Marin Protein Hydrolysate and Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      Overweight and obesity are increasing global health problems and the most important
      contributors to morbidity and mortality. The maintenance of long-term weight loss is
      difficult, and individuals often regain weight after an intervention program is finished. It
      is of interest to find ways to prevent and alleviate metabolic syndrome (MetS), beyond the
      known effects of lifestyle modification and weight loss. Fish has been proposed as a food
      that may have favorable effects on metabolic health. There is evidence that cod, and other
      marine fish, may contain bioactive peptides that have potentially important health effects in
      humans. The aim of this study is to investigate the effect of adding a marine protein
      hydrolysate (MPH) supplement to the diet over an 8-week period in a group of adults with
      established MetS. The investigators expect that this will lead to beneficial changes in the
      components of MetS and to an overall healthier metabolic profile.
    

Detailed description: 
      Overweight and obesity are increasing global health problems and the most important
      contributors to morbidity and mortality. Obesity (abdominal obesity), together with
      hyperglycemia, dyslipidemia and hypertension forms a cluster of risk factors that is called
      the metabolic syndrome (MetS). The first-line therapy for MetS is lifestyle intervention -
      education on a healthy lifestyle leading to a focus on physical activity and diet, which will
      improve risk factors closely linked to MetS. The maintenance of long-term weight loss is
      difficult, and individuals often regain weight after an intervention program stops. It is of
      interest to find ways to prevent and alleviate MetS, beyond the known effects of lifestyle
      modification and weight loss. Fish has been proposed as a food that may have favorable
      effects on metabolic health. Previous intervention studies with fish protein in humans and
      rodents have shown improved insulin sensitivity and glucose tolerance, reduced cholesterol
      levels in plasma and reduced blood pressure. Intervention studies investigating the effect of
      cod have mainly focused on the health effect of consuming the whole fillet. Studies on the
      remaining part of the fish, the residual material, primarily used for production of animal
      feed, are scarce. There is evidence that cod, and other marine fish, may contain bioactive
      peptides that have potentially important health effects in humans. Therefore, it is of
      interest to investigate the possible effect of a daily supplement of marine protein
      hydrolysate (MPH), taken over a longer period, in a group of patients with abnormal glucose
      control. The aim of this study is to investigate the effect of adding a MPH supplement to the
      diet over an 8-week period in a group of adults with established MetS. The investigators
      expect that supplementation with MPH will lead to beneficial changes in the components of
      MetS and an overall healthier metabolic profile.
    

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 X mg, duration 8 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 X mg, duration 8 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 eight weeks
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Dietary Supplements; Fish Proteins; Protein Hydrolysates