- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06906159
Cricket Protein Bioavailability in Younger, Middle-Aged and Older Adults (CriProB)
Cricket Protein Bioavailability in Younger, Middle-Aged and Alder Adults
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Participants are asked to fast overnight and come in the following day for one of two visits where they are given a standardised breakfast muffin containing either cricket protein or whey protein (250-300 kcal; approx. 12% fat, 45% carbohydrates including 10% sugars, 35% protein, 0.4% salt and 6% fibre) after which they breathe into a test tube in 15-30 minute intervals for 4 hours. In addition to this, we collect a blood sample (10ml) every 15 minutes for the first hour and then every 30 minutes for the next 3 hours (110ml of blood in total per visit) so we can determine changes in blood amino acids, glucose and fat concentrations after eating the muffin. In total we only collect a small amount of blood. This method of blood collection is the same method used for a traditional blood test but to avoid repeated needle insertions we use a cannula which remains in the participant's arm for the duration of the visit so that only a single needle insertion is necessary.
The muffin contains a small amount of a natural fat called octanoic acid. The octanoic acid is enriched with carbon-13. This is a natural variant of carbon and is safe to use, even in babies and pregnant women. At the end of each test visit we ask participants to fill out a short questionnaire to ask about the taste of the muffins. Participants are required to repeat this whole process for a second visit in which they consume the other muffin.
The muffins are identical between the two test visits with the exception that one muffin is made with a milk-based protein (whey) whereas the other test muffin is made with an insect protein (cricket). The test muffins are similar in size, shape, and taste. Participants are randomised to a muffin condition in a crossover design. Participants are blinded to the muffin condition and only one member of the research team knows which muffin participants receive on which test visit but they are not present during the test visits. The researchers conducting the test visits do not know which muffin is being consumed by participants.
Participants are required to attend for 2 test visits each lasting approximately 5 hours. This takes place in the Clinical Investigation Unit (CIU) at the University of Surrey. On the day before each of the test visits participants are asked to arrive fasted for 12 hours overnight, refrain from strenuous exercise, alcohol, caffeine and food containing corn, broccoli, sugarcane, and tropical fruits (because of the type of natural carbon-13 they contain) the day before their visits.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Surrey
-
Guildford, Surrey, United Kingdom, GU2 7XH
- University of Surrey
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy adult males and females in general good health, aged between 18 - 35 years, 40 - 55 years or over 65 years
- BMI between 18.5 and 35 kg/m2
- Stable weight for at least 3 months
- Volunteers must be able and willing to give informed written consent
- Volunteers must be able to eat egg
- Volunteers must be willing to provide blood samples
Exclusion Criteria:
- Current or previous gastrointestinal conditions (e.g. Crohn's disease, Coeliac disease, Irritable Bowel Syndrome) - assessed via a health questionnaire
- Those with diabetes or other metabolic conditions - assessed via a health questionnaire
- Those taking food supplements which may impact digestion (e.g., digestive enzymes, probiotics, fibre supplements)
- Those smoking, using nicotine products (e.g., e-cigarettes, patches) or not abstained from these activities for more than 6 months - assessed via a health questionnaire
- Pregnant or lactating
- Volunteers with a high daily caffeine intake > 300 mg/day (more than 5 cups of standard coffee per day)
- Drug or alcohol abuse in the last 2 years
- Those who are currently taking part in a clinical trial or another research study or have taken part within the last 3 months
- Those with food allergies, dietary intolerance or Coeliac disease - assessed via a health questionnaire
- Those following weight loss diets
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cricket muffin
Muffin made with cricket-derived protein powder
|
Muffins made with cricket-derived protein from house crickets (Acheta domesticus )
|
|
Active Comparator: Whey muffin
Muffin made with whey protein powder
|
Muffins made with whey protein
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gastric emptying
Time Frame: 4 hour post-prandial period
|
Exhaled breath is used to assess the rate of gastric emptying of the protein muffins
|
4 hour post-prandial period
|
|
Plasma amino acids
Time Frame: 4 hour post-prandial period
|
Blood samples are used to assess the plasma amino acid response to consuming the protein muffins
|
4 hour post-prandial period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Metabolic markers
Time Frame: 4 hour post-prandial period
|
Blood samples are also used to assess post-prandial glucose, triglycerides and cholesterol
|
4 hour post-prandial period
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: James Rutherford, MSc, University of Surrey
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CriProB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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