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

Dose Range Finding Study for Effects of Marine Protein Hydrolysate as Dietary Supplement in Elderly Active Subjects

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Dietary supplement: marine protein hydrolysate 1234; Dietary supplement: marine protein hydrolysate 2134; Dietary supplement: marine protein hydrolysate 3124; Dietary supplement: marine protein hydrolysate 4123

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
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Bergen, Norway
    • Haukeland University Hospital
  • Ålesund, Norway
    • Ålesund Hospital, Helse Møre og Romsdal HF

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / 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."

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose	Postprandial glucose (mmol/L) curve on day 7 in each sequence	A standardized meal, thereafter repeated measures every 20 minutes for 2 hours on day 7 in each intervention sequence

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insulin	Postprandial Insulin (mIE/L) - curve on day 7 in each sequence	After the standardized breakfast meal, repeated measure every 20 minutes for 2 hours, on day 7 in each intervention sequence
Hormon 1	Glucagon like peptide 1 (GLP-1) pmol/l - curve, on day 7 in each sequence	At 6 different times point during a 2 hours period, on day 7 in each intervention sequence
Visual analogue scale (VAS)	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.	Before breakfast on each study day (day 7 in each intervention sequence)
KANE, symptom score	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.	Two hours after breakfast on day 1 and 7 in each intervention sequence

Collaborators and Investigators

• Sponsor: Helse Møre og Romsdal HF
• Collaborators: Haukeland University Hospital

Publications and helpful links

General Publications

• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 27, 2018
• Primary Completion (ACTUAL): November 14, 2018
• Study Completion (ACTUAL): November 14, 2018

Study Registration Dates

• First Submitted: April 26, 2018
• First Submitted That Met QC Criteria: May 4, 2018
• First Posted (ACTUAL): May 16, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 17, 2020
• Last Update Submitted That Met QC Criteria: February 12, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Aged; Dietary Supplements; Fish Proteins; Protein Hydrolysates
• Other Study ID Numbers: 2017/1795

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No