Marin Protein Hydrolysate and Metabolic Syndrome

Metabolic Syndrome Clinical Trial

— MPH_MetS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03807752
• Other study ID #: 2018/2163
• Status: Completed
• Phase: N/A
• Start date: February 15, 2019
• Est. completion date: April 30, 2020

Study information

• Verified date: December 2020
• Source: Helse Møre og Romsdal HF
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: April 30, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
Norway	Ålesund Hospital, Helse Møre og Romsdal HF	Ålesund
Norway	Haukeland University Hospital	Bergen

Sponsors (3)

Lead Sponsor	Collaborator
Helse Møre og Romsdal HF	Haukeland University Hospital, University of Bergen

Country where clinical trial is conducted

Norway, 

References & Publications (2)

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. — View Citation

Jensen C, Fjeldheim Dale H, Hausken T, Hatlebakk JG, Brønstad 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Inflammation	High-sensitive C-reactive protein at baseline and after 8 weeks on intervention.	At baseline and after 8 weeks.
Other	Hormon 2	Adiponectin at baseline and after 8 weeks on intervention.	Fasted at baseline and after 8 weeks.
Other	Hormon 1	Leptin at baseline and after 8 weeks on intervention.	Fasted at baseline and after 8 weeks.
Other	Lipid profile 1	Triglycerides at baseline and after 8 weeks on intervention.	Fasted at baseline and after 8 weeks.
Other	Lipid profile 2	Total cholesterol at baseline and after 8 weeks on intervention.	Fasted at baseline and after 8 weeks.
Other	Lipid profile 3	HDL-cholesterol at baseline and after 8 weeks on intervention.	Fasted at baseline and after 8 weeks.
Other	Lipid profile 4	LDL-cholesterol at baseline and after 8 weeks on intervention.	Fasted at baseline and after 8 weeks.
Primary	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	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).
Secondary	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).
Secondary	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).
Secondary	Body composition 1	Bioimpedance at baseline and after 8 weeks on intervention.	At baseline and after 8 weeks.
Secondary	Body composition 2	Body mass index at baseline and after 8 weeks on intervention.	At baseline and after 8 weeks.
Secondary	Body composition 3	Waist circumference at baseline and after 8 weeks on intervention.	First at baseline and after 8 weeks.
Secondary	Glucose_met	Glycated hemoglobin (HBA1c) at baseline and after 8 weeks on intervention.	At baseline and after 8 weeks.