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 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.
Interventions
DIETARY_SUPPLEMENTmarine protein hydrolysate 1234
Dietary Supplement for e.g. in this order: MPH 1600 mg for 7 days, than 7 days wash-out. Dietary Supplement: MPH 800 mg for 7 days, than 7 days wash-out. Dietary Supplement: MPH 2400 mg for 7 days, than 7 days wash-out. Dietary Supplement: MPH 3200 mg for 7 days, than 7 days wash-out.
DIETARY_SUPPLEMENTmarine protein hydrolysate 2134
Dietary Supplement for e.g. in this order: MPH 3200 mg for 7 days, than 7 days wash-out. Dietary Supplement: MPH 800 mg for 7 days, than 7 days wash-out. Dietary Supplement: MPH 2400 mg for 7 days, than 7 days wash-out. Dietary Supplement: MPH 1600 mg for 7 days, than 7 days wash-out.
DIETARY_SUPPLEMENTmarine protein hydrolysate 3124
Dietary Supplement for e.g. in this order: MPH 2400 mg for 7 days, than 7 days wash-out. Dietary Supplement: MPH 3200 mg for 7 days, than 7 days wash-out. Dietary Supplement: MPH 1600 mg for 7 days, than 7 days wash-out. Dietary Supplement: MPH 800 mg for 7 days, than 7 days wash-out.
DIETARY_SUPPLEMENTmarine protein hydrolysate 4123
Dietary Supplement for e.g. in this order: MPH 1600 mg for 7 days, than 7 days wash-out. Dietary Supplement: MPH 800 mg for 7 days, than 7 days wash-out. Dietary Supplement: MPH 3200 mg for 7 days, than 7 days wash-out. Dietary Supplement: MPH 2400 mg for 7 days, than 7 days wash-out.
Sponsors
Haukeland University Hospital
Helse Møre og Romsdal HF
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
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.
Eligibility
Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glucose | A standardized meal, thereafter repeated measures every 20 minutes for 2 hours on day 7 in each intervention sequence | Postprandial glucose (mmol/L) curve on day 7 in each sequence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insulin | After the standardized breakfast meal, repeated measure every 20 minutes for 2 hours, on day 7 in each intervention sequence | Postprandial Insulin (mIE/L) - curve on day 7 in each sequence |
| Hormon 1 | At 6 different times point during a 2 hours period, on day 7 in each intervention sequence | Glucagon like peptide 1 (GLP-1) pmol/l - curve, on day 7 in each sequence |
| Visual analogue scale (VAS) | Before breakfast on each study day (day 7 in each intervention sequence) | 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 | Two hours after breakfast on day 1 and 7 in each intervention sequence | Assessed by questionaire KANE (Family name of an Author) , 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