Marin Protein Hydrolysate and Metabolic Syndrome

Study Overview
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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.

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

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Dietary Supplement: MPH_active
* Dietary Supplement: MPH_placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A parallel group randomized, controlled clinical trial for eight weeks
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MPH_active<br>Daily intake at breakfast of supplementary marine protein hydrolysate (MPH). Random sequence of arms. | Dietary Supplement: MPH_active<br>* 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.<br>|
| Placebo Comparator: MPH_placebo<br>Daily intake at breakfast of supplementary placebo. Random sequence of arms. | Dietary Supplement: MPH_placebo<br>* 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.<br>|

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dietary Supplements, Fish Proteins, Protein Hydrolysates