Marine Protein Hydrolysate as Dietary Supplement in Elderly Part I

Helse Møre og Romsdal HF41 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Healthy Volunteers

Interventions

Marine protein hydrolysate (mph)DIETARY_SUPPLEMENT

Marine (Cod) protein hydrolysate

ControlDIETARY_SUPPLEMENT

Maltodextrin/Casein

Eligibility

Sex: ALLMin age: 40 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Ålesund Hospital, Helse Møre og Romsdal HF

Ålesund, Norway

Haukeland University Hospital

Bergen, Norway

Outcomes

Primary Outcomes

Glucose

Postprandial glucose (mmol/L) change on each day of intervention

Time frame: 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

Insulin

Postprandial Insulin (mIE/L) - change on each day of intervention

Time frame: 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

Hormon 1

Glucagon like peptide 1 (GLP-1) pmol/l change on each day of intervention

Time frame: First sample fasting baseline, thereafter repeated samples (i.e.20, 40, 60, 100 minutes after baseline), last at 200 minutes after baseline

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.

Time frame: 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

KANE, symptom score

Assessed by questionaire KANE (family name) , 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.

Time frame: First (baseline) symptom score (as described above) measured fasting and the next measure at 200 minutes after baseline

Data from ClinicalTrials.gov

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