Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06397924
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-07
First Post:
2024-04-30
Brief Title:
Edible Insects Good for the Gut and the Globe
Sponsor:
Colorado State University
Organization:
Colorado State University
Study Overview
Official Title:
Edible Insects Good for the Gut and the Globe
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GGG
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 gday 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 minvisit 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None