Marine Protein Hydrolysate as Dietary Supplement in Irritable Bowel Syndrome

NCT ID: NCT03801057

Last Updated: 2019-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-14
• Study Completion Date: 2019-04-21

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.

Conditions

Irritable Bowel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

MPH_active

Daily intake at breakfast of supplementary marine protein hydrolysate (MPH). Random sequence of arms.

Group Type: ACTIVE_COMPARATOR

MPH_active

Intervention Type: DIETARY_SUPPLEMENT

One daily intake at breakfast of supplementary marine protein hydrolysate (MPH), a dosage of 2400 mg, duration 6 weeks. The form is powder, flavored with lemon, and to be mixed with 100 ml water. Random sequence of arms.

MPH_placebo

Daily intake at breakfast of supplementary placebo. Random sequence of arms.

Group Type: PLACEBO_COMPARATOR

MPH_placebo

Intervention Type: DIETARY_SUPPLEMENT

One daily intake at breakfast of supplementary placebo, a dosage of 2400 mg, duration 6 weeks. The form is powder, flavored with lemon, and to be mixed with 100 ml water.

Interventions

MPH_active

One daily intake at breakfast of supplementary marine protein hydrolysate (MPH), a dosage of 2400 mg, duration 6 weeks. The form is powder, flavored with lemon, and to be mixed with 100 ml water. Random sequence of arms.

Intervention Type: DIETARY_SUPPLEMENT

MPH_placebo

One daily intake at breakfast of supplementary placebo, a dosage of 2400 mg, duration 6 weeks. The form is powder, flavored with lemon, and to be mixed with 100 ml water.

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Haukeland University Hospital

OTHER

Sponsor Role: collaborator

University of Bergen

OTHER

Sponsor Role: collaborator

Helse Møre og Romsdal HF

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dag Arne Lihaug Hoff, MD, PhD

Role: STUDY_DIRECTOR

Helse Møre og Romsdal Hospital Trust

Locations

Ålesund Hospital, Helse Møre og Romsdal HF

Ålesund, , Norway

Haukeland University Hospital

Bergen, , Norway

Countries

Norway

References

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.

Reference Type: RESULT

PMID: 31319590 (View on PubMed)

Other Identifiers

2018/1825

Identifier Type: -

Identifier Source: org_study_id