Irritable Bowel SyndromeGGGNCT06397924
Edible Insects: Good for the Gut and the Globe
A study testing Chitin Fiber in people with Irritable Bowel Syndrome, run by Colorado State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Chitin Fiber
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jul 2023to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 reporting current medication and dietary supplement use, along with the presence of other metabolic diseases, will be assessed on a case-by-case basis and may result in study exclusion
- individuals who feel that they will not be able to adhere to study requirements
Trial locations and contacts
1 site in 1 country.
United States1 site
Colorado State University
Fort Collins, Colorado, 80523-1571
About this study
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.
Read the detailed description
The study will take place in the Food and Nutrition Clinical Research Laboratory (FNCRL) located in the Gifford Building Room 216 on the Colorado State University campus. 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 for 30 days each, and collect four stool and four blood samples. (The two-and-a-half-month study will be broken into three parts: one 30-day fiber consumption period, one 14-day break, and a 30-day placebo consumption period.). The participant will be randomly assigned to Group A or Group B, but the treatment schedule for each is the same. 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. However, neither the participant nor the research personnel will know whether participants are consuming the placebo or the treatment bars during a specific period until after the study is complete and all data is analyzed.
One group will eat insect fiber-filled chocolate patty for 30 days and then take at least a 14-day break (called a wash-out), followed by 30 days of eating the placebo bars. The other group will eat the placebo patties for 30 days and then take a break of at least 14 days (wash-out), followed by 30 days of eating the cricket fiber patties. During the treatment periods, the participant will consume either 4g of cricket fiber or 4g of maltodextrin (a type of sugar) included in the chocolate patties.
At the baseline visits, as well as at the end of each treatment period, fasted blood and stool samples will be collected by trained research personnel at the FNCRL. This means that participants will have a total of four (4) clinic visits during the study. The participant will be required to drop off the first stool sample at a specified location after the first visit. Subsequent stool kits will be returned at the scheduled clinic visit. Additionally, at each visit, the participant will be weighed, and hip and waist circumference will be measured. The participant will also fill out several forms, including questionnaires about any IBS-related symptoms and about their quality of life. Finally, the participant will take home a form to track their daily bowel movements and a 3-day diet diary to record what the participant eats at the beginning and end of each treatment period.
All blood samples will be collected at Colorado State University by a trained professional. The research team will provide the participant with collection materials and instructions, and the participant will perform fecal sample collection.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Chitin Fiber, Placebo
- Keywords
- IBS, Cricket, Chitin, gut microbiome, gut health
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chitin FiberDietary supplement
Dietary fiber isolated from an edible insect (chitin)
PlaceboDietary supplement
Maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| Chitin Fiber | Active comparator | Chitin Fiber Receives: Dietary Supplement: Chitin Fiber |
| Placebo | Placebo comparator | Maltodextrin Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start6 Jul 2023
- Primary completion31 May 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Wisconsin, Madison
- Responsible party
- Principal investigator, Tiffany Weir, Colorado State University
- Investigators
- Tiffany Weir, MSc,PhD, Principal investigator, Colorado State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06397924
- Sponsor's protocol ID
- 2973
- Acronym
- GGG
- Status last verified
- Jul 2025
- First submitted
- 30 Apr 2024
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 30018370FAO, IFAD, UNICEF, WFP & WHO. The State of Food Security and Nutrition in the World 2018. Building Climate Resilience for Food Security and Nutrition. (2018).
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.
PubMed 22633998Prendergast 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.
PubMed 22556071Vita 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.
PubMed 40891151
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Edible Insects: Good for the Gut and the Globe
- ClinicalTrials.gov ID
- NCT06397924
- Acronym / sponsor ID
- GGG / 2973
- Conditions
- Irritable Bowel Syndrome
- Keywords
- IBS, Cricket, Chitin, gut microbiome, gut health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Collaborators
- University of Wisconsin, Madison
- Study start
- 6 Jul 2023 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 3 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will take place in the Food and Nutrition Clinical Research Laboratory (FNCRL) located in the Gifford Building Room 216 on the Colorado State University campus. 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 for 30 days each, and collect four stool and four blood samples. (The two-and-a-half-month study will be broken into three parts: one 30-day fiber consumption period, one 14-day break, and a 30-day placebo consumption period.). The participant will be randomly assigned to Group A or Group B, but the treatment schedule for each is the same. 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. However, neither the participant nor the research personnel will know whether participants are consuming the placebo or the treatment bars during a specific period until after the study is complete and all data is analyzed.
One group will eat insect fiber-filled chocolate patty for 30 days and then take at least a 14-day break (called a wash-out), followed by 30 days of eating the placebo bars. The other group will eat the placebo patties for 30 days and then take a break of at least 14 days (wash-out), followed by 30 days of eating the cricket fiber patties. During the treatment periods, the participant will consume either 4g of cricket fiber or 4g of maltodextrin (a type of sugar) included in the chocolate patties.
At the baseline visits, as well as at the end of each treatment period, fasted blood and stool samples will be collected by trained research personnel at the FNCRL. This means that participants will have a total of four (4) clinic visits during the study. The participant will be required to drop off the first stool sample at a specified location after the first visit. Subsequent stool kits will be returned at the scheduled clinic visit. Additionally, at each visit, the participant will be weighed, and hip and waist circumference will be measured. The participant will also fill out several forms, including questionnaires about any IBS-related symptoms and about their quality of life. Finally, the participant will take home a form to track their daily bowel movements and a 3-day diet diary to record what the participant eats at the beginning and end of each treatment period.
All blood samples will be collected at Colorado State University by a trained professional. The research team will provide the participant with collection materials and instructions, and the participant will perform fecal sample collection.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Chitin Fiber | Active comparator | Dietary Supplement: Chitin FiberChitin Fiber |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboMaltodextrin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (6 listed)
- 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 reporting current medication and dietary supplement use, along with the presence of other metabolic diseases, will be assessed on a case-by-case basis and may result in study exclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chitin FiberDietary fiber isolated from an edible insect (chitin) | Dietary supplement | Chitin Fiber |
| PlaceboMaltodextrin | Dietary supplement | Placebo |
Primary outcome
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.
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Background: PubMed 30018370Stull 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.
- BackgroundFAO, 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: PubMed 22633998Korpe 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.
- Background: PubMed 22556071Prendergast 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.
- Derived from this study: PubMed 40891151Vita 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tiffany Weir, MSc,PhD principal investigator
Colorado State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chitin Fiber in people with Irritable Bowel Syndrome, run by Colorado State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06397924, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.