Marine Protein Hydrolysate as Dietary Supplement in Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional

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.
    

Intervention name(s): MPH_active; MPH_placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A parallel group randomized, controlled clinical trial for six weeks
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Dietary Supplements; Fish Proteins; Protein Hydrolysates