Human NutritionKRILLNCT04864769
Effect of Intake of Hydrolyzed Krill Protein Isolate on Plasma Amino Acid Profile
A study testing Krill protein hydrolysate, Soy protein isolate and Whey protein isolate in people with Human Nutrition, run by Mette Hansen at 1 site in Denmark.
Trial summary
Purpose: To examine the absorption of three different protein sources: hydrolyzed krill protein isolate, whey protein isolate, and soy protein isolate. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Human Nutrition
- What is being tested?
- Krill protein hydrolysate, Soy protein isolate and Whey protein isolate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2019to 1 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- men
- 18-30 years
Who cannot join
- smoking,
- medication,
- health issues conflicting with the experimental trial
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Aarhus University, Department for Public Health, Section for Sport Science
Aarhus, 8000
About this study
Official title: 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.
Read the 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.
- Conditions
- Human Nutrition
- Being tested
- Krill protein hydrolysate, Soy protein isolate, Whey protein isolate, Water
- Keywords
- Protein, Amino Acids, Krill, Whey, Soy, Satiety, Insulin
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Krill protein hydrolysateDietary supplement
Ingestion of 35 g Krill protein hydrolysate
Soy protein isolateDietary supplement
Ingestion of 35 g Soy protein isolate
Whey protein isolateDietary supplement
Ingestion of 35 g Whey protein isolate
WaterDietary supplement
Ingestion of water (control)
| Study group | Role | What they receive |
|---|---|---|
| Krill Protein Hydrolysate | Experimental | Krill Protein Hydrolysate Receives: Dietary Supplement: Krill protein hydrolysate |
| Soy protein isolate | Active comparator | Soy Protein isolate Receives: Dietary Supplement: Soy protein isolate |
| Whey protein isolate | Active comparator | Whey protein isolate Receives: Dietary Supplement: Whey protein isolate |
| Control | Sham comparator | Water Receives: Dietary Supplement: Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amino acids concentrations
Measurement of changes in amino acids concentrations in the blood
Measured: 10 minutes prior to supplement up to 180 minutes after supplement
Secondary outcomes (2)
Visual Analogue Scale (VAS)
Measurements of changes in Hunger and satiety using 100 mm Visual Analogue Scores
Measured: 10 minutes prior to supplement up to 180 minutes after supplement
Insulin
Changes in serum insulin
Measured: 10 minutes prior to supplement up to 180 minutes after supplement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start1 Nov 2019
- Primary completion1 Jun 2020
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human NutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Model 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.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mette Hansen
- Sponsor type
- University, hospital or other
- Collaborators
- Aker BioMarine Human Ingredients AS
- Responsible party
- Sponsor-investigator, Mette Hansen, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04864769
- Sponsor's protocol ID
- Krill Protein
- Acronym
- KRILL
- Status last verified
- Apr 2021
- First submitted
- 13 Apr 2021
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intake of Hydrolyzed Krill Protein Isolate, Whey Protein Isolate and Soy Protein Isolate on Plasma Amino Acid Profile
- ClinicalTrials.gov ID
- NCT04864769
- Acronym / sponsor ID
- KRILL / Krill Protein
- Conditions
- Human Nutrition
- Keywords
- Protein, Amino Acids, Krill, Whey, Soy, Satiety, Insulin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mette HansenUniversity, hospital or other
- Collaborators
- Aker BioMarine Human Ingredients AS
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 29 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose: To examine the absorption of three different protein sources: hydrolyzed krill protein isolate, whey protein isolate, and soy protein isolate.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
- Model 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.
| Arm | Type | Receives |
|---|---|---|
| Krill Protein Hydrolysate | Experimental | Dietary Supplement: Krill protein hydrolysateKrill Protein Hydrolysate |
| Soy protein isolate | Active comparator | Dietary Supplement: Soy protein isolateSoy Protein isolate |
| Whey protein isolate | Active comparator | Dietary Supplement: Whey protein isolateWhey protein isolate |
| Control | Sham comparator | Dietary Supplement: WaterWater |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- men
- 18-30 years
Key exclusion criteria (3 listed)
- smoking,
- medication,
- health issues conflicting with the experimental trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Krill protein hydrolysateIngestion of 35 g Krill protein hydrolysate | Dietary supplement | Krill Protein Hydrolysate |
| Soy protein isolateIngestion of 35 g Soy protein isolate | Dietary supplement | Soy protein isolate |
| Whey protein isolateIngestion of 35 g Whey protein isolate | Dietary supplement | Whey protein isolate |
| WaterIngestion of water (control) | Dietary supplement | Control |
Primary outcome
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
2 secondary outcomes
Visual Analogue Scale (VAS)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Krill protein hydrolysate, Soy protein isolate and Whey protein isolate in people with Human Nutrition, run by Mette Hansen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amino acids concentrations (time frame: 10 minutes prior to supplement up to 180 minutes after supplement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2021.