Status:
COMPLETED
What's Hopping? Cricket Protein and Human Gut Microbiota
Lead Sponsor:
Colorado State University
Collaborating Sponsors:
University of Wisconsin, Madison
Conditions:
Healthy
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Edible insects are often considered a nutritious, protein-rich, environmentally sustainable alternative to traditional meat. They represent a new food for North American consumers. While the nutrient ...
Detailed Description
Although no research on the impact of edible insect protein powder on the human microbiome, there is plenty of evidence that edible insects offer a good source nutrition. Extensive research demonstrat...
Eligibility Criteria
Inclusion
- Apparently healthy males and non-pregnant or lactating healthy females of any race or ethnicity and between the ages of 18-65 with a BMI between 18.5-29.9.
Exclusion
- Individuals younger than 18 years of age or older than 65 years, and those outside of the BMI range of 18.5-29.9 will be excluded. Individuals will also be excluded if they have taken antibiotics or commercial probiotic/prebiotic supplements within two months of the start of the study treatment. Subjects who self-report food allergies will be excluded from the study because some proteins in insect foods are similar to those found in shellfish that could trigger an allergic reaction and tree nut or dairy products may be used in the breakfast foods.
- Additionally, current medications and dietary supplements will be assessed on a case by case basis and will result in exclusion if there is a possibility that the drugs or supplements used would influence the endpoints of the study. This would include statins, metformin, non-steroidal anti-inflammatory drugs (NSAID), Monoamine oxidase inhibitors (MAOI), and botanical supplements that target the gastrointestinal tract or gut microbiota. Individuals with current diagnosis of cancer, liver or kidney disease, gastrointestinal diseases, and metabolic disorders will also be excluded. Pregnant and breastfeeding women will be excluded from the study as well. Additionally, exclusion will be determined if the individual feels they are unable to adhere to the study requirements which include consuming 1 prepared breakfast per day (treatment or placebo) for a total of 28 days (treatment periods), making 3 clinic visits, and providing 3 blood and stool samples.
Key Trial Info
Start Date :
February 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 10 2017
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03383341
Start Date
February 1 2017
End Date
May 10 2017
Last Update
April 4 2019
Active Locations (1)
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1
Colorado State University
Fort Collins, Colorado, United States, 80523-1571