Marine Protein Hydrolysate as Dietary Supplement in Elderly Part II

Not Applicable

Completed

• Conditions: Healthy Volunteers
• Interventions: Dietary Supplement: marine protein hydrolysate 1234; Dietary Supplement: marine protein hydrolysate 2134; Dietary Supplement: marine protein hydrolysate 3124; Dietary Supplement: marine protein hydrolysate 4123

• Registration Number: NCT03526744
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-04-26
• Study Start: 2018-04-27
• Study First Submitted QC: 2018-05-04
• Study First Posted: 2018-05-16
• Primary Completion: 2018-11-14
• Study Completion: 2018-11-14
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-12
• Last Update Posted: 2020-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Signed informed consent
• Body mass index (BMI) 20-30 kg/m2

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
marine protein hydrolysate 1234	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.
marine protein hydrolysate 2134	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.
marine protein hydrolysate 3124	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.
marine protein hydrolysate 4123	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.

Primary Outcome Measures

Name	Time	Method
Glucose	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

Name	Time	Method
Insulin	After the standardized breakfast 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
Hormon 1	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
Visual analogue scale (VAS)	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.
KANE, symptom score	Two hours after breakfast on day 1 and 7 in each intervention sequence	Assessed 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.

Trial Locations

Locations (2)

Ålesund Hospital, Helse Møre og Romsdal HF; 🇳🇴 Ålesund, Norway

Haukeland University Hospital; 🇳🇴 Bergen, Norway