NCT04633694

Brief Summary

Randomized parallel study investing the effect of intake of different protein sources (whey, insect and pea) on the muscle protein synthesis. Activation of the signaling pathway leading to muscle protein synthesis is investigated by western blotting and Real time quantitative polymerase chain reaction (qPCR or PCR). Urine, blood and muscle is moreover investigated by metabolomics analysis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2020

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 18, 2020

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 8, 2023

Completed
Last Updated

May 31, 2024

Status Verified

May 1, 2024

Enrollment Period

6 months

First QC Date

August 10, 2020

Last Update Submit

May 30, 2024

Conditions

Sarcopenia

Keywords

mTORC metabolomics,Western blottingReal time quantitative polymerase chain reactionNuclear magnetic resonanceLiquid chromatography-mass spectrometry

Outcome Measures

Primary Outcomes (3)

  • Expression and phosphorylation of signaling proteins and their mRNA by Western Blotting and PCR

    Change in expression and phosphorylation of signaling proteins and the mRNA related the muscle protein synthesis.

    4 hours

  • Blod and urine metabolism by NMR

    Both blod and urine are analysed by nuclear magnetic resonance (NMR) metabolomics to enlighten changes in the metabolites.

    4 hours

  • Muscle metabolism by NMR

    The muscle metabolites are quantified before intervention, after protein and after protein end exercise.

    3 hours

Secondary Outcomes (5)

  • BMI

    1 hour

  • General physical activity

    3 months

  • Blood glucose

    4 hours

  • Blood Insulin

    4 hours

  • Food intake, calories and distribution of macro nutrients.

    1 day

Study Arms (3)

Insect protein

EXPERIMENTAL

The participants are are given insect protein

Dietary Supplement: insect, pea or whey protein

Pea protein

EXPERIMENTAL

The participants are are given pea protein

Dietary Supplement: insect, pea or whey protein

Whey protein

EXPERIMENTAL

The participants are are given whey protein

Dietary Supplement: insect, pea or whey protein

Interventions

insect, pea or whey proteinDIETARY_SUPPLEMENT

The protein powder is dissolved in 400 mL water and given relative to lean body mass, 0.25 g protein pr kg lean body mass.

Insect proteinPea proteinWhey protein

Eligibility Criteria

Age18 Years - 30 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsBiological males
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • male
  • year
  • able to read and understand danish

You may not qualify if:

  • smoking
  • resistance training more than 1 time pr month
  • endurance training more than 2 hours pr week
  • Allergy toward shellfish, house dust mites or the protein sources.
  • knee problems effecting the exercise
  • weight change more than 5 kg the last half year
  • medicine which can effect the protein turnover
  • Disease in joint, or muscle as well as metabolic diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Public Health,

Aarhus, 8000, Denmark

Location

Related Publications (1)

  • Lanng SK, Oxfeldt M, Pedersen SS, Johansen FT, Risikesan J, Lejel T, Bertram HC, Hansen M. Influence of protein source (cricket, pea, whey) on amino acid bioavailability and activation of the mTORC1 signaling pathway after resistance exercise in healthy young males. Eur J Nutr. 2023 Apr;62(3):1295-1308. doi: 10.1007/s00394-022-03071-y. Epub 2022 Dec 19.

    PMID: 36536114DERIVED

MeSH Terms

Conditions

Sarcopenia

Interventions

Whey Proteins

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Milk ProteinsAnimal Proteins, DietaryDietary ProteinsProteinsAmino Acids, Peptides, and ProteinsWheyMilkDairy ProductsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
The project leader are responsible for the masking while all other persons involved in the project do not know the protein source given.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A parallel 3 armed study, each arm with a different protein type
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2020

First Posted

November 18, 2020

Study Start

June 1, 2020

Primary Completion

November 30, 2020

Study Completion

November 8, 2023

Last Updated

May 31, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

All analysis will be performed within the research team.

Locations

DK(1)