Marine Protein Hydrolysate as Dietary Supplement in Elderly Part I

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Dietary Supplement: Marine protein hydrolysate (mph)
* Dietary Supplement: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose | 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 | 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 | 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) | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dietary Supplements, Fish Proteins, Protein Hydrolysates, Aged