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Marine Protein Hydrolysate as Dietary Supplement in Elderly

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ClinicalTrials.gov Identifier: NCT03526744
Recruitment Status : Recruiting
First Posted : May 16, 2018
Last Update Posted : May 16, 2018
Sponsor:
Collaborator:
Haukeland University Hospital
Information provided by (Responsible Party):
Helse Møre og Romsdal HF

Brief Summary:
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 urinary nitrogen retention 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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Dietary Supplement: marine protein hydrolysate 800-1600-2400-3200 mg Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention 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: None (Open Label)
Primary Purpose: Basic Science
Official Title: Dose Range Finding Study for Effects of Marine Protein Hydrolysate as Dietary Supplement in Elderly Active Subjects
Actual Study Start Date : April 27, 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: marine protein hydrolysate
Daily intake at breakfast of supplementary marine protein hydrolysate (MPH) equivalent to 10, 20, 30 and 40 mg per kg bodyweight (i.e. standardized to a 80 kg person, adjusted to the actual weight of the participants) during 1 week, followed by 3 similar cycles with other MPH dosages, with 1-2 wash-out weeks in between. Random sequence of cycles.
Dietary Supplement: marine protein hydrolysate 800-1600-2400-3200 mg
Dietary Supplement: MPH 800 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 2400 mg for 7 days, than 7 days wash-out. Dietary Supplement: MPH 3200 mg for 7 days, than 7 days wash-out."
Other Name: MPH




Primary Outcome Measures :
  1. Urinary nitrogen retention [ Time Frame: 7 weeks ]
    assessed by nitrogen balance method, which measures whole body protein balance in response to exercise or nutritional interventions. Premise: a fluctuation in nitrogen reflects a change in total body protein



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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03526744


Contacts
Contact: Dag Arne Lihaug Hoff, md phd + 47 70105000 dag.hoff@helse-mr.no

Locations
Norway
Haukeland University Hospital Recruiting
Bergen, Norway
Contact: Hanna Fjeldheim Dale    +47 98088495    hanna.fjeldheim.dale@helse-bergen.no   
Contact: Caroline Jensen    +47 97078964    caroline.jensen@helse-bergen.no   
Ålesund Hospital, Helse Møre og Romsdal HF Recruiting
Ålesund, Norway
Contact: Caroline Jensen    +47 97078964    caroline.jensen@helse-mr.no   
Contact: Hanna Fjeldheim Dale    +4798088495    hanna.fjeldheim.dale@helse-mr.no   
Sponsors and Collaborators
Helse Møre og Romsdal HF
Haukeland University Hospital
Investigators
Study Director: Dag Arne Lihaug Hoff, md phd Helse Møre & Romsdal HF, Ålesund Hospital

Responsible Party: Helse Møre og Romsdal HF
ClinicalTrials.gov Identifier: NCT03526744     History of Changes
Other Study ID Numbers: 2017/1795
First Posted: May 16, 2018    Key Record Dates
Last Update Posted: May 16, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Helse Møre og Romsdal HF:
Dietary Supplements
Fish Proteins
Protein Hydrolysates
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