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Marin Protein Hydrolysate and Metabolic Syndrome

NCT ID: NCT03807752

Last Updated: 2020-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-15

Study Completion Date

2020-04-30

Brief Summary

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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

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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

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Metabolic Syndrome

Keywords

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Dietary Supplements Fish Proteins Protein Hydrolysates

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A parallel group randomized, controlled clinical trial for eight weeks
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
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.

Study Groups

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MPH_active

Daily intake at breakfast of supplementary marine protein hydrolysate (MPH). Random sequence of arms.

Group Type ACTIVE_COMPARATOR

MPH_active

Intervention Type 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

Daily intake at breakfast of supplementary placebo. Random sequence of arms.

Group Type PLACEBO_COMPARATOR

MPH_placebo

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Haukeland University Hospital

OTHER

Sponsor Role collaborator

University of Bergen

OTHER

Sponsor Role collaborator

Helse Møre og Romsdal HF

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dag Arne Lihaug Hoff, MD, PhD

Role: STUDY_DIRECTOR

Helse Møre og Romsdal Hospital Trust

Locations

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Ålesund Hospital, Helse Møre og Romsdal HF

Ålesund, , Norway

Site Status

Haukeland University Hospital

Bergen, , Norway

Site Status

Countries

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Norway

References

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Jensen C, Dale HF, Hausken T, Hatlebakk JG, Bronstad 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):3421. doi: 10.3390/nu12113421.

Reference Type BACKGROUND
PMID: 33171589 (View on PubMed)

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.

Reference Type RESULT
PMID: 32635503 (View on PubMed)

Other Identifiers

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2018/2163

Identifier Type: -

Identifier Source: org_study_id