Marin Protein Hydrolysate and Metabolic Syndrome (MPH_MetS)

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

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Dietary supplement: MPH_active; Dietary supplement: MPH_placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Bergen, Norway
    • Haukeland University Hospital
  • Ålesund, Norway
    • Ålesund Hospital, Helse Møre og Romsdal HF

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Age 40-70 years

• BMI 27-35 kg/m2
• Signed informed consent

• MetS as defined by the presence of at least 3 of the 5 following criteria*:

  • Elevated waist circumference ≥ 94 cm (M), ≥ 80 cm (F)
  • Elevated triglycerides ≥ 1.7 mmol/L (150 mg/dL)
  • Elevated fasting glucose ≥ 5.5 mmol/L (100 mg/dL)
  • Elevated blood pressure S ≥ 130 and/or D ≥85 mmHg

  • Reduced HDL-cholesterol < 1.0 mmol/L (40 mg/dL) (M) <1.3 mmol/L (50 mg/dL) (F)

    • The International Diabetes Foundations (IDF) cut-off points are used.

Exclusion Criteria:

• Suspected allergy against fish or shellfish
• Acute infections (may be reconsidered for inclusion at a later time)
• Chronic disease or therapies that is likely to interfere with the evaluation study results
• Pregnancy, lactation or planning pregnancy during study period
• Substance misuse
• Inability or unwillingness to comply with the requirements of study procedures

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: MPH_active; Daily intake at breakfast of supplementary marine protein hydrolysate (MPH). Random sequence of arms.	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.
Placebo Comparator: MPH_placebo; Daily intake at breakfast of supplementary placebo. 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose	Postprandial glucose (mmol/L) change at baseline and after 8 weeks on intervention.	At baseline and after 8 weeks, the first sample fasted, thereafter repeated samples every 20 minutes (i.e. -15, 0, 20, 40, 60, 80, 100,120 minutes after baseline).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insulin	Postprandial insulin (mmol/L) change at baseline and after 8 weeks on intervention.	At baseline and after 8 weeks, the first sample fasted, thereafter repeated samples every 20 minutes (i.e. -15, 0, 20, 40, 60, 80, 100,120 minutes after baseline).
Hormon hunger 1	Glucagon like peptide 1 (GLP-1) pmol/l at baseline and after 8 weeks on intervention.	At baseline and after 8 weeks, the first sample fasted, thereafter repeated samples (i.e - 15, 0, 20, 40, 80, 120 minutes after baseline).
Hormon hunger 2	Ghrelin at baseline and after 8 weeks on intervention.	At baseline and after 8 weeks, the first sample fasted, thereafter repeated samples (i.e - 15, 0, 20, 40, 80, 120 minutes after baseline).
Body composition 1	Bioimpedance at baseline and after 8 weeks on intervention.	At baseline and after 8 weeks.
Body composition 2	Body mass index at baseline and after 8 weeks on intervention.	At baseline and after 8 weeks.
Body composition 3	Waist circumference at baseline and after 8 weeks on intervention.	First at baseline and after 8 weeks.
Glucose_met	Glycated hemoglobin (HBA1c) at baseline and after 8 weeks on intervention.	At baseline and after 8 weeks.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammation	High-sensitive C-reactive protein at baseline and after 8 weeks on intervention.	At baseline and after 8 weeks.
Hormon 2	Adiponectin at baseline and after 8 weeks on intervention.	Fasted at baseline and after 8 weeks.
Hormon 1	Leptin at baseline and after 8 weeks on intervention.	Fasted at baseline and after 8 weeks.
Lipid profile 1	Triglycerides at baseline and after 8 weeks on intervention.	Fasted at baseline and after 8 weeks.
Lipid profile 2	Total cholesterol at baseline and after 8 weeks on intervention.	Fasted at baseline and after 8 weeks.
Lipid profile 3	HDL-cholesterol at baseline and after 8 weeks on intervention.	Fasted at baseline and after 8 weeks.
Lipid profile 4	LDL-cholesterol at baseline and after 8 weeks on intervention.	Fasted at baseline and after 8 weeks.

Collaborators and Investigators

• Sponsor: Helse Møre og Romsdal HF
• Collaborators: University of Bergen; Haukeland University Hospital
• Investigators: Study Director: Dag Arne Lihaug Hoff, MD, PhD, Helse Møre og Romsdal Hospital Trust

Publications and helpful links

General Publications

• Jensen C, Dale HF, Hausken T, Hatlebakk JG, Brønstad I, Lied GA, Hoff DAL. The Effect of Supplementation with Low Doses of a Cod Protein Hydrolysate on Satiety Hormones and Inflammatory Biomarkers in Adults with Metabolic Syndrome: A Randomized, Double-Blind Study. Nutrients. 2020 Nov 8;12(11). pii: E3421. doi: 10.3390/nu12113421.
• Jensen C, Fjeldheim Dale H, Hausken T, Hatlebakk JG, Bronstad I, Lied GA, Hoff DAL. Supplementation with Low Doses of a Cod Protein Hydrolysate on Glucose Regulation and Lipid Metabolism in Adults with Metabolic Syndrome: A Randomized, Double-Blind Study. Nutrients. 2020 Jul 4;12(7):1991. doi: 10.3390/nu12071991.

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2019
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): April 30, 2020

Study Registration Dates

• First Submitted: January 15, 2019
• First Submitted That Met QC Criteria: January 15, 2019
• First Posted (Actual): January 17, 2019

Study Record Updates

• Last Update Posted (Actual): December 22, 2020
• Last Update Submitted That Met QC Criteria: December 21, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Dietary Supplements; Fish Proteins; Protein Hydrolysates
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: 2018/2163

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No