Marine Protein Hydrolysate as Dietary Supplement in Elderly Part I

Healthy Volunteers Clinical Trial

— MPH-BS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03669796
• Other study ID #: 2017/1794
• Status: Completed
• Phase: N/A
• Start date: November 27, 2017
• Est. completion date: February 28, 2018

Study information

• Verified date: November 2019
• Source: Helse Møre og Romsdal HF
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: February 28, 2018
• Est. primary completion date: February 28, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Dietary Supplement:
• Marine protein hydrolysate (mph)
Marine (Cod) protein hydrolysate
• Control
Maltodextrin/Casein

Locations

Country	Name	City	State
Norway	Ålesund Hospital, Helse Møre og Romsdal HF	Ålesund
Norway	Haukeland University Hospital	Bergen

Sponsors (2)

Lead Sponsor	Collaborator
Helse Møre og Romsdal HF	Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (3)

Dale HF, Jensen C, Hausken T, Lied E, Hatlebakk JG, Brønstad 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 crossov — View Citation

Dale HF, Jensen C, Hausken T, Lied E, Hatlebakk JG, Brønstad 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; — View Citation

Dale HF, Jensen C, Hausken T, Lied E, Hatlebakk JG, Brønstad 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: 10.10 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose	Postprandial glucose (mmol/L) change on each day of intervention	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	Insulin	Postprandial Insulin (mIE/L) - change on each day of intervention	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	Hormon 1	Glucagon like peptide 1 (GLP-1) pmol/l change on each day of intervention	First sample fasting baseline, thereafter repeated samples (i.e.20, 40, 60, 100 minutes after baseline), last at 200 minutes after baseline
Secondary	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.	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
Secondary	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.	First (baseline) symptom score (as described above) measured fasting and the next measure at 200 minutes after baseline