Effect of Intake of Hydrolyzed Krill Protein Isolate on Plasma Amino Acid Profile (KRILL)

April 28, 2021 updated by: Mette Hansen

Effect of Intake of Hydrolyzed Krill Protein Isolate, Whey Protein Isolate and Soy Protein Isolate on Plasma Amino Acid Profile

Purpose: To examine the absorption of three different protein sources: hydrolyzed krill protein isolate, whey protein isolate, and soy protein isolate.

Study Overview

Detailed Description

Design and Method: Randomized, controlled, double-blind cross-study, in which 12 healthy adult young men in randomized order ingest 35 g of protein of crude protein from one of the three protein sources or water on four different experimental days. Before and up to three hours after ingestion of the test beverage, blood samples are collected for 8 time points during each experimental day.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Aarhus, Denmark, 8000
        • Aarhus University, Department for Public Health, Section for Sport Science

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • men
  • 18-30 years

Exclusion Criteria:

  • smoking,
  • medication,
  • health issues conflicting with the experimental trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Control
Water
Ingestion of water (control)
Experimental: Krill Protein Hydrolysate
Ingestion of 35 g Krill protein hydrolysate
Active Comparator: Soy protein isolate
Soy Protein isolate
Ingestion of 35 g Soy protein isolate
Active Comparator: Whey protein isolate
Ingestion of 35 g Whey protein isolate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amino acids concentrations
Time Frame: 10 minutes prior to supplement up to 180 minutes after supplement
Measurement of changes in amino acids concentrations in the blood
10 minutes prior to supplement up to 180 minutes after supplement

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale (VAS)
Time Frame: 10 minutes prior to supplement up to 180 minutes after supplement
Measurements of changes in Hunger and satiety using 100 mm Visual Analogue Scores
10 minutes prior to supplement up to 180 minutes after supplement
Insulin
Time Frame: 10 minutes prior to supplement up to 180 minutes after supplement
Changes in serum insulin
10 minutes prior to supplement up to 180 minutes after supplement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2019

Primary Completion (Actual)

June 1, 2020

Study Completion (Actual)

January 1, 2021

Study Registration Dates

First Submitted

April 13, 2021

First Submitted That Met QC Criteria

April 28, 2021

First Posted (Actual)

April 29, 2021

Study Record Updates

Last Update Posted (Actual)

April 29, 2021

Last Update Submitted That Met QC Criteria

April 28, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • Krill Protein

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data will be available by contacting the corresponding author up to five years after publication. However, before reuse an acceptance from the participants for reuse is mandatory.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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