Marin Protein Hydrolysate and Metabolic Syndrome

NCT03807752 | Completed

• 1 other identifier: 2018/2163
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 2

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.

Conditions

Metabolic Syndrome

Keywords

Dietary Supplements; Fish Proteins; Protein Hydrolysates

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Insulin

  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

  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

  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

  At baseline and after 8 weeks.

• Body composition 2

  At baseline and after 8 weeks.

Other Outcomes (7)

• Inflammation

  At baseline and after 8 weeks.

• Hormon 2

  Fasted at baseline and after 8 weeks.

• Hormon 1

  Fasted at baseline and after 8 weeks.

Study Arms (2)

MPH_active

ACTIVE COMPARATOR

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

Dietary Supplement: MPH_active

MPH_placebo

PLACEBO COMPARATOR

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

Dietary Supplement: MPH_placebo

Interventions

MPH_active 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_active

MPH_placebo 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.

MPH_placebo

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Suspected allergy against fish or shellfish
• 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

Sponsors & Collaborators

• Helse Møre og Romsdal HF: lead
• Haukeland University Hospital: collaborator
• University of Bergen: collaborator

Study Sites (2)

Ålesund Hospital, Helse Møre og Romsdal HF

Ålesund, Norway

Location

Haukeland University Hospital

Bergen, Norway

Location

Related Publications (2)

• 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.

  PMID: 33171589 BACKGROUND

• 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.

  PMID: 32635503 RESULT

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Dag Arne Lihaug Hoff, MD, PhD

  Helse Møre og Romsdal Hospital Trust

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: A parallel group randomized, controlled clinical trial for eight weeks

Study Record Dates

• First Submitted: January 15, 2019
• First Posted: January 17, 2019
• Study Start: February 15, 2019
• Primary Completion: December 31, 2019
• Study Completion: April 30, 2020
• Last Updated: December 22, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

NO (2)