Nutrition, HealthyInsectGEPNCT06771804
Cricket Flour Metabolism in Humans
A study testing Cricket Protein in people with Nutrition, Healthy, run by University of Surrey at 1 site in United Kingdom.
Trial summary
With increasing demands on the environment people are looking in different ways to decrease their carbon footprint. Protein is an important part of human diets a it provides building blocks for growth and helps to ensure people stay health. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrition, Healthy
- What is being tested?
- Cricket Protein
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2022to 8 Jan 2025
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Apparently healthy adult males and females between 20 and 55 years of age
- BMI between 18.5 and 35 kg/m2
- Weight stable for 3 months (± 2 kg)
- Volunteers must be able and willing to give informed written consent
- Volunteers must be able to eat egg (because egg is required for preparation of the stable isotope dosage see section experimental design).
Who cannot join
- Previous or current medical conditions, including heart disease, diabetes, gastrointestinal diseases (for example Crohn's disease, Coeliac disease, Inflammatory Bowel Disease), liver disease, endocrine diseases - assessed via a health questionnaire (appendix)
- Those taking (or have been taking within the past 6 months) regular medication, excluding contraceptive medication, or food supplements (e.g., vitamins, minerals, fish oil, fibre supplements, antioxidant tablets) - assessed via a health questionnaire (appendix) Those smoking, using nicotine products (e.g., e-cigarettes, patches) or not abstained from these activities for more than 6 months
- Pregnant or lactating
- Volunteers with a habitual caffeine intake > 300 mg/day (more than 5 cups standard coffee)
- Drug or alcohol abuse in the last 2 years
- The principal investigator considers it unsafe / unsuitable for the volunteer to be in the study
Show all 10Show fewer
- Those who are currently taking part in a clinical trial or another research study or have taken part within the last 3 months
- Those who do not refrain from alcohol, caffeine containing drinks (e.g., coffee, coca cola, tea, Red Bull) and strenuous exercise 10 hours before the laboratory session
- Those with food allergies, dietary intolerance (especially for egg), or Coeliac disease
- Those following weight reducing diets
Trial locations and contacts
1 site in 1 country.
About this study
With increasing demands on the environment people are looking in different ways to decrease their carbon footprint. Protein is an important part of human diets a it provides building blocks for growth and helps to ensure people stay health. Animal protein is one of the primary sources of of protein from our diets but it is also known that farming cattle for example places a lot of pressure on the environment. As a result of this new protein sources are being looked at that can take the place of animal protein. Insects have been consumed on many civilisations for a long time and they are slowly making their way into the western diets.
At this time the investigators however do not know very much about how well insect protein compares to animal protein as a nutritious food source. This research project is therefore one of the first to compare some of the nutritional properties between animal and insect proteins.
In brief, this study involves eating a sweet breakfast muffin made of either whey (animal) protein powder or cricket flour (very finely ground whole adult crickets) and then breathing into test tubes at various time points for a few hours as well as collecting some small amounts of blood using a finger stick to measure blood glucose and fats.
Read the detailed description
Insects have been used as protein source for many years in East-Asian and African populations, and more recently the interest in this potential protein source has been growing in Western countries due to the issues outlined above and increased awareness of animal welfare issues in the food chain. However, up until now there is no clear evidence that insect-derived protein has the same nutritional properties as its animal counterpart. Even though nutritional composition of insects can be similar or sometimes even better to support a healthy diet certain properties of the insects (such as the chitin in their exoskeleton) could have detrimental effects on their bioavailability. Gastric emptying (GE) describes the process of food being digested and absorbed by the controlled delivery from the stomach into the duodenum (1.). In the field of nutrition, GE is important, since a slower rate of GE can lead to a lower postprandial rise in macronutrients, and consequently a lower postprandial burden on their clearance. To date it is known that certain food properties such as volume, calories, and viscosity, as well as physiological factors such as age and gender can influence the gastric emptying rate (1.). However, the interaction between human physiology and different food in the stomach is widely unknown.
A slower GE rate is particularly important regarding postprandial plasma triacylglycerol concentrations, with impaired clearance being related to inflammation and cardiovascular disease. The attenuation of the postprandial increase in blood glucose has long been a goal for improved metabolic health. As reviewed, small differences in GE can have a major impact on postprandial glycaemia in health and type 2 diabetes (2.). Furthermore, a slowed gastric emptying rate as a result of certain types of food is associated with a delayed reoccurrence of feeling of hunger and can influence satiation.
The 13C octanoic acid breath test is a relatively cheap, non-invasive, and simple test to measure GE. The test is performed via the ingestion of a controlled meal containing the commercially available non-harmful stable isotope 13C in a short chain fatty acid (C8) and the following detection of the 13Clabelled CO2 in the breath (3.).
The data generated by the breath test is commonly analysed with a one compartment model based on Ghoos et al (1993) (4.) to generate parameters such as half time and lag time. More advanced semi mechanistic models are used in pharmacokinetics and could be applied to the breath test.
- Conditions
- Nutrition, Healthy
- Being tested
- Cricket Protein
- Keywords
- Nutrition, Alternative Protein, Gastric emptying
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cricket ProteinDietary supplement
Participants are provided with muffins containing either whey or cricket protein.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Whey Protein intervention Receives: Dietary Supplement: Cricket Protein |
| Insect | Experimental | Cricket Protein intervention Receives: Dietary Supplement: Cricket Protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Digestion
Gastric emptying
Measured: 4 hours post prandial
Secondary outcomes (3)
Digestion
T lag
Measured: 4 hours post prandial
Blood metabolites
Glucose
Measured: 4 hours post prandial
Blood metabolites
Cholesterol
Measured: 4 hours post prandial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start1 Oct 2022
- Primary completion1 Aug 2023
- Study completion8 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition, HealthyStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Surrey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06771804
- Sponsor's protocol ID
- FHMS 21-22 231 EGA
- Acronym
- InsectGEP
- Status last verified
- Jan 2025
- First submitted
- 7 Jan 2025
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD is planned
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cricket Flour Metabolism in Humans
- ClinicalTrials.gov ID
- NCT06771804
- Acronym / sponsor ID
- InsectGEP / FHMS 21-22 231 EGA
- Conditions
- Nutrition, Healthy
- Keywords
- Nutrition, Alternative Protein, Gastric emptying
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of SurreyUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 8 Jan 2025 (actual)
- First posted
- 13 Jan 2025 (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.
With increasing demands on the environment people are looking in different ways to decrease their carbon footprint. Protein is an important part of human diets a it provides building blocks for growth and helps to ensure people stay health. Animal protein is one of the primary sources of of protein from our diets but it is also known that farming cattle for example places a lot of pressure on the environment. As a result of this new protein sources are being looked at that can take the place of animal protein. Insects have been consumed on many civilisations for a long time and they are slowly making their way into the western diets.
At this time the investigators however do not know very much about how well insect protein compares to animal protein as a nutritious food source. This research project is therefore one of the first to compare some of the nutritional properties between animal and insect proteins.
In brief, this study involves eating a sweet breakfast muffin made of either whey (animal) protein powder or cricket flour (very finely ground whole adult crickets) and then breathing into test tubes at various time points for a few hours as well as collecting some small amounts of blood using a finger stick to measure blood glucose and fats.
Detailed description
Insects have been used as protein source for many years in East-Asian and African populations, and more recently the interest in this potential protein source has been growing in Western countries due to the issues outlined above and increased awareness of animal welfare issues in the food chain. However, up until now there is no clear evidence that insect-derived protein has the same nutritional properties as its animal counterpart. Even though nutritional composition of insects can be similar or sometimes even better to support a healthy diet certain properties of the insects (such as the chitin in their exoskeleton) could have detrimental effects on their bioavailability. Gastric emptying (GE) describes the process of food being digested and absorbed by the controlled delivery from the stomach into the duodenum (1.). In the field of nutrition, GE is important, since a slower rate of GE can lead to a lower postprandial rise in macronutrients, and consequently a lower postprandial burden on their clearance. To date it is known that certain food properties such as volume, calories, and viscosity, as well as physiological factors such as age and gender can influence the gastric emptying rate (1.). However, the interaction between human physiology and different food in the stomach is widely unknown.
A slower GE rate is particularly important regarding postprandial plasma triacylglycerol concentrations, with impaired clearance being related to inflammation and cardiovascular disease. The attenuation of the postprandial increase in blood glucose has long been a goal for improved metabolic health. As reviewed, small differences in GE can have a major impact on postprandial glycaemia in health and type 2 diabetes (2.). Furthermore, a slowed gastric emptying rate as a result of certain types of food is associated with a delayed reoccurrence of feeling of hunger and can influence satiation.
The 13C octanoic acid breath test is a relatively cheap, non-invasive, and simple test to measure GE. The test is performed via the ingestion of a controlled meal containing the commercially available non-harmful stable isotope 13C in a short chain fatty acid (C8) and the following detection of the 13Clabelled CO2 in the breath (3.).
The data generated by the breath test is commonly analysed with a one compartment model based on Ghoos et al (1993) (4.) to generate parameters such as half time and lag time. More advanced semi mechanistic models are used in pharmacokinetics and could be applied to the breath test.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Dietary Supplement: Cricket ProteinWhey Protein intervention |
| Insect | Experimental | Dietary Supplement: Cricket ProteinCricket Protein intervention |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Apparently healthy adult males and females between 20 and 55 years of age
Key exclusion criteria (10 listed)
- Previous or current medical conditions, including heart disease, diabetes, gastrointestinal diseases (for example Crohn's disease, Coeliac disease, Inflammatory Bowel Disease), liver disease, endocrine diseases - assessed via a health questionnaire (appendix)
- Those taking (or have been taking within the past 6 months) regular medication, excluding contraceptive medication, or food supplements (e.g., vitamins, minerals, fish oil, fibre supplements, antioxidant tablets) - assessed via a health questionnaire (appendix) Those smoking, using nicotine products (e.g., e-cigarettes, patches) or not abstained from these activities for more than 6 months
- Pregnant or lactating
- Volunteers with a habitual caffeine intake > 300 mg/day (more than 5 cups standard coffee)
- Drug or alcohol abuse in the last 2 years
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 ProteinParticipants are provided with muffins containing either whey or cricket protein. | Dietary supplement | Control, Insect |
Primary outcome
Digestion
Time frame: 4 hours post prandial
Gastric emptying
3 secondary outcomes
Digestion
Time frame: 4 hours post prandial
Blood metabolites
Time frame: 4 hours post prandial
Blood metabolites
Time frame: 4 hours post prandial
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 16 Jan 2025.
- Individual participant dataSharing planned: No. No IPD is planned
Related trials for Nutrition, Healthy
Active, not recruitingPhase 1
A Study of Multiple Doses of Orally Administered RO7795081 in Otherwise Healthy Chinese Adult Participants With Obesity or Overweight
Healthy Volunteers, Overweight or Obesity
RecruitingObservational study
Bariatric Surgery and Gut Microbiota Changes Over Time
Obese Patients, Obese Patients With Bariatric Surgery
Recruiting
Nutrition Outcomes Using a Randomized Intervention Via Smartphone on Dietary Habits
Healthy Adult Participants, Mindful Eating Intervention
Active, not recruitingPhase 1
A Study to Learn How the Study Medicine Called PF-08653945 is Taken up Into the Blood in Adults With Overweight or Obesity
Overweight, Obesity
RecruitingPhase 2
Effects of Sucralose on Drug Absorption and Metabolism (The SweetMeds Study)
Healthy Volunteers, Overweight
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Protein in people with Nutrition, Healthy, run by University of Surrey at 1 site in United Kingdom.
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 10 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 16 Jan 2025. 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 Kingdom. 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. Some participants in this study may receive a placebo. 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?
Digestion (time frame: 4 hours post prandial). 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 16 Jan 2025.