NCT05457218

Brief Summary

The purpose of this study is to determine the ability of insect-derived protein supplements (IPC80 and Whole Buffalo Powder Ynsect®) to activate the mTORC1 pathway and protein synthesis in muscle cells. To achieve this aim, participants will consume a supplemental dose (0.25 g/kg body weight) of IPC80,Whole Buffalo Powder or whey protein. Blood samples will be drawn before and 15, 30, 60 and 90 minutes after the supplementation. Protein synthesis will be assessed using stably transfected C2C12 muscle cells with a plasmid (pcDNA3 luciferase) and to determine the ability of a protein source to activate mTORC1, stably transfected C2C12 muscle cells with a plasmid (pcDNA3-TOP luciferase) where the luciferase mRNA contains a 5'TOP. 5'TOP which is specifically regulated by mTORC1 activity will be used.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2022

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 13, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

October 31, 2024

Status Verified

October 1, 2024

Enrollment Period

9 months

First QC Date

July 6, 2022

Last Update Submit

October 29, 2024

Conditions

Keywords

Protein synthesisProtein supplementmTORC1 activityInsect-derived protein

Outcome Measures

Primary Outcomes (4)

  • Muscle protein synthesis

    To measure muscle protein synthesis, stably transfected C2C12 muscle cells with a plasmid (pcDNA3 luciferase) will be used. C2C12Luc cells will be plated in 24-well plates and differentiated over 4 days. Differentiated C2C12 cells will be fasted by washing with PBS and then treating them with Test Media (20% DMEM) for 15 minutes. Fasted muscle cells will then be treated with Test Media containing 0, 2.5, 5, or 10% baseline or fed serum (from blood samples at 15, 30, 60, and 90 minutes after supplementation) for 60 minutes. Cells will be collected in passive lysis buffer and firefly luciferase activity will be determined.

    Baseline (0 hour) to 15 minutes after supplementation

  • Muscle protein synthesis

    To measure muscle protein synthesis, stably transfected C2C12 muscle cells with a plasmid (pcDNA3 luciferase) will be used. C2C12Luc cells will be plated in 24-well plates and differentiated over 4 days. Differentiated C2C12 cells will be fasted by washing with PBS and then treating them with Test Media (20% DMEM) for 15 minutes. Fasted muscle cells will then be treated with Test Media containing 0, 2.5, 5, or 10% baseline or fed serum (from blood samples at 15, 30, 60, and 90 minutes after supplementation) for 60 minutes. Cells will be collected in passive lysis buffer and firefly luciferase activity will be determined.

    Baseline (0 hour) to 30 minutes after supplementation

  • Muscle protein synthesis

    To measure muscle protein synthesis, stably transfected C2C12 muscle cells with a plasmid (pcDNA3 luciferase) will be used. C2C12Luc cells will be plated in 24-well plates and differentiated over 4 days. Differentiated C2C12 cells will be fasted by washing with PBS and then treating them with Test Media (20% DMEM) for 15 minutes. Fasted muscle cells will then be treated with Test Media containing 0, 2.5, 5, or 10% baseline or fed serum (from blood samples at 15, 30, 60, and 90 minutes after supplementation) for 60 minutes. Cells will be collected in passive lysis buffer and firefly luciferase activity will be determined.

    Baseline (0 hour) to 60 minutes after supplementation

  • Muscle protein synthesis

    To measure muscle protein synthesis, stably transfected C2C12 muscle cells with a plasmid (pcDNA3 luciferase) will be used. C2C12Luc cells will be plated in 24-well plates and differentiated over 4 days. Differentiated C2C12 cells will be fasted by washing with PBS and then treating them with Test Media (20% DMEM) for 15 minutes. Fasted muscle cells will then be treated with Test Media containing 0, 2.5, 5, or 10% baseline or fed serum (from blood samples at 15, 30, 60, and 90 minutes after supplementation) for 60 minutes. Cells will be collected in passive lysis buffer and firefly luciferase activity will be determined.

    Baseline (0 hour) to 90 minutes after supplementation

Secondary Outcomes (4)

  • mTORC1 activity

    Baseline (0 hour) to 15 minutes after supplementation

  • mTORC1 activity

    Baseline (0 hour) to 30 minutes after supplementation

  • mTORC1 activity

    Baseline (0 hour) to 60 minutes after supplementation

  • mTORC1 activity

    Baseline (0 hour) to 90 minutes after supplementation

Study Arms (3)

Whey protein

EXPERIMENTAL

This arm will be given a supplemental dose of whey protein (0.25 g/kg body weight)

Dietary Supplement: Whey protein

IPC80

EXPERIMENTAL

This arm will be given a supplemental dose of IPC80, an insect-derived protein source (0.25 g/kg body weight)

Dietary Supplement: IPC80

Whole Buffalo Powder

EXPERIMENTAL

This arm will be given a supplemental dose of Whole Buffalo Powder, an insect-derived protein source (0.25 g/kg body weight)

Dietary Supplement: Whole Buffalo Powder

Interventions

Whey proteinDIETARY_SUPPLEMENT

The participant will consume a supplemental dose of whey protein (0.25 g/kg body weight)

Whey protein
IPC80DIETARY_SUPPLEMENT

The participant will consume a supplemental dose of IPC80 (0.25 g/kg body weight)

IPC80
Whole Buffalo PowderDIETARY_SUPPLEMENT

The participant will consume a supplemental dose of Whole Buffalo Powder (0.25 g/kg body weight)

Whole Buffalo Powder

Eligibility Criteria

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

You may qualify if:

  • Healthy active male or female
  • Normal weight (BMI between 18 and 25 kg/m2)

You may not qualify if:

  • Receiving any medication that may interfere with the study.
  • Health or dietary restrictions that would be affected by the supplementation protocol.
  • Allergy to shellfish (the chitins in the mealworm exoskeleton can activate shellfish allergies)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hickey Laboratory

Davis, California, 95616, United States

Location

Related Publications (2)

  • Philp A, MacKenzie MG, Belew MY, Towler MC, Corstorphine A, Papalamprou A, Hardie DG, Baar K. Glycogen content regulates peroxisome proliferator activated receptor- partial differential (PPAR- partial differential) activity in rat skeletal muscle. PLoS One. 2013 Oct 17;8(10):e77200. doi: 10.1371/journal.pone.0077200. eCollection 2013.

    PMID: 24146969BACKGROUND
  • Jefferies HB, Reinhard C, Kozma SC, Thomas G. Rapamycin selectively represses translation of the "polypyrimidine tract" mRNA family. Proc Natl Acad Sci U S A. 1994 May 10;91(10):4441-5. doi: 10.1073/pnas.91.10.4441.

    PMID: 8183928BACKGROUND

MeSH Terms

Interventions

Whey Proteins

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Keith Baar, PhD

    UC Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
A randomized double-blind crossover design with neither the subjects nor the investigators knowing who is on which treatment. The interventions will be coded using a blinded alphabetical letter code (A, B, C). A delegate researcher (independent party not further involved in the study) will randomize all interventions using a computer-generated randomization list. The delegate will hand in the code-breaker to the principal investigator in a sealed envelope. The envelope will be stored in a locked filing cabinet in the principal investigator's office, which will also be locked when unoccupied. The envelope will be opened by the principal investigator after completing the analysis of blood samples.
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Participants will consume a supplemental dose (0.25 g/kg body weight) of either IPC80, Whole Buffalo Powder or whey protein. The type of consumed supplementation will be randomized where neither the participant nor investigator will know which supplement is being consumed. Each participant will repeat the protocol three times.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2022

First Posted

July 13, 2022

Study Start

October 1, 2022

Primary Completion

June 30, 2023

Study Completion

September 30, 2024

Last Updated

October 31, 2024

Record last verified: 2024-10

Locations