Marine Protein Hydrolysate as Dietary Supplement in Elderly Part II

NCT03526744 | Completed

• 1 other identifier: 2017/1795
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy Volunteers

Keywords

Dietary Supplements; Fish Proteins; Protein Hydrolysates; Aged

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Insulin

  After the standardized breakfast meal, repeated measure every 20 minutes for 2 hours, on day 7 in each intervention sequence

• Hormon 1

  At 6 different times point during a 2 hours period, on day 7 in each intervention sequence

• Visual analogue scale (VAS)

  Before breakfast on each study day (day 7 in each intervention sequence)

• KANE, symptom score

  Two hours after breakfast on day 1 and 7 in each intervention sequence

Study Arms (4)

marine protein hydrolysate 1234

EXPERIMENTAL

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.

Dietary Supplement: marine protein hydrolysate 1234

marine protein hydrolysate 2134

EXPERIMENTAL

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.

Dietary Supplement: marine protein hydrolysate 2134

marine protein hydrolysate 3124

EXPERIMENTAL

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.

Dietary Supplement: marine protein hydrolysate 3124

marine protein hydrolysate 4123

EXPERIMENTAL

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.

Dietary Supplement: marine protein hydrolysate 4123

Interventions

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 1234

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 2134

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 3124

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."

marine protein hydrolysate 4123

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent
• Body mass index (BMI) 20-30 kg/m2

You may not qualify if:

• 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
• Substance misuse
• Inability or unwillingness to comply with the requirements of study procedures

Sponsors & Collaborators

• Helse Møre og Romsdal HF: lead
• Haukeland University Hospital: collaborator

Study Sites (2)

Ålesund Hospital, Helse Møre og Romsdal HF

Ålesund, Norway

Location

Haukeland University Hospital

Bergen, Norway

Location

Related Publications (1)

• Jensen C, Dale HF, Hausken T, Lied E, Hatlebakk JG, Bronstad 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.

  PMID: 32042407 RESULT

Related Links

• Related Info

Study Officials

• Dag Arne Lihaug Hoff, md phd

  Helse Møre & Romsdal HF, Ålesund Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 26, 2018
• First Posted: May 16, 2018
• Study Start: April 27, 2018
• Primary Completion: November 14, 2018
• Study Completion: November 14, 2018
• Last Updated: February 17, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

NO (2)