- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04864769
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
Status
Completed
Conditions
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.
Sponsor
Collaborators
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
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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