Clinical trial NCT03526744: Marine Protein Hydrolysate as Dietary Supplement in Elderly Part II
Official title: Dose Range Finding Study for Effects of Marine Protein Hydrolysate as Dietary Supplement in Elderly Active Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: Dietary Supplements
Fish Proteins
Protein Hydrolysates
Aged
Lead sponsor: Helse Møre og Romsdal HF
Sponsor class: OTHER_GOV
Collaborators: name: Haukeland University Hospital
First posted: 2018-05-16
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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

Primary outcomes:
measure: Glucose
timeFrame: A standardized meal, thereafter repeated measures every 20 minutes for 2 hours on day 7 in each intervention sequence
Secondary outcomes:
measure: Insulin
timeFrame: After the standardized breakfast meal, repeated measure every 20 minutes for 2 hours, on day 7 in each intervention sequence
measure: Hormon 1
timeFrame: At 6 different times point during a 2 hours period, on day 7 in each intervention sequence
measure: Visual analogue scale (VAS)
timeFrame: Before breakfast on each study day (day 7 in each intervention sequence)
measure: KANE, symptom score
timeFrame: Two hours after breakfast on day 1 and 7 in each intervention sequence
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Ålesund
country: Norway
facility: Ålesund Hospital, Helse Møre og Romsdal HF
Study officials:
affiliation: Helse Møre & Romsdal HF, Ålesund Hospital
name: Dag Arne Lihaug Hoff, md phd
role: STUDY_DIRECTOR
References:
citation: 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.