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

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ClinicalTrials.gov Identifier: NCT03669796
Recruitment Status : Completed
First Posted : September 13, 2018
Last Update Posted : August 14, 2019
Sponsor:
Collaborator:
Haukeland University Hospital
Information provided by (Responsible Party):
Helse Møre og Romsdal HF

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Healthy Volunteers Dietary Supplement: Marine protein hydrolysate (mph) Dietary Supplement: Control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: A double-blind crossover trial, including two different study days, with 4-7 days wash-out (WO) period in between. The intervention implemented 20 mg of MPH per kg body weight (test material) or control (casein).
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Study of the Effects of Marine Protein Hydrolysate as Dietary Supplement on the Regulation of Postprandial Blood Glucose Metabolism in Healthy Subjects
Actual Study Start Date : November 27, 2017
Actual Primary Completion Date : February 28, 2018
Actual Study Completion Date : February 28, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03669796


Locations
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Norway
Haukeland University Hospital
Bergen, Norway
Ålesund Hospital, Helse Møre og Romsdal HF
Ålesund, Norway
Sponsors and Collaborators
Helse Møre og Romsdal HF
Haukeland University Hospital
Investigators
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Study Director: Dag Arne Lihaug Hoff, MD, PhD Møre & Romsdal Hospital Trust, Ålesund Hospital

Publications of Results:
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Responsible Party: Helse Møre og Romsdal HF
ClinicalTrials.gov Identifier: NCT03669796     History of Changes
Other Study ID Numbers: 2017/1794
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Helse Møre og Romsdal HF:
Dietary Supplements
Fish Proteins
Protein Hydrolysates
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