A Study on the Effects on Glucose Regulation, Inflammation and Serum Lipids After Fish Protein Supplementation in Elderly (GRIPE)

Study Overview
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Brief Summary
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The elderly population have and increased risk of loss of both muscle mass and function and is therefore recommended a higher protein intake than the healthy adult population. These age-related changes in muscle function may be explained by chronic low-grade inflammation and insulin resistance. Despite the recommendation of a higher protein intake, little is known about how different protein sources may affect the metabolic health in this population. Analysis of amino acid composition show that fish can be a good protein source for humans. Many fish species are today used as feed ingredients, rather than a protein source for humans. A few studies conducted in humans and rats show that proteins from fish may improve glucose tolerance, reduce inflammation and improve lipid metabolism, indicating that proteins from fish may not only serve as a valuable nutrient but could also hold specific health promoting properties. The present study will investigate the effects of a protein hydrolysate from blue whiting, a fish species normally used to produce fish meal for aquaculture industry, on glucose homeostasis, inflammation and serum lipids in elderly nursing home residents.

Detailed Description
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Participants receive 6g per day of protein hydrolysate from blue whiting as protein powder mixed with a non-caloric juice for 6 weeks.

Official Title
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A 6-week Pilot Study to Investigate the Effects of Protein Hydrolysate From Blue Whiting on Glucose Regulation, Inflammation and Serum Lipids in Elderly Nursing Home Residents From Western Norway

Conditions
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Muscle Weakness, Muscle Loss, Blood Sugar; High, Inflammation, Aging

Intervention / Treatment
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* Dietary Supplement: Blue whiting protein hydrolysate
* Dietary Supplement: Placebo Comparator: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >60 years both genders nursing home resident Exclusion Criteria: life expectancy < 6 months severe cognitive impairment allergies towards fish, milk, egg weight loss >5% last 3 months

Ages Eligible for Study
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Minimum Age: 60 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Blue whiting protein hydrolysate<br>Dietary Supplement: Blue whiting protein hydrolysate 6g protein per day for 6wk | Dietary Supplement: Blue whiting protein hydrolysate<br>* Dietary Supplement: Blue whiting protein hydrolysate 6g protein per day for 6wk<br>|
| Placebo Comparator: Placebo Comparator: Control<br>Control group will receive non-caloric juice without protein supplementation | Dietary Supplement: Placebo Comparator: Control<br>* Control group will receive non-caloric juice without protein supplementation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant compliance | Investigate the participant compliance based daily registrations by nursing home staff | 6 weeks | 
| Participant dropout rate | Number of participants that completed the intervention period | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose regulation | Glucose concentration will be measured in fasting serum | 6 weeks | 
| Insulin | Insulin will be measured in fasting serum/plasma | 6 weeks | 
| C-reactive protein in serum | C-reactive protein (a marker of inflammation) will be analysed in fasting serum | 6 weeks | 
| Interleukin-6 in serum | Interleukin-6 (a marker of inflammation) will be analysed in fasting serum | 6 weeks | 
| Monocyte chemoattractant protein-1 in serum | Monocyte chemoattractant protein-1 (a marker of inflammation) will be analysed in fasting serum | 6 weeks |