Marine Protein Hydrolysate as Dietary Supplement in Elderly Part I

Not Applicable

Completed

• Conditions: Healthy Volunteers
• Interventions: Dietary Supplement: Marine protein hydrolysate (mph); Dietary Supplement: Control

• Registration Number: NCT03669796
• Lead Sponsor: 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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-11-27
• Primary Completion: 2018-02-28
• Study Completion: 2018-02-28
• Study First Submitted: 2018-07-02
• Study First Submitted QC: 2018-09-12
• Study First Posted: 2018-09-13
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-12
• Last Update Posted: 2019-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
supplementary Marine protein hydrolysate	Marine protein hydrolysate (mph)	20 mg powder per kg body weight of Marine protein hydrolysate (MPH)
control	Control	20 mg powder per kg body weight of casein/maltodextrin

Primary Outcome Measures

Name	Time	Method
Glucose	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

Name	Time	Method
Insulin	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
Hormon 1	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
Visual analogue scale (VAS)	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.
KANE, symptom score	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.

Trial Locations

Locations (2)

Ålesund Hospital, Helse Møre og Romsdal HF; 🇳🇴 Ålesund, Norway

Haukeland University Hospital; 🇳🇴 Bergen, Norway