NCT04864769

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 29, 2021

Completed
Last Updated

April 29, 2021

Status Verified

April 1, 2021

Enrollment Period

7 months

First QC Date

April 13, 2021

Last Update Submit

April 28, 2021

Conditions

Human Nutrition

Keywords

ProteinAmino AcidsKrillWheySoySatietyInsulin

Outcome Measures

Primary Outcomes (1)

  • Amino acids concentrations

    Measurement of changes in amino acids concentrations in the blood

    10 minutes prior to supplement up to 180 minutes after supplement

Secondary Outcomes (2)

  • Visual Analogue Scale (VAS)

    10 minutes prior to supplement up to 180 minutes after supplement

  • Insulin

    10 minutes prior to supplement up to 180 minutes after supplement

Study Arms (4)

Krill Protein Hydrolysate

EXPERIMENTAL

Krill Protein Hydrolysate

Dietary Supplement: Krill protein hydrolysate

Soy protein isolate

ACTIVE COMPARATOR

Soy Protein isolate

Dietary Supplement: Soy protein isolate

Whey protein isolate

ACTIVE COMPARATOR

Whey protein isolate

Dietary Supplement: Whey protein isolate

Control

SHAM COMPARATOR

Water

Dietary Supplement: Water

Interventions

Krill protein hydrolysateDIETARY_SUPPLEMENT

Ingestion of 35 g Krill protein hydrolysate

Krill Protein Hydrolysate
Soy protein isolateDIETARY_SUPPLEMENT

Ingestion of 35 g Soy protein isolate

Soy protein isolate
Whey protein isolateDIETARY_SUPPLEMENT

Ingestion of 35 g Whey protein isolate

Whey protein isolate
WaterDIETARY_SUPPLEMENT

Ingestion of water (control)

Control

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • men
  • years

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University, Department for Public Health, Section for Sport Science

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Insulin Resistance

Interventions

Soybean ProteinsWater

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Plant ProteinsProteinsAmino Acids, Peptides, and ProteinsPlant Proteins, DietaryDietary ProteinsFoodDiet, Food, and NutritionPhysiological PhenomenaSoy FoodsVegetable ProductsVegetablesFood and BeveragesHydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 13, 2021

First Posted

April 29, 2021

Study Start

November 1, 2019

Primary Completion

June 1, 2020

Study Completion

January 1, 2021

Last Updated

April 29, 2021

Record last verified: 2021-04

Locations

DK(1)