A Study of the Effects of Marine Protein Hydrolysate as Dietary Supplement on the Regulation of Postprandial Blood Glucose Metabolism in Healthy Subjects
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Helse Møre og Romsdal HF
- Enrollment
- 41
- Locations
- 2
- Primary Endpoint
- Glucose
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 40 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
supplementary Marine protein hydrolysate
20 mg powder per kg body weight of Marine protein hydrolysate (MPH)
Intervention: Marine protein hydrolysate (mph) (Dietary Supplement)
control
20 mg powder per kg body weight of casein/maltodextrin
Intervention: Control (Dietary Supplement)
Outcomes
Primary Outcomes
Glucose
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.
Postprandial glucose (mmol/L) change on each day of intervention
Secondary Outcomes
- 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)
- Hormon 1(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)(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(First (baseline) symptom score (as described above) measured fasting and the next measure at 200 minutes after baseline)