Ignite Creation Date:
2024-05-06 @ 2:53 AM
Last Modification Date:
2024-10-26 @ 11:25 AM
Study NCT ID:
NCT02151825
Status:
COMPLETED
Last Update Posted:
2014-05-30
First Post:
2014-05-28
Brief Title:
Effect of a Synbiotic on the Gut Microbiota and Adiposity-related Markers in Healthy Overweight Subjects
Sponsor:
Texas State University San Marcos
Organization:
Texas State University San Marcos
Study Overview
Official Title:
Pilot Study on the Influence of a Synbiotic Formulation ProSynbiotic on Gut Microbiota Composition Adiposity and Selected Markers of Cardiometabolic Health in Overweight or Moderately Obese Individuals
Status:
COMPLETED
Status Verified Date:
2014-05
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:
None
Brief Summary:
The purpose of this study is to investigate the effects of a synbiotic ProSynbiotic on the gut microbiota composition body composition and adiposity-related genes and metabolic markers in healthy overweight adult subjects
Detailed Description:
This is a parallel double-blind randomized placebo controlled trial to determine the effects of a synbiotic formulation ProSynbiotic containing 4 billion CFU of a probiotic blend of Bifidobacterium lactis BB-12 Lactobacillus acidophilus LA-5 Lactobacillus casei 431 and Saccharomyces boulardii along with 1 g of the prebiotic inulin and 100 mg of galactooligosaccharide GOS on the gut microbiota composition body composition expression of genes mediating dietary energy harvest and adiposity and on adiposity-related metabolic markers in healthy free-living overweight or moderately obese subjects The duration of the study is 18 weeks including a 2-week run-in period before randomization of subjects into the synbiotic or placebo group a 12-week intervention period and a 4-week follow-up after the end of the intervention During the intervention period subjects will be instructed to take 3 capsules of either synbiotic or placebo per day and maintain their habitual diet and physical activity They will also be asked to document any unusual symptoms or side effects as well as keep a bowel diary Diet and physical activity will be monitored via 24-h dietary recalls and the global physical activity questionnaire respectively Changes in the gut microbiota composition will be determined by measuring bacterial population levels in stool sampled collected at baseline 6 weeks 12 weeks and the follow up time point Body composition will be measured using the BOD POD at baseline 6 weeks and 12 weeks Gene expression levels will be assessed at baseline and 12 weeks in colonocytes isolated from stool samples and PBMCs isolated from blood samples by qPCR Metabolic markers will be measured at baseline and 12-weeks in plasma or serum using the respective biochemical- or immuno-assays
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 110021 | OTHER | Texas State University | None |