an immunomodulating effect with beneficial properties in the intestine, and may prevent NSAID-induced injuries, change permeability in the gut and possibly prevent injurious conditions in the gut.

The evidence and knowledge are limited on the interaction between diet, gut microbiota and the influence of specific nutrients, as well as the impact of different sources of proteins on inflammation markers, gut microbiota and symptom severity in patients with irritable bowel syndrome (IBS). Different dietary sources of protein affect the diversity and composition of the human gut microbiota in different degree, demonstrated by a distinct gut bacteria profile observed between omnivores and vegetarians.The specific effect of marine peptides on human gut microbiota composition is as far as the investigators know, previously not investigated. Interestingly, novel results indicate that the presence of fish proteins in the diet have impact on both composition and activity of the gut microbiome, influencing the human microbiota composition.

The many benefits of expanding the utilization of marine products, the previous assumed beneficial intestinal effect and the increased interest in gut health and microbiota, as well as a great need for novel dietary treatment strategies for patients with irritable bowel syndrome (IBS) make this study warrant.

Aim with this trial is to evaluate the effect of an marine protein hydrolysate (MPH) supplement on composition of microbiota, inflammatory markers and symptom severity in human subjects diagnosed with IBS.

Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Body mass index (BMI) 18-30 kg/m2
* Irritable Bowel Syndrome (IBS) diagnosis according to Rome IV criteria

Exclusion Criteria:

* Suspected allergies against fish or shellfish
* Low or unstable blood pressure
* Diabetes mellitus pharmacologically treated
* Chronic diseases or therapies that are likely to interfere with the evaluation of study results such as known inflammation
* Acute infections (may be reconsidered for inclusion at a later time)
* Substance misuse
* Inability or unwillingness to comply with the requirements of study procedures
* Individuals in the middle of testing different dietary strategies for the treatment of IBS (such as the low-FODMAP diet) and/or not willing to/able to maintain a stable diet throughout the study period
* Use of pro- or prebiotic supplements
* Use of antibiotic treatment for the last 4 weeks
* Immunocompromised patient defined as taking immuno-suppressive medications

Primary outcomes:
measure: IBS-SSS
timeFrame: Before (baseline) and after intervention (6 weeks later).
Secondary outcomes:
measure: SF-NDI_HRQOL
timeFrame: Before (baseline) and after intervention (6 weeks later).
measure: Fecal Calprotectin
timeFrame: Before (baseline) and after intervention (6 weeks later).
Other outcomes:
measure: Inflammatory markers in blood
timeFrame: Before (baseline) and after intervention (6 weeks later).
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Ålesund
country: Norway
facility: Ålesund Hospital, Helse Møre og Romsdal HF
Study officials:
affiliation: Helse Møre og Romsdal Hospital Trust
name: Dag Arne Lihaug Hoff, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Dale HF, Jensen C, Hausken T, Valeur J, Hoff DAL, Lied GA. Effects of a Cod Protein Hydrolysate Supplement on Symptoms, Gut Integrity Markers and Fecal Fermentation in Patients with Irritable Bowel Syndrome. Nutrients. 2019 Jul 17;11(7):1635. doi: 10.3390/nu11071635.