Marine Protein Hydrolysate as Dietary Supplement in Elderly Part II

Study Overview
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Brief Summary
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The aim of this study is to investigate the potential effect of different doses of MPH supplement on glucose metabolism, hunger and appetite hormones.

Detailed Description
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The potential use of marine protein hydrolysates (MPH) as a supplement with similar or better health benefits than a regular white fish meal, can be regarded both cost-effective, environmental friendly and sustainable. The aim of this study is to investigate the potential effect of increasing/different doses of MPH supplement on glucose metabolism, hunger and appetite hormones in healthy elderly, to provide a basis for the optimalization of the daily dose for further use of MPH in clinical study protocols in elderly patients with sarcopenia, other inflammatory conditions or abnormal glucose metabolism.

Official Title
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Dose Range Finding Study for Effects of Marine Protein Hydrolysate as Dietary Supplement in Elderly Active Subjects

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Dietary Supplement: marine protein hydrolysate 1234
* Dietary Supplement: marine protein hydrolysate 2134
* Dietary Supplement: marine protein hydrolysate 3124
* Dietary Supplement: marine protein hydrolysate 4123


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent Body mass index (BMI) 20-30 kg/m2 Exclusion Criteria: Suspected allergies against fish or shellfish Low or unstable blood pressure Diabetes mellitus pharmacologically treated Chronic diseases or therapies that are likely to interfere with the evaluation of study results such as known inflammation or muscle loss Acute infections (may be reconsidered for inclusion at a later time) Substance misuse Inability or unwillingness to comply with the requirements of study procedures

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 85 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: Sequential Assignment
Interventional Model Description: A simple open step-up design will be employed with no placebo control, but the sequence will be randomized. Both participant and investigator are blinded for the dose.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: marine protein hydrolysate 1234<br>Daily intake at breakfast of supplementary marine protein hydrolysate (MPH) equivalent to 10, 20, 30 or 40 mg per kg bodyweight during 1 week, followed by 3 similar cycles with other MPH dosages, with up to 7 days wash-out in between. Random sequence of arms. | Dietary Supplement: marine protein hydrolysate 1234<br>* Dietary Supplement for e.g. in this order: MPH 1600 mg for 7 days, than 7 days wash-out. Dietary Supplement: MPH 800 mg for 7 days, than 7 days wash-out. Dietary Supplement: MPH 2400 mg for 7 days, than 7 days wash-out. Dietary Supplement: MPH 3200 mg for 7 days, than 7 days wash-out.<br>|
| Experimental: marine protein hydrolysate 2134<br>Daily intake at breakfast of supplementary marine protein hydrolysate (MPH) equivalent to 10, 20, 30 or 40 mg per kg bodyweight during 1 week, followed by 3 similar cycles with other MPH dosages, with up to 7 days wash-out in between. Random sequence of arms. | Dietary Supplement: marine protein hydrolysate 2134<br>* Dietary Supplement for e.g. in this order: MPH 3200 mg for 7 days, than 7 days wash-out. Dietary Supplement: MPH 800 mg for 7 days, than 7 days wash-out. Dietary Supplement: MPH 2400 mg for 7 days, than 7 days wash-out. Dietary Supplement: MPH 1600 mg for 7 days, than 7 days wash-out.<br>|
| Experimental: marine protein hydrolysate 3124<br>Daily intake at breakfast of supplementary marine protein hydrolysate (MPH) equivalent to 10, 20, 30 or 40 mg per kg bodyweight during 1 week, followed by 3 similar cycles with other MPH dosages, with with up to 7 days-out in between. Random sequence of arms. | Dietary Supplement: marine protein hydrolysate 3124<br>* Dietary Supplement for e.g. in this order: MPH 2400 mg for 7 days, than 7 days wash-out. Dietary Supplement: MPH 3200 mg for 7 days, than 7 days wash-out. Dietary Supplement: MPH 1600 mg for 7 days, than 7 days wash-out. Dietary Supplement: MPH 800 mg for 7 days, than 7 days wash-out.<br>|
| Experimental: marine protein hydrolysate 4123<br>Daily intake at breakfast of supplementary marine protein hydrolysate (MPH) equivalent to 10, 20, 30 or 40 mg per kg bodyweight during 1 week, followed by 3 similar cycles with other MPH dosages, with up to 7 days wash-out in between. Random sequence of arms. | Dietary Supplement: marine protein hydrolysate 4123<br>* Dietary Supplement for e.g. in this order: MPH 1600 mg for 7 days, than 7 days wash-out. Dietary Supplement: MPH 800 mg for 7 days, than 7 days wash-out. Dietary Supplement: MPH 3200 mg for 7 days, than 7 days wash-out. Dietary Supplement: MPH 2400 mg for 7 days, than 7 days wash-out.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose | Postprandial glucose (mmol/L) curve on day 7 in each sequence | A standardized meal, thereafter repeated measures every 20 minutes for 2 hours on day 7 in each intervention sequence | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin | Postprandial Insulin (mIE/L) - curve on day 7 in each sequence | After the standardized breakfast meal, repeated measure every 20 minutes for 2 hours, on day 7 in each intervention sequence | 
| Hormon 1 | Glucagon like peptide 1 (GLP-1) pmol/l - curve, on day 7 in each sequence | At 6 different times point during a 2 hours period, on day 7 in each intervention sequence | 
| 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. | Before breakfast on each study day (day 7 in each intervention sequence) | 
| KANE, symptom score | Assessed by questionaire KANE (Family name of an Author) , 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. | Two hours after breakfast on day 1 and 7 in each intervention sequence | 

 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