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Marin Protein Hydrolysate and Metabolic Syndrome (MPH_MetS)

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ClinicalTrials.gov Identifier: NCT03807752
Recruitment Status : Recruiting
First Posted : January 17, 2019
Last Update Posted : February 26, 2019
Sponsor:
Collaborators:
Haukeland University Hospital
University of Bergen
Information provided by (Responsible Party):
Helse Møre og Romsdal HF

Brief 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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Dietary Supplement: MPH_active Dietary Supplement: MPH_placebo Not Applicable

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 foucus 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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)
Masking Description: The provider of the dietary supplement deliver the supplement prepared and packed in equal bags (active/placebo) that we hand out to the participants in an randomized order.
Primary Purpose: Treatment
Official Title: The Effect of Supplementation With a Marine Protein Hydrolysate in Patients With Metabolic Syndrome
Actual Study Start Date : February 15, 2019
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03807752


Contacts
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Contact: Dag Arne Lihaug Hoff, MD, PhD +4770105000 dag.hoff@helse-mr.no
Contact: Jan Gunnar Hatlebakk, MD, PhD +4755975000 jan.gunnar.hatlebakk@helse-bergen.no

Locations
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Norway
Haukeland University Hospital Recruiting
Bergen, Norway
Contact: Hanna Fjeldheim Dale, Msc    +4798088495    hanna.fjeldheim.dale@helse-bergen.no   
Contact: Caroline Jensen, Msc    +4797078964    caroline.jensen@helse-bergen.no   
Ålesund Hospital, Helse Møre og Romsdal HF Recruiting
Ålesund, Norway
Contact: Caroline Jensen, Msc    +47 97078964    caroline.jensen@helse-mr.no   
Contact: Hanna Fjeldheim Dale, Msc    +4798088495    hanna.fjeldheim.dale@helse-mr.no   
Sponsors and Collaborators
Helse Møre og Romsdal HF
Haukeland University Hospital
University of Bergen
Investigators
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Study Director: Dag Arne Lihaug Hoff, MD, PhD Helse Møre og Romsdal Hospital trust

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Responsible Party: Helse Møre og Romsdal HF
ClinicalTrials.gov Identifier: NCT03807752     History of Changes
Other Study ID Numbers: 2018/2163
First Posted: January 17, 2019    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Helse Møre og Romsdal HF:
Dietary Supplements
Fish Proteins
Protein Hydrolysates

Additional relevant MeSH terms:
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Syndrome
Metabolic Syndrome
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases