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NCT03383341 · ClinicalTrials.gov registry record · NA
What's Hopping? Cricket Protein and Human Gut Microbiota
A NA study of Healthy, sponsored by Colorado State University.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT03383341: Completed NA study of Healthy, sponsored by Colorado State University.
NCT03383341 is a NA study of Healthy that has completed, run by Colorado State University. The registered enrollment target is 20 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03383341, a NA study of Healthy, has completed, sponsored by Colorado State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study 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 composition of several insects is characterized, all potential health impacts have not been evaluated. Crickets contain chitin and other fibers that may influence gut health. In this study, we evaluated the effects of consuming 25 grams/day whole cricket powder on gut microbiota composition, while assessing safety and tolerability. Twenty healthy adults participated in this six-week, double-blind, crossover dietary intervention. Participants were randomized into two treatment arms and consumed either cricket-containing or control breakfast foods for 14 days, followed by a 14-day washout period and assignment to the opposite arm. Blood and stool samples were collected at baseline and after each treatment period to assess liver function and microbiota changes. Results demonstrate that cricket consumption is tolerable and non-toxic at the treatment dose. Cricket powder supported growth of the probiotic bacteria, Bifidobacterium animalis, which increased more than 5.7-fold. Cricket consumption was also associated with reduced plasma TNF-a. These data suggest that eating crickets may improve gut health and reduce systemic inflammation; however, more research is needed to understand these effects and underlying mechanisms.
Primary Outcome
Characterization of microbes in fecal samples using 16s sequencing methodologies.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Cricket Protein Powder
- OTHER Placebo control
Study Locations (1)
Colorado
- Colorado State University - Fort Collins
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2017-02-01 |
| Est. Completion | 2017-05-10 |
| Phase | NA |
What the finished NCT03383341 record still lists
NCT03383341 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Cricket Protein Powder is the first listed.
NCT03383341 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT03383341 about?
NCT03383341 is a clinical study titled "What's Hopping? Cricket Protein and Human Gut Microbiota". 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 composition of several insects is characterized, all potential health impacts have not been evaluate...
What is the current status of trial NCT03383341?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2017-02-01. Estimated completion is 2017-05-10.
What conditions does trial NCT03383341 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT03383341?
The interventions under investigation include: Cricket Protein Powder (DIETARY_SUPPLEMENT), Placebo control (OTHER).
Who is sponsoring clinical trial NCT03383341?
This trial is sponsored by Colorado State University, which has 94 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03383341 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03383341's enrollment target sits among peer trials
20 861st of 1090 higher than 194 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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