Ignite Creation Date:
2024-05-06 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06213480
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-19
First Post:
2023-12-20
Brief Title:
Next-Generation Synbiotic in Individuals With Overweight or Obesity
Sponsor:
Texas Christian University
Organization:
Texas Christian University
Study Overview
Official Title:
Supplementation With a Next-Generation Synbiotic in Individuals With Overweight or Obesity A Triple-Blinded Randomized Controlled Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
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:
None
Brief Summary:
This study plans to evaluate the effect of consuming a symbiotic probiotic prebiotic for 3 months on body weight body composition glucose sensitivity and psychological parameters as well as on gut and blood microbial composition Synbiotic consumption is preceded by a 3-day antibiotic course to help ensure the opening of new niches houses for the upcoming beneficial bacteria
Detailed Description:
This is a triple-blinded randomized clinical trial in which participants will be allocated to one of two groups 1 3-day antibiotic followed by synbiotic consumption for 3 months or 2 3-day antibiotic followed by placebo consumption for 3 months
Blood and stool samples will be collected before the antibiotic and before and after the symbiotic intervention in both groups
Gut microbial composition will be analyzed through whole genome sequencing and blood microbial composition through 16S rRNA
Glucose sensitivity will be measured through fasting glucose fasting insulin and HbA1c
Body composition through DXA and BodPod will be measured before and after the symbiotic intervention
Psychological questionnaires such as the Beck Anxiety and the Beck Depression Inventories as well as the RED-9 questionnaire to respectively measure anxiety depression and food cravings will be applied before and after the symbiotic intervention
Blood and stool samples will be collected before the antibiotic and before and after the symbiotic intervention in both groups
Gut microbial composition will be analyzed through whole genome sequencing and blood microbial composition through 16S rRNA
Glucose sensitivity will be measured through fasting glucose fasting insulin and HbA1c
Body composition through DXA and BodPod will be measured before and after the symbiotic intervention
Psychological questionnaires such as the Beck Anxiety and the Beck Depression Inventories as well as the RED-9 questionnaire to respectively measure anxiety depression and food cravings will be applied before and after the symbiotic intervention
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