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Completed

NCT Number: NCT03529344

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

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.

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Key information

Conditions

Muscle Weakness Aging Atrophy Blood Sugar; High Glucose Metabolism Disorders Hyperglycemia Inflammation Metabolic Diseases Muscle Loss Muscular Atrophy Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blue whiting protein hydrolysate

Dietary Supplement

Dietary Supplement: Blue whiting protein hydrolysate 6g protein per day for 6wk

Placebo Comparator: Control

Dietary Supplement

Control group will receive non-caloric juice without protein supplementation

Primary outcomes

  1. Participant compliance

    Time frame: 6 weeks

    Investigate the participant compliance based daily registrations by nursing home staff

  2. Participant dropout rate

    Time frame: 6 weeks

    Number of participants that completed the intervention period

Secondary outcomes

  1. Glucose regulation

    Time frame: 6 weeks

    Glucose concentration will be measured in fasting serum

  2. Insulin

    Time frame: 6 weeks

    Insulin will be measured in fasting serum/plasma

  3. C-reactive protein in serum

    Time frame: 6 weeks

    C-reactive protein (a marker of inflammation) will be analysed in fasting serum

  4. Interleukin-6 in serum

    Time frame: 6 weeks

    Interleukin-6 (a marker of inflammation) will be analysed in fasting serum

  5. Monocyte chemoattractant protein-1 in serum

    Time frame: 6 weeks

    Monocyte chemoattractant protein-1 (a marker of inflammation) will be analysed in fasting serum

Sponsors and collaborators

Lead sponsor

University of Bergen

Other

Registry information

Official study title

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

Acronym: GRIPE

Important dates

Study start
2016
Primary completion
2018
Study completion
2021
First posted
May 18, 2018
Registry last updated
Jan 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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