AminoacidemiaNCT04719429
The Effects of Cricket- and Beef-derived Protein on Plasma Amino Acid Concentrations and Appetite Responses
A study testing Cricket-derived Protein and Beef-derived Protein in people with Aminoacidemia and Appetitive Behavior, run by McGill University at 1 site in Canada.
Trial summary
Dietary protein plays an important role in appetite regulation. Source of ingested dietary protein may have different effects on appetite, satiety, and/or food intake in humans. Insects are a rich source of protein consumed by many people around the world; however, the capacity of insect-derived protein to regulate… Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Aminoacidemia, Appetitive Behavior
- What is being tested?
- Cricket-derived Protein and Beef-derived Protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 28 Jan 2019to 9 Apr 2019
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- Aged between 18-35 years inclusive
- Healthy, moderately active
- BMI < 30 kg/m2 and > 18.5 kg/m2
- Having given informed consent
Who cannot join
- Presence of any identified metabolic or intestinal disorders
- Use of tobacco products
- Adherence to a strict vegetarian or vegan diet
- Use of medications known to affect protein metabolism
- Allergy to shellfish or crustaceans
- Allergy to beef protein
- Engagement in physical exercise training more than 6 days per week
Trial locations and contacts
1 site in 1 country.
Canada1 site
Exercise Metabolism and Nutrition Research Laboratory
Montreal, Quebec, H2W 1S4
About this study
Official title: The Effects of Dietary Protein Source on Postprandial Plasma Amino Acid Availability, Gut-derived Appetite Regulating Hormones, and Subjective Appetite Sensations in Young Males
Dietary protein plays an important role in appetite regulation. Source of ingested dietary protein may have different effects on appetite, satiety, and/or food intake in humans. Insects are a rich source of protein consumed by many people around the world; however, the capacity of insect-derived protein to regulate appetite and food intake is unclear. The purpose of this study was to compare postprandial plasma glucose, insulin, amino acid, and appetite regulatory hormone concentrations, subjective appetite sensations, and food intake following the ingestion of 25 g of cricket- and beef-derived protein in healthy young males.
Read the detailed description
With the rapid increase in the global population, the production of sufficient amounts of conventional animal-based protein to meet global dietary demands may no longer be desired nor feasible. Insects may represent an environmentally sustainable additional source of dietary protein that has the potential to help ensure global food security in the future. However, the functional characteristics of insect-derived proteins when fed to humans is unclear. Further, how insect-derived proteins compare to other animal-derived proteins (e.g. from beef) have not been explored.
The purpose of this study was to compare postprandial plasma glucose, insulin, and amino acid concentrations, gut-derived appetite regulatory hormones, subjective appetite sensations, and ad libitum energy intake following the ingestion of 25 g insect- or beef-derived protein in healthy young men. It was hypothesized that hyperaminoacidaemia would be more rapid following the ingestion of beef-derived protein compared to cricket-derived protein, although total amino acid availability would be similar between protein sources over a 300-minute postprandial period. It was further hypothesized there would be no difference between protein sources on postprandial subjective appetite sensations or subsequent ad libitum energy intake.
- Conditions
- Aminoacidemia, Appetitive Behavior
- Being tested
- Cricket-derived Protein, Beef-derived Protein
- Keywords
- dietary protein, insect protein, young men, beef collagen, amino acids, appetite
- Medical subject headings
- Appetitive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cricket-derived ProteinDietary supplement
Beverage containing 25 g cricket-derived protein
Beef-derived ProteinDietary supplement
Beverage containing 25 g beef-derived protein
| Study group | Role | What they receive |
|---|---|---|
| Cricket-derived protein beverage | Experimental | Ingestion of a cricket-derived protein beverage Receives: Dietary Supplement: Cricket-derived Protein |
| Beef-derived protein beverage | Experimental | Ingestion of a beef-derived protein beverage Receives: Dietary Supplement: Beef-derived Protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma leucine concentration
umol/L
Measured: 0-5 hours in the post-prandial period
Subjective appetite sensations (hunger, fullness, desire to eat, prospective food consumption)
mm (visual analogue scale)
Measured: 0-5 hours in the post-prandial period
Secondary outcomes (9)
Plasma branched-chain amino acid concentration
umol/L
Measured: 0-5 hours in the post-prandial period
Plasma essential amino acid concentration
umol/L
Measured: 0-5 hours in the post-prandial period
Plasma non-essential amino acid concentration
umol/L
Measured: 0-5 hours in the post-prandial period
Plasma total amino acid concentration
umol/L
Measured: 0-5 hours in the post-prandial period
Plasma glucose
mmol/L
Measured: 0-5 hours in the post-prandial period
Plasma insulin
pmol/L
Measured: 0-5 hours in the post-prandial period
Plasma GLP-1
pg/mL
Measured: 0-5 hours in the post-prandial period
Plasma PYY
pg/mL
Measured: 0-5 hours in the post-prandial period
Ad libitum food energy intake
kJ
Measured: assessed 5 hours after protein intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start28 Jan 2019
- Primary completion9 Apr 2019
- Study completion9 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AminoacidemiaStudies 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tyler Churchward-Venne, McGill University
- Investigators
- Tyler A Churchward-Venne, Ph.D., Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04719429
- Sponsor's protocol ID
- A08-M28-18B
- Status last verified
- Jan 2021
- First submitted
- 15 Jan 2021
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Dietary Protein Source on Postprandial Plasma Amino Acid Availability, Gut-derived Appetite Regulating Hormones, and Subjective Appetite Sensations in Young Males
- ClinicalTrials.gov ID
- NCT04719429
- Acronym / sponsor ID
- A08-M28-18B
- Conditions
- Aminoacidemia, Appetitive Behavior
- Keywords
- dietary protein, insect protein, young men, beef collagen, amino acids, appetite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Study start
- 28 Jan 2019 (actual)
- Primary completion
- 9 Apr 2019 (actual)
- Study completion
- 9 Apr 2019 (actual)
- First posted
- 22 Jan 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.
Dietary protein plays an important role in appetite regulation. Source of ingested dietary protein may have different effects on appetite, satiety, and/or food intake in humans. Insects are a rich source of protein consumed by many people around the world; however, the capacity of insect-derived protein to regulate appetite and food intake is unclear. The purpose of this study was to compare postprandial plasma glucose, insulin, amino acid, and appetite regulatory hormone concentrations, subjective appetite sensations, and food intake following the ingestion of 25 g of cricket- and beef-derived protein in healthy young males.
Detailed description
With the rapid increase in the global population, the production of sufficient amounts of conventional animal-based protein to meet global dietary demands may no longer be desired nor feasible. Insects may represent an environmentally sustainable additional source of dietary protein that has the potential to help ensure global food security in the future. However, the functional characteristics of insect-derived proteins when fed to humans is unclear. Further, how insect-derived proteins compare to other animal-derived proteins (e.g. from beef) have not been explored.
The purpose of this study was to compare postprandial plasma glucose, insulin, and amino acid concentrations, gut-derived appetite regulatory hormones, subjective appetite sensations, and ad libitum energy intake following the ingestion of 25 g insect- or beef-derived protein in healthy young men. It was hypothesized that hyperaminoacidaemia would be more rapid following the ingestion of beef-derived protein compared to cricket-derived protein, although total amino acid availability would be similar between protein sources over a 300-minute postprandial period. It was further hypothesized there would be no difference between protein sources on postprandial subjective appetite sensations or subsequent ad libitum energy intake.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cricket-derived protein beverage | Experimental | Dietary Supplement: Cricket-derived ProteinIngestion of a cricket-derived protein beverage |
| Beef-derived protein beverage | Experimental | Dietary Supplement: Beef-derived ProteinIngestion of a beef-derived protein beverage |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male
- Aged between 18-35 years inclusive
- Healthy, moderately active
- BMI < 30 kg/m2 and > 18.5 kg/m2
- Having given informed consent
Key exclusion criteria (7 listed)
- Presence of any identified metabolic or intestinal disorders
- Use of tobacco products
- Adherence to a strict vegetarian or vegan diet
- Use of medications known to affect protein metabolism
- Allergy to shellfish or crustaceans
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 |
|---|---|---|
| Cricket-derived ProteinBeverage containing 25 g cricket-derived protein | Dietary supplement | Cricket-derived protein beverage |
| Beef-derived ProteinBeverage containing 25 g beef-derived protein | Dietary supplement | Beef-derived protein beverage |
Primary outcome
Plasma leucine concentration
Time frame: 0-5 hours in the post-prandial period
umol/L
Subjective appetite sensations (hunger, fullness, desire to eat, prospective food consumption)
Time frame: 0-5 hours in the post-prandial period
mm (visual analogue scale)
9 secondary outcomes
Plasma branched-chain amino acid concentration
Time frame: 0-5 hours in the post-prandial period
Plasma essential amino acid concentration
Time frame: 0-5 hours in the post-prandial period
Plasma non-essential amino acid concentration
Time frame: 0-5 hours in the post-prandial period
Plasma total amino acid concentration
Time frame: 0-5 hours in the post-prandial period
Plasma glucose
Time frame: 0-5 hours in the post-prandial period
Plasma insulin
Time frame: 0-5 hours in the post-prandial period
Plasma GLP-1
Time frame: 0-5 hours in the post-prandial period
Plasma PYY
Time frame: 0-5 hours in the post-prandial period
Ad libitum food energy intake
Time frame: assessed 5 hours after protein intake
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 22 Jan 2021.
- Individual participant dataSharing planned: No
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Nutrition
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.
Tyler A Churchward-Venne, Ph.D. principal investigator
McGill University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cricket-derived Protein and Beef-derived Protein in people with Aminoacidemia and Appetitive Behavior, run by McGill University at 1 site in Canada.
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 5 inclusion and 7 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 22 Jan 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 Canada. 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?
Plasma leucine concentration (time frame: 0-5 hours in the post-prandial period). The study lists 2 primary outcomes in all. 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 22 Jan 2021.