Marine Protein Hydrolysate as Dietary Supplement in Elderly Part II (MPH-DR)

Helse Møre og Romsdal HF

Status: Completed

Conditions: Healthy Volunteers

Treatments: Dietary Supplement: marine protein hydrolysate 3124; Dietary Supplement: marine protein hydrolysate 4123; Dietary Supplement: marine protein hydrolysate 1234; Dietary Supplement: marine protein hydrolysate 2134

Study type: Interventional

Funder types: Other

Identifiers

NCT03526744

2017/1795

Details and patient eligibility

About

The aim of this study is to investigate the potential effect of different doses of MPH supplement on glucose metabolism, hunger and appetite hormones.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 60 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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30 participants in 4 patient groups

marine protein hydrolysate 1234

Experimental group

Description:

Daily intake at breakfast of supplementary marine protein hydrolysate (MPH) equivalent to 10, 20, 30 or 40 mg per kg bodyweight during 1 week, followed by 3 similar cycles with other MPH dosages, with up to 7 days wash-out in between. Random sequence of arms.

Treatment:

Dietary Supplement: marine protein hydrolysate 1234

marine protein hydrolysate 2134

Experimental group

Description:

Daily intake at breakfast of supplementary marine protein hydrolysate (MPH) equivalent to 10, 20, 30 or 40 mg per kg bodyweight during 1 week, followed by 3 similar cycles with other MPH dosages, with up to 7 days wash-out in between. Random sequence of arms.

Treatment:

Dietary Supplement: marine protein hydrolysate 2134

marine protein hydrolysate 3124

Experimental group

Description:

Daily intake at breakfast of supplementary marine protein hydrolysate (MPH) equivalent to 10, 20, 30 or 40 mg per kg bodyweight during 1 week, followed by 3 similar cycles with other MPH dosages, with with up to 7 days-out in between. Random sequence of arms.

Treatment:

Dietary Supplement: marine protein hydrolysate 3124

marine protein hydrolysate 4123

Experimental group

Description:

Daily intake at breakfast of supplementary marine protein hydrolysate (MPH) equivalent to 10, 20, 30 or 40 mg per kg bodyweight during 1 week, followed by 3 similar cycles with other MPH dosages, with up to 7 days wash-out in between. Random sequence of arms.

Treatment:

Dietary Supplement: marine protein hydrolysate 4123