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Completed

NCT Number: NCT03807752

Marin Protein Hydrolysate and 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.

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Key information

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haukeland University Hospital, Bergen, Norway

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MPH_active

Dietary Supplement

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.

MPH_placebo

Dietary Supplement

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.

Primary outcomes

  1. Glucose

    Time frame: 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).

    Postprandial glucose (mmol/L) change at baseline and after 8 weeks on intervention.

Secondary outcomes

  1. Insulin

    Time frame: 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).

    Postprandial insulin (mmol/L) change at baseline and after 8 weeks on intervention.

  2. Hormon hunger 1

    Time frame: At baseline and after 8 weeks, the first sample fasted, thereafter repeated samples (i.e - 15, 0, 20, 40, 80, 120 minutes after baseline).

    Glucagon like peptide 1 (GLP-1) pmol/l at baseline and after 8 weeks on intervention.

  3. Hormon hunger 2

    Time frame: At baseline and after 8 weeks, the first sample fasted, thereafter repeated samples (i.e - 15, 0, 20, 40, 80, 120 minutes after baseline).

    Ghrelin at baseline and after 8 weeks on intervention.

  4. Body composition 1

    Time frame: At baseline and after 8 weeks.

    Bioimpedance at baseline and after 8 weeks on intervention.

  5. Body composition 2

    Time frame: At baseline and after 8 weeks.

    Body mass index at baseline and after 8 weeks on intervention.

  6. Body composition 3

    Time frame: First at baseline and after 8 weeks.

    Waist circumference at baseline and after 8 weeks on intervention.

  7. Glucose_met

    Time frame: At baseline and after 8 weeks.

    Glycated hemoglobin (HBA1c) at baseline and after 8 weeks on intervention.

Other outcomes

  1. Inflammation

    Time frame: At baseline and after 8 weeks.

    High-sensitive C-reactive protein at baseline and after 8 weeks on intervention.

  2. Hormon 2

    Time frame: Fasted at baseline and after 8 weeks.

    Adiponectin at baseline and after 8 weeks on intervention.

  3. Hormon 1

    Time frame: Fasted at baseline and after 8 weeks.

    Leptin at baseline and after 8 weeks on intervention.

  4. Lipid profile 1

    Time frame: Fasted at baseline and after 8 weeks.

    Triglycerides at baseline and after 8 weeks on intervention.

  5. Lipid profile 2

    Time frame: Fasted at baseline and after 8 weeks.

    Total cholesterol at baseline and after 8 weeks on intervention.

  6. Lipid profile 3

    Time frame: Fasted at baseline and after 8 weeks.

    HDL-cholesterol at baseline and after 8 weeks on intervention.

  7. Lipid profile 4

    Time frame: Fasted at baseline and after 8 weeks.

    LDL-cholesterol at baseline and after 8 weeks on intervention.

Sponsors and collaborators

Lead sponsor

Helse Møre og Romsdal HF

Other Gov

Collaborators

  • Haukeland University Hospital
  • University of Bergen

Registry information

Official study title

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

Acronym: MPH_MetS

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Jan 17, 2019
Registry last updated
Dec 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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