Clinical trial NCT03669796: Marine Protein Hydrolysate as Dietary Supplement in Elderly Part I
Official title: A Study of the Effects of Marine Protein Hydrolysate as Dietary Supplement on the Regulation of Postprandial Blood Glucose Metabolism in Healthy 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: 2018-09-13
Enrollment: 41
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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 purpose: BASIC_SCIENCE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Glucose
timeFrame: First sample fasting baseline, thereafter repeated samples every 20 minutes (i.e.20, 40, 60, 80, 100,120,140 minutes after baseline), last at 200 minutes after baseline.
Secondary outcomes:
measure: Insulin
timeFrame: First sample fasting baseline, thereafter repeated samples every 20 minutes (i.e.20, 40, 60, 80, 100,120,140 minutes after baseline), last at 200 minutes after baseline
measure: Hormon 1
timeFrame: First sample fasting baseline, thereafter repeated samples (i.e.20, 40, 60, 100 minutes after baseline), last at 200 minutes after baseline
measure: Visual analogue scale (VAS)
timeFrame: First (baseline) symptomscore (as described above) measured fasting , thereafter repeated symptom score i.e. at 20, 40 minutes after baseline, last symptom score measure at 200 minutes after baseline
measure: KANE, symptom score
timeFrame: First (baseline) symptom score (as described above) measured fasting and the next measure at 200 minutes after baseline
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: Møre & Romsdal Hospital Trust, Ålesund Hospital
name: Dag Arne Lihaug Hoff, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.