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Marine Protein Hydrolysate as Dietary Supplement in Elderly Part II (MPH-DR)

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ClinicalTrials.gov Identifier: NCT03526744
Recruitment Status : Recruiting
First Posted : May 16, 2018
Last Update Posted : September 12, 2018
Sponsor:
Collaborator:
Haukeland University Hospital
Information provided by (Responsible Party):
Helse Møre og Romsdal HF

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

Condition or disease Intervention/treatment Phase
Healthy Volunteers Dietary Supplement: marine protein hydrolysate 1234 Dietary Supplement: marine protein hydrolysate 2134 Dietary Supplement: marine protein hydrolysate 3124 Dietary Supplement: marine protein hydrolysate 4123 Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Sequential 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: Double (Participant, Investigator)
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 1234
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
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."

Experimental: marine protein hydrolysate 2134
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
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."

Experimental: marine protein hydrolysate 3124
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
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."

Experimental: marine protein hydrolysate 4123
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
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."




Primary Outcome Measures :
  1. Glucose [ Time Frame: A standardized meal, thereafter repeated measures every 20 minutes for 2 hours on day 7 in each intervention sequence ]
    Postprandial glucose (mmol/L) curve on day 7 in each sequence


Secondary Outcome Measures :
  1. Insulin [ Time Frame: After the standardized beakfast meal, repeated measure every 20 minutes for 2 hours, on day 7 in each intervention sequence ]
    Postprandial Insulin (mIE/L) - curve on day 7 in each sequence

  2. Hormon 1 [ Time Frame: At 6 different times point during a 2 hours period, on day 7 in each intervention sequence ]
    Glucagon like peptide 1 (GLP-1) pmol/l - curve, on day 7 in each sequence

  3. Visual analogue scale (VAS) [ Time Frame: Before breakfast on each study day (day 7 in each intervention sequence) ]
    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.

  4. KANE, symptom score [ Time Frame: Two hours after breakfast on day 1 and 7 in each intervention sequence ]
    ssessed 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.



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Ages Eligible for Study:   60 Years to 85 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: September 12, 2018
Last Verified: September 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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