NCT03807752

Marin Protein Hydrolysate and Metabolic Syndrome

The Effect of Supplementation With a Marine Protein Hydrolysate in Patients With Metabolic Syndrome

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Helse Møre og Romsdal HF · Other Government
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metabolic Syndrome

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	MPH_active	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.
DIETARY_SUPPLEMENT	MPH_placebo	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.

Timeline

• Start date: 2019-02-15
• Primary completion: 2019-12-31
• Completion: 2020-04-30
• First posted: 2019-01-17
• Last updated: 2020-12-22

Locations

2 sites across 1 country: Norway