Marine Protein Hydrolysate as Dietary Supplement in Elderly Part II

NCT ID: NCT03526744

Last Updated: 2020-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-27

Study Completion Date

2018-11-14

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.

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

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.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

marine protein hydrolysate 1234

Intervention Type DIETARY_SUPPLEMENT

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."

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.

Group Type EXPERIMENTAL

marine protein hydrolysate 2134

Intervention Type DIETARY_SUPPLEMENT

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."

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.

Group Type EXPERIMENTAL

marine protein hydrolysate 3124

Intervention Type DIETARY_SUPPLEMENT

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."

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.

Group Type EXPERIMENTAL

marine protein hydrolysate 4123

Intervention Type DIETARY_SUPPLEMENT

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."

Interventions

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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."

Intervention Type 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."

Intervention Type 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."

Intervention Type 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."

Intervention Type DIETARY_SUPPLEMENT

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
Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Haukeland University Hospital

OTHER

Sponsor Role collaborator

Helse Møre og Romsdal HF

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dag Arne Lihaug Hoff, md phd

Role: STUDY_DIRECTOR

Helse Møre & Romsdal HF, Ålesund Hospital

Locations

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Ålesund Hospital, Helse Møre og Romsdal HF

Ålesund, , Norway

Site Status

Haukeland University Hospital

Bergen, , Norway

Site Status

Countries

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Norway

References

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Jensen C, Dale HF, Hausken T, Lied E, Hatlebakk JG, Bronstad I, Lied GA, Hoff DAL. Supplementation with cod protein hydrolysate in older adults: a dose range cross-over study. J Nutr Sci. 2019 Dec 4;8:e40. doi: 10.1017/jns.2019.37.

Reference Type RESULT
PMID: 32042407 (View on PubMed)

Related Links

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Other Identifiers

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2017/1795

Identifier Type: -

Identifier Source: org_study_id

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