- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06397924
Edible Insects: Good for the Gut and the Globe (GGG)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Colorado
-
Fort Collins, Colorado, United States, 80523-1571
- Colorado State University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo
Maltodextrin
|
Maltodextrin
|
|
Active Comparator: Chitin Fiber
|
Dietary fiber isolated from an edible insect (chitin)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Tiffany Weir, MSc,PhD, Colorado State University
Publications and helpful links
General Publications
- 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.
- 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.
- 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).
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2973
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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