Marine Protein Hydrolysate as Dietary Supplement in Elderly Part II

Healthy Volunteers Clinical Trial

— MPH-DR  

Official title:

Dose Range Finding Study for Effects of Marine Protein Hydrolysate as Dietary Supplement in Elderly Active Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03526744
• Other study ID #: 2017/1795
• Status: Completed
• Phase: N/A
• Start date: April 27, 2018
• Est. completion date: November 14, 2018

Study information

• Verified date: February 2020
• 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 different doses of MPH supplement on glucose metabolism, hunger and appetite hormones.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 14, 2018
• Est. primary completion date: November 14, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Dietary Supplement:
• marine 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."
• marine 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."
• marine 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."
• marine 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."

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 (1)

Jensen C, Dale HF, Hausken T, Lied E, Hatlebakk JG, Brønstad I, Lied GA, Hoff DAL. Supplementation with cod protein hydrolysate in older adults: a dose range cross-over study. J Nutr Sci. 2019 Dec 4;8:e40. doi: 10.1017/jns.2019.37. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose	Postprandial glucose (mmol/L) curve on day 7 in each sequence	A standardized meal, thereafter repeated measures every 20 minutes for 2 hours on day 7 in each intervention sequence
Secondary	Insulin	Postprandial Insulin (mIE/L) - curve on day 7 in each sequence	After the standardized breakfast meal, repeated measure every 20 minutes for 2 hours, on day 7 in each intervention sequence
Secondary	Hormon 1	Glucagon like peptide 1 (GLP-1) pmol/l - curve, on day 7 in each sequence	At 6 different times point during a 2 hours period, on day 7 in each intervention sequence
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.	Before breakfast on each study day (day 7 in each intervention sequence)
Secondary	KANE, symptom score	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.	Two hours after breakfast on day 1 and 7 in each intervention sequence

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