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Completed

NCT Number: NCT03669796

Marine Protein Hydrolysate as Dietary Supplement in Elderly Part I

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

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Key information

Conditions

Healthy Volunteers

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haukeland University Hospital, Bergen, Norway

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Marine protein hydrolysate (mph)

Dietary Supplement

Marine (Cod) protein hydrolysate

Control

Dietary Supplement

Maltodextrin/Casein

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Helse Møre og Romsdal HF

Other Gov

Collaborators

  • Haukeland University Hospital

Registry information

Official study title

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

Acronym: MPH-BS

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 13, 2018
Registry last updated
Nov 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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