Clinical trial NCT03807752: Marin Protein Hydrolysate and Metabolic Syndrome
Official title: The Effect of Supplementation With a Marine Protein Hydrolysate in Patients With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Keywords: Dietary Supplements
Fish Proteins
Protein Hydrolysates
Lead sponsor: Helse Møre og Romsdal HF
Sponsor class: OTHER_GOV
Collaborators: name: Haukeland University Hospital
name: University of Bergen
First posted: 2019-01-17
Enrollment: 33
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A parallel group randomized, controlled clinical trial for eight weeks
Primary purpose: TREATMENT

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.

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 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.

Eligibility 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

Primary outcomes:
measure: Glucose
timeFrame: 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 outcomes:
measure: Insulin
timeFrame: 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).
measure: Hormon hunger 1
timeFrame: At baseline and after 8 weeks, the first sample fasted, thereafter repeated samples (i.e - 15, 0, 20, 40, 80, 120 minutes after baseline).
measure: Hormon hunger 2
timeFrame: At baseline and after 8 weeks, the first sample fasted, thereafter repeated samples (i.e - 15, 0, 20, 40, 80, 120 minutes after baseline).
measure: Body composition 1
timeFrame: At baseline and after 8 weeks.
measure: Body composition 2
timeFrame: At baseline and after 8 weeks.
measure: Body composition 3
timeFrame: First at baseline and after 8 weeks.
measure: Glucose_met
timeFrame: At baseline and after 8 weeks.
Other outcomes:
measure: Inflammation
timeFrame: At baseline and after 8 weeks.
measure: Hormon 2
timeFrame: Fasted at baseline and after 8 weeks.
measure: Hormon 1
timeFrame: Fasted at baseline and after 8 weeks.
measure: Lipid profile 1
timeFrame: Fasted at baseline and after 8 weeks.
measure: Lipid profile 2
timeFrame: Fasted at baseline and after 8 weeks.
measure: Lipid profile 3
timeFrame: Fasted at baseline and after 8 weeks.
measure: Lipid profile 4
timeFrame: Fasted at baseline and after 8 weeks.
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Ålesund
country: Norway
facility: Ålesund Hospital, Helse Møre og Romsdal HF
Study officials:
affiliation: Helse Møre og Romsdal Hospital Trust
name: Dag Arne Lihaug Hoff, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.