Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06622616
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-30
Brief Title:
NUTRITIONAL INTERVENTION STUDY to EVALUATE the EFFECT of ACHETA DOMESTICUS POWDER CONSUMPTION on GLUCOSE HOMEOSTASIS and INTESTINAL DYSBIOSIS in HEALTHY and PREDIABETIC POPULATION
Sponsor:
None
Organization:
None
Study Overview
Official Title:
NUTRITIONAL INTERVENTION STUDY to EVALUATE the EFFECT of ACHETA DOMESTICUS POWDER CONSUMPTION on GLUCOSE HOMEOSTASIS and INTESTINAL DYSBIOSIS in HEALTHY and PREDIABETIC POPULATION
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DIBAN
Brief Summary:
A nutritional intervention study is proposed to evaluate the association between the consumption of A domesticus insect protein powder and the effect on insulin resistance and the microbiome in order to generate personalized nutrition strategies through its analysis with artificial intelligence
This study is expected to involve 120 healthy volunteers between 18 and 65 years old with or without insulin resistance who will be recruited by IMDEA-Food This is a 12-week nutritional intervention study so you must come to Institute IMDEA-Food for a first screening visit V0 and if you meet the study inclusion criteria and are still interested in volunteering for the study you will be informed about the study sign the informed consent form and be scheduled for 2 more visits V1 or initial zero-time and V2 or final at IMDEA-Food39s facilities
This study is expected to involve 120 healthy volunteers between 18 and 65 years old with or without insulin resistance who will be recruited by IMDEA-Food This is a 12-week nutritional intervention study so you must come to Institute IMDEA-Food for a first screening visit V0 and if you meet the study inclusion criteria and are still interested in volunteering for the study you will be informed about the study sign the informed consent form and be scheduled for 2 more visits V1 or initial zero-time and V2 or final at IMDEA-Food39s facilities
Detailed Description:
In visit 1 basal visit the participant will provide a stool sample for microbiota analysis a fasting blood sample for biochemical genetic epigenetic and metabolomic analysis and then go to the nutrition consultation where medical history data and lifestyle habits will be collected a nutritional assessment will be made and the completed questionnaires will be corrected In addition they will be provided with continuous glucose monitoring sensors and an activity wristband to record lifestyle patterns The glucose sensors will be used for the first 14 and last 14 days of the intervention In addition all participants will be provided with the required amount of product until the next visit as well as how to consume store and ideas for consumption In addition a balanced normoprotein and varied diet and physical activity guidelines will be explained
In the second visit final the participant will again submit a stool sample for microbiota analysis a fasting blood sample will be taken for biochemical epigenetic and metabolomic analysis and then they will go to the nutrition clinic where a nutritional assessment will be made and the completed questionnaires will be corrected In addition the glucose sensor and the activity bracelet will be removed
During the intervention phase of the study participants will be able to come to the center for the collection of more product as well as for the review and troubleshooting of any problems with the sensors that may arise In turn halfway through the study 6 weeks a telephone survey will be conducted to participants to avoid travel in order to assess the degree of adherence and possible adverse effects
In the second visit final the participant will again submit a stool sample for microbiota analysis a fasting blood sample will be taken for biochemical epigenetic and metabolomic analysis and then they will go to the nutrition clinic where a nutritional assessment will be made and the completed questionnaires will be corrected In addition the glucose sensor and the activity bracelet will be removed
During the intervention phase of the study participants will be able to come to the center for the collection of more product as well as for the review and troubleshooting of any problems with the sensors that may arise In turn halfway through the study 6 weeks a telephone survey will be conducted to participants to avoid travel in order to assess the degree of adherence and possible adverse effects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None