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Completed

NCT Number: NCT03526744

Marine Protein Hydrolysate as Dietary Supplement in Elderly Part II

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

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Key information

Conditions

Healthy Volunteers

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haukeland University Hospital, Bergen, Norway

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

marine protein hydrolysate 1234

Dietary Supplement

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

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

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

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."

Primary outcomes

  1. Glucose

    Time frame: 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 outcomes

  1. Insulin

    Time frame: 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

  2. Hormon 1

    Time frame: 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

  3. Visual analogue scale (VAS)

    Time frame: 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.

  4. KANE, symptom score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Helse Møre og Romsdal HF

Other Gov

Collaborators

  • Haukeland University Hospital

Registry information

Official study title

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

Acronym: MPH-DR

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 16, 2018
Registry last updated
Feb 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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