Edible Insects: Good for the Gut and the Globe
GGG
1 other identifier
interventional
18
1 country
1
Brief Summary
Edible insects have been eaten by people throughout human history and are consumed today across the globe. Insects are also currently being incorporated into a number of food products in the United States, Canada, and Europe due to their unique nutritional and sustainability attributes. Insects have been touted as an environmental alternative to conventional meat products, but they are unique in containing dietary fiber. The investigators have recently demonstrated in a population of healthy individuals that two weeks of consuming 25 g/day cricket powder may be associated with prebiotic effects by stimulating the growth of Bifidobacterium in the gut. In addition, participants had reduced inflammatory markers in the blood after the cricket intervention. Crickets and other edible insects contain a unique form of fiber called chitin. They would like to explore whether chitin may be responsible for these previously observed effects and particularly if chitin consumption can mitigate symptoms and inflammation associated with the gastrointestinal disorder Irritable Bowel Syndrome (IBS). This project aims to examine the impact of consuming 4 grams of cricket-derived chitin daily for 30 days on the gut microbiota, intestinal and systemic markers of inflammation, and symptom severity and quality of life in individuals with IBS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 6, 2023
CompletedFirst Submitted
Initial submission to the registry
April 30, 2024
CompletedFirst Posted
Study publicly available on registry
May 3, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2024
CompletedJuly 24, 2025
July 1, 2025
11 months
April 30, 2024
July 23, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Examine the impact that consuming 4 grams of cricket-derived chitin daily for 30 days has on the gut microbiota, intestinal and systemic markers of inflammation, and symptom severity and quality of life in individuals with IBS.
The time commitment for the study is approximately two and a half months, during which participants will spend ~1 hour (15-20 min/visit) at clinic appointments, eat small chocolate bars containing either the cricket chitin or a maltodextrin placebo daily
Study Arms (2)
Chitin Fiber
ACTIVE COMPARATORChitin Fiber
Placebo
PLACEBO COMPARATORMaltodextrin
Interventions
Eligibility Criteria
You may qualify if:
- Participants must be 18 years of age or older with a medical diagnosis of Irritable Bowel Syndrome (IBS) and/or recurrent abdominal pain greater than 1 time per week persistent for at least 3 months while also meeting 2 of the 3 criteria for IBS diagnosis according to the Rome IV assessment. Both adult males and females of any race or ethnicity will be included in this study. (Rome IV Diagnostic Criteria for IBS link: www.mdcalcl.com/rome-iv-diagnostic-criteria-irritable-bowel-syndrome-ibs)
You may not qualify if:
- pregnant and lactating women,
- individuals taking antibiotics or who have recently taken antibiotics (within 60 days of the study start date),
- individuals with any self-reported shellfish, milk, or soy allergies
- individuals with a current diagnosis of inflammatory bowel disease, gastrointestinal cancers, other cancers, liver or kidney disease,
- individuals who feel that they will not be able to adhere to study requirements
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Colorado State Universitylead
- University of Wisconsin, Madisoncollaborator
Study Sites (1)
Colorado State University
Fort Collins, Colorado, 80523-1571, United States
Related Publications (5)
Stull VJ, Finer E, Bergmans RS, Febvre HP, Longhurst C, Manter DK, Patz JA, Weir TL. Impact of Edible Cricket Consumption on Gut Microbiota in Healthy Adults, a Double-blind, Randomized Crossover Trial. Sci Rep. 2018 Jul 17;8(1):10762. doi: 10.1038/s41598-018-29032-2.
PMID: 30018370BACKGROUNDFAO, IFAD, UNICEF, WFP & WHO. The State of Food Security and Nutrition in the World 2018. Building Climate Resilience for Food Security and Nutrition. (2018).
BACKGROUNDKorpe PS, Petri WA Jr. Environmental enteropathy: critical implications of a poorly understood condition. Trends Mol Med. 2012 Jun;18(6):328-36. doi: 10.1016/j.molmed.2012.04.007. Epub 2012 May 25.
PMID: 22633998BACKGROUNDPrendergast A, Kelly P. Enteropathies in the developing world: neglected effects on global health. Am J Trop Med Hyg. 2012 May;86(5):756-63. doi: 10.4269/ajtmh.2012.11-0743.
PMID: 22556071BACKGROUNDVita AA, Teo S, Murphy C, Khandaker AM, Hart RA, Mathews P, Wilson JW, Chaparro J, Aquilino T, Dinsmore I, Wei Y, Stull VJ, Weir TL. Safety, tolerability, and preliminary effects of cricket chitin for adults with IBS: a double-blind randomized crossover pilot trial. Food Funct. 2025 Sep 15;16(18):7434-7454. doi: 10.1039/d5fo01540e.
PMID: 40891151DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tiffany Weir, MSc,PhD
Colorado State University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 30, 2024
First Posted
May 3, 2024
Study Start
July 6, 2023
Primary Completion
May 31, 2024
Study Completion
August 31, 2024
Last Updated
July 24, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF