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Effect of Food SupplementNCT05457218

Effect of Insect-derived Protein Supplements on Protein Synthesis and mTORC1 Activation

A study testing Whey protein, IPC80 and Whole Buffalo Powder in people with Effect of Food Supplement, run by University of California, Davis at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 30 yearsHealthy volunteers can take part
Conditions the study is for
Effect of Food Supplement
What is being tested?
Whey protein, IPC80 and Whole Buffalo Powder
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
1 Oct 2022to 30 Sep 2024
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
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Hickey Laboratory

    Davis, California, 95616

Other trials in United States

About this study

Official title: The Ability of Insect-derived Protein Supplements (IPC80 and Whole Buffalo Powder, Ynsect®) to Activate mTORC1 and Protein Synthesis in Muscle

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.

Read the detailed description

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.

It is expected that this project will determine whether insect-derived protein supplements (IPC80 and Whole Buffalo Powder, Ynsect®) have the ability to induce activation of the mTORC1 pathway and protein synthesis in muscle cells. Results from this study will give further insight into the usage of this novel sustainable protein source to support muscle protein synthesis after exercise.

Male and female participants between the ages of 18-30 years of age will be enrolled in the study. The study is a randomized double-blind crossover design with neither the subjects nor the investigators knowing who is on which treatment (IPC80, Whole Buffalo Powder or Whey).

  1. Baseline blood draw The subjects will arrive in the laboratory following an overnight fast. The antecubital vein will be cannulated, and an initial 5 mL baseline blood sample will be collected.

II. Supplementation After baseline blood draw, subjects will be provided with a supplement, 0.25 g/kg body weight of either whey protein, IPC80 or Whole Buffalo Powder dissolved in 250ml of water.

III. Postprandial blood draws Following consumption of the supplement, the participants will remain in the laboratory for another 1.5 hours, they may bring books or electronic devices to pass the time. Four more blood samples of 5 mL each will be obtained at 15, 30, 60, and 90 minutes after supplementation, totaling five blood draws of 5mL per visit (25mL per visit), and 75 mL of blood drawn in total for each subject completing the entire study.

Blood will be collected in 5 mL serum separating tubes. All blood samples will be allowed to clot for 1hr before centrifugation at 1000 x g for 10 minutes and the serum will be frozen and kept at -30°C until processed. Treatments will be randomized to avoid an order effect and a washout period of at least 48h between trials will be used to minimize the effect of the previous treatment.

To determine protein synthesis, we have stably transfected C2C12 muscle cells with a plasmid (pcDNA3 luciferase) that we use to measure global protein synthesis. 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; 80% Hank's buffered salt solution (HBSS)) for 15 minutes. Fasted muscle cells will then be treated with Test Media containing 0, 2.5, 5, or 10% baseline or fed serum for 60 minutes. Cells will be collected in passive lysis buffer and firefly luciferase activity will be determined as described previously (Philp et al., 2013).

To determine the ability of a protein source to activate mTORC1 we have stably transfected C2C12 muscle cells with a plasmid (pcDNA3-TOP luciferase) where the luciferase mRNA contains a 5' terminal polypyrimidine tract (TOP). 5'TOP mRNA are specifically regulated by mTORC1 activity (Jefferies et al., 1994). As above, differentiated C2C12TOPLuc muscle cells in 24-well plates will be stimulated using the baseline or fed serum as described above. The degree of mTORC1 activation will be determined as the difference in slopes between the baseline and fed sera. The induction of mTORC1 and protein synthesis by whey and IPC80 and Whole Buffalo Powder will be compared directly within individuals and then across groups.

Being tested
Whey protein, IPC80, Whole Buffalo Powder
Keywords
Protein synthesis, Protein supplement, mTORC1 activity, Insect-derived protein

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Whey proteinDietary supplement

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

  • IPC80Dietary supplement

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

  • Whole Buffalo PowderDietary supplement

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

Study groups in NCT05457218
Study groupRoleWhat they receive
Whey proteinExperimentalThis arm will be given a supplemental dose of whey protein (0.25 g/kg body weight)
Receives: Dietary Supplement: Whey protein
IPC80ExperimentalThis arm will be given a supplemental dose of IPC80, an insect-derived protein source (0.25 g/kg body weight)
Receives: Dietary Supplement: IPC80
Whole Buffalo PowderExperimentalThis arm will be given a supplemental dose of Whole Buffalo Powder, an insect-derived protein source (0.25 g/kg body weight)
Receives: Dietary Supplement: Whole Buffalo Powder

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline (0 hour) to 15 minutes after supplementation

  2. 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.

    Measured: Baseline (0 hour) to 30 minutes after supplementation

  3. 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.

    Measured: Baseline (0 hour) to 60 minutes after supplementation

  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.

    Measured: Baseline (0 hour) to 90 minutes after supplementation

Secondary outcomes (4)
  1. mTORC1 activity

    To measure the ability of a protein source (whey protein, IPC80 or Whole Buffalo Powder) to activate mTORC1, stably transfected C2C12 muscle cells with a plasmid (pcDNA3-TOP luciferase) where the luciferase mRNA contains a 5'TOP. 5'TOP mRNA , which specifically regulated by mTORC1 activity, will be used. Differentiated C2C12TOPLuc muscle cells in 24-well plates will be stimulated using the baseline or fed serum (rom blood samples at 15, 30, 60, and 90 minutes after supplementation). The degree of mTORC1 activation will be determined as the difference in slopes between the baseline and fed sera.

    Measured: Baseline (0 hour) to 15 minutes after supplementation

  2. mTORC1 activity

    To measure the ability of a protein source (whey protein, IPC80 or Whole Buffalo Powderl) to activate mTORC1, stably transfected C2C12 muscle cells with a plasmid (pcDNA3-TOP luciferase) where the luciferase mRNA contains a 5'TOP. 5'TOP mRNA , which specifically regulated by mTORC1 activity, will be used. Differentiated C2C12TOPLuc muscle cells in 24-well plates will be stimulated using the baseline or fed serum (rom blood samples at 15, 30, 60, and 90 minutes after supplementation). The degree of mTORC1 activation will be determined as the difference in slopes between the baseline and fed sera.

    Measured: Baseline (0 hour) to 30 minutes after supplementation

  3. mTORC1 activity

    To measure the ability of a protein source (whey protein, IPC80 or Whole Buffalo Powder) to activate mTORC1, stably transfected C2C12 muscle cells with a plasmid (pcDNA3-TOP luciferase) where the luciferase mRNA contains a 5'TOP. 5'TOP mRNA , which specifically regulated by mTORC1 activity, will be used. Differentiated C2C12TOPLuc muscle cells in 24-well plates will be stimulated using the baseline or fed serum (rom blood samples at 15, 30, 60, and 90 minutes after supplementation). The degree of mTORC1 activation will be determined as the difference in slopes between the baseline and fed sera.

    Measured: Baseline (0 hour) to 60 minutes after supplementation

  4. mTORC1 activity

    To measure the ability of a protein source (whey protein, IPC80 or Whole Buffalo Powder) to activate mTORC1, stably transfected C2C12 muscle cells with a plasmid (pcDNA3-TOP luciferase) where the luciferase mRNA contains a 5'TOP. 5'TOP mRNA , which specifically regulated by mTORC1 activity, will be used. Differentiated C2C12TOPLuc muscle cells in 24-well plates will be stimulated using the baseline or fed serum (rom blood samples at 15, 30, 60, and 90 minutes after supplementation). The degree of mTORC1 activation will be determined as the difference in slopes between the baseline and fed sera.

    Measured: Baseline (0 hour) to 90 minutes after supplementation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2022
  2. Study start1 Oct 2022
  3. Primary completion30 Jun 2023
  4. Study completion30 Sep 2024

Resources

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
Other
Allocation
Randomised
Intervention model
Crossover
Model description
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.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05457218
Sponsor's protocol ID
220601
Status last verified
May 2026
First submitted
6 Jul 2022
Last updated
8 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 24146969
  • 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.

    PubMed 8183928

Questions about this trial

What is this clinical trial studying?

A study testing Whey protein, IPC80 and Whole Buffalo Powder in people with Effect of Food Supplement, run by University of California, Davis at 1 site in United States.

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 8 May 2026. 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 United States. 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. 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?

Muscle protein synthesis (time frame: Baseline (0 hour) to 15 minutes after supplementation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05457218, which also lists 2 linked publications.

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 8 May 2026.

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