Marine Protein Hydrolysate as Dietary Supplement in Elderly Part I

NCT ID: NCT03669796

Last Updated: 2019-11-14

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

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-27

Study Completion Date

2018-02-28

Brief Summary

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The aim of this study is to investigate the potential effect of a marine protein hydrolysate (MPH) supplement before a meal on postprandial glucose tolerance in healthy subjects, to achieve more knowledge on this presumed beneficial, blood glucose lowering effect

Detailed Description

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To further investigate the effects of MPH in a single dose of 20 mg/kg of body weight on postprandial blood glucose, insulin and GLP-1 (as markers of glucose metabolism) in healthy, active middle-aged to elderly subjects - age 40-65 years.

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

A double-blind crossover trial, including two different study days, with 4-7 days wash-out (WO) period in between. The intervention implemented 20 mg of MPH per kg body weight (test material) or control (casein).
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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supplementary Marine protein hydrolysate

20 mg powder per kg body weight of Marine protein hydrolysate (MPH)

Group Type EXPERIMENTAL

Marine protein hydrolysate (mph)

Intervention Type DIETARY_SUPPLEMENT

Marine (Cod) protein hydrolysate

control

20 mg powder per kg body weight of casein/maltodextrin

Group Type PLACEBO_COMPARATOR

Control

Intervention Type DIETARY_SUPPLEMENT

Maltodextrin/Casein

Interventions

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Marine protein hydrolysate (mph)

Marine (Cod) protein hydrolysate

Intervention Type DIETARY_SUPPLEMENT

Control

Maltodextrin/Casein

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Signed informed consent
* Body mass index (BMI) 20-30

Exclusion Criteria

* Suspected allergies against fish or shellfish
* Low or unstable blood pressure
* Diabetes mellitus, treated pharmacological
* Chronic diseases or therapies that is likely to interfere with the evaluation of study results
* Acute infections (may be reconsidered for inclusion at a later time)
* Allergic to milk, confirmed diagnose
* Pregnancy
* Women who are breast-feeding infants
* Inability or unwillingness to comply with the requirements of study procedures
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 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

Møre & Romsdal Hospital Trust, 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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Dale HF, Jensen C, Hausken T, Lied E, Hatlebakk JG, Bronstad I, Lihaug Hoff DA, Lied GA. Effect of a cod protein hydrolysate on postprandial glucose metabolism in healthy subjects: a double-blind cross-over trial. J Nutr Sci. 2018 Nov 28;7:e33. doi: 10.1017/jns.2018.23. eCollection 2018.

Reference Type RESULT
PMID: 30524707 (View on PubMed)

Dale HF, Jensen C, Hausken T, Lied E, Hatlebakk JG, Bronstad I, Hoff DAL, Lied GA. Erratum: Effect of a cod protein hydrolysate on postprandial glucose metabolism in healthy subjects: a double-blind cross-over trial - CORRIGENDUM. J Nutr Sci. 2019 Jan 18;8:e1. doi: 10.1017/jns.2018.30. eCollection 2019.

Reference Type RESULT
PMID: 30719283 (View on PubMed)

Dale HF, Jensen C, Hausken T, Lied E, Hatlebakk JG, Bronstad I, Hoff DAL, Lied GA. Acute effect of a cod protein hydrolysate on postprandial acylated ghrelin concentration and sensations associated with appetite in healthy subjects: a double-blind crossover trial. Food Nutr Res. 2019 Oct 22;63. doi: 10.29219/fnr.v63.3507. eCollection 2019.

Reference Type RESULT
PMID: 31692759 (View on PubMed)

Other Identifiers

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2017/1794

Identifier Type: -

Identifier Source: org_study_id

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