Marine Protein Hydrolysate as Dietary Supplement in Elderly Part I (MPH-BS)

November 12, 2019 updated by: Helse Møre og Romsdal HF

A Study of the Effects of Marine Protein Hydrolysate as Dietary Supplement on the Regulation of Postprandial Blood Glucose Metabolism in Healthy Subjects

The aim of this study is to investigate the potential effect of a marine protein hydrolysate (MPH) supplement before a meal on postprandial glucose tolerance in healthy subjects, to achieve more knowledge on this presumed beneficial, blood glucose lowering effect

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To further investigate the effects of MPH in a single dose of 20 mg/kg of body weight on postprandial blood glucose, insulin and GLP-1 (as markers of glucose metabolism) in healthy, active middle-aged to elderly subjects - age 40-65 years.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Bergen, Norway
        • Haukeland University Hospital
      • Ålesund, Norway
        • Ålesund Hospital, Helse Møre og Romsdal HF

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed informed consent
  • Body mass index (BMI) 20-30

Exclusion Criteria:

  • Suspected allergies against fish or shellfish
  • Low or unstable blood pressure
  • Diabetes mellitus, treated pharmacological
  • Chronic diseases or therapies that is likely to interfere with the evaluation of study results
  • Acute infections (may be reconsidered for inclusion at a later time)
  • Allergic to milk, confirmed diagnose
  • Pregnancy
  • Women who are breast-feeding infants
  • Inability or unwillingness to comply with the requirements of study procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: supplementary Marine protein hydrolysate
20 mg powder per kg body weight of Marine protein hydrolysate (MPH)
Dietary supplement: Marine protein hydrolysate (mph)
Marine (Cod) protein hydrolysate
Placebo Comparator: control
20 mg powder per kg body weight of casein/maltodextrin
Dietary supplement: Control
Maltodextrin/Casein

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glucose
Time Frame: First sample fasting baseline, thereafter repeated samples every 20 minutes (i.e.20, 40, 60, 80, 100,120,140 minutes after baseline), last at 200 minutes after baseline.
Postprandial glucose (mmol/L) change on each day of intervention
First sample fasting baseline, thereafter repeated samples every 20 minutes (i.e.20, 40, 60, 80, 100,120,140 minutes after baseline), last at 200 minutes after baseline.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin
Time Frame: First sample fasting baseline, thereafter repeated samples every 20 minutes (i.e.20, 40, 60, 80, 100,120,140 minutes after baseline), last at 200 minutes after baseline
Postprandial Insulin (mIE/L) - change on each day of intervention
First sample fasting baseline, thereafter repeated samples every 20 minutes (i.e.20, 40, 60, 80, 100,120,140 minutes after baseline), last at 200 minutes after baseline
Hormon 1
Time Frame: First sample fasting baseline, thereafter repeated samples (i.e.20, 40, 60, 100 minutes after baseline), last at 200 minutes after baseline
Glucagon like peptide 1 (GLP-1) pmol/l change on each day of intervention
First sample fasting baseline, thereafter repeated samples (i.e.20, 40, 60, 100 minutes after baseline), last at 200 minutes after baseline
Visual analogue scale (VAS)
Time Frame: First (baseline) symptomscore (as described above) measured fasting , thereafter repeated symptom score i.e. at 20, 40 minutes after baseline, last symptom score measure at 200 minutes after baseline
Assessed by questionnaire VAS, scale from 0-10, where 0 is minimum score and 10 is the maximum score, reported e.g. as a total score of 7. The higher the reported value is the worse outcome.
First (baseline) symptomscore (as described above) measured fasting , thereafter repeated symptom score i.e. at 20, 40 minutes after baseline, last symptom score measure at 200 minutes after baseline
KANE, symptom score
Time Frame: First (baseline) symptom score (as described above) measured fasting and the next measure at 200 minutes after baseline
Assessed by questionaire KANE (family name) , scale from 0-10, where 0 is minimum score and 10 is the maximum score, reported e.g. as a total score of 7. The higher the reported value is the worse outcome.
First (baseline) symptom score (as described above) measured fasting and the next measure at 200 minutes after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helse Møre og Romsdal HF

Collaborators

Haukeland University Hospital

Investigators

  • Study Director: Dag Arne Lihaug Hoff, MD, PhD, Møre & Romsdal Hospital Trust, Ålesund Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 27, 2017

Primary Completion (Actual)

February 28, 2018

Study Completion (Actual)

February 28, 2018

Study Registration Dates

First Submitted

July 2, 2018

First Submitted That Met QC Criteria

September 12, 2018

First Posted (Actual)

September 13, 2018

Study Record Updates

Last Update Posted (Actual)

November 14, 2019

Last Update Submitted That Met QC Criteria

November 12, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2017/1794

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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