Healthy Volunteers
Conditions
Keywords
Dietary Supplements, Fish Proteins, Protein Hydrolysates, Aged
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.
Interventions
DIETARY_SUPPLEMENTMarine protein hydrolysate (mph)
Marine (Cod) protein hydrolysate
DIETARY_SUPPLEMENTControl
Maltodextrin/Casein
Sponsors
Haukeland University Hospital
Helse Møre og Romsdal HF
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
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).
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glucose | 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. | Postprandial glucose (mmol/L) change on each day of intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insulin | 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 | Postprandial Insulin (mIE/L) - change on each day of intervention |
| Hormon 1 | First sample fasting baseline, thereafter repeated samples (i.e.20, 40, 60, 100 minutes after baseline), last at 200 minutes after baseline | Glucagon like peptide 1 (GLP-1) pmol/l change on each day of intervention |
| Visual analogue scale (VAS) | 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 | 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 | First (baseline) symptom score (as described above) measured fasting and the next measure at 200 minutes after baseline | 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. |
Countries
Norway
Outcome results
None listed