NCT06397924

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 3, 2024

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

July 24, 2025

Status Verified

July 1, 2025

Enrollment Period

11 months

First QC Date

April 30, 2024

Last Update Submit

July 23, 2025

Conditions

Keywords

IBSCricketChitingut microbiomegut health

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 COMPARATOR

Chitin Fiber

Dietary Supplement: Chitin Fiber

Placebo

PLACEBO COMPARATOR

Maltodextrin

Dietary Supplement: Placebo

Interventions

Chitin FiberDIETARY_SUPPLEMENT

Dietary fiber isolated from an edible insect (chitin)

Chitin Fiber
PlaceboDIETARY_SUPPLEMENT

Maltodextrin

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

Colorado State University

Fort Collins, Colorado, 80523-1571, United States

Location

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: 30018370BACKGROUND
  • FAO, IFAD, UNICEF, WFP & WHO. The State of Food Security and Nutrition in the World 2018. Building Climate Resilience for Food Security and Nutrition. (2018).

    BACKGROUND
  • Korpe 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: 22633998BACKGROUND
  • Prendergast 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: 22556071BACKGROUND
  • Vita 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.

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Tiffany Weir, MSc,PhD

    Colorado State University

    PRINCIPAL INVESTIGATOR

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
Model Details: One group will be given the small chocolate patties containing the insect chitin for 30 days, and the other group will be given the patties containing the placebo. The study was double-blinded.
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

Locations