Ignite Creation Date:
2025-12-24 @ 1:29 PM
Ignite Modification Date:
2026-02-13 @ 4:55 PM
Study NCT ID:
NCT02743195
Status:
COMPLETED
Last Update Posted:
2016-08-03
First Post:
2016-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Polyphenol/Prebiotic Blend Effects on GI Health and Microbial Composition
Sponsor:
Pharmanex
Organization:
Study Overview
Official Title:
An Open Label Study to Investigate a Polyphenol/Prebiotic Blend on Microbial Composition in Otherwise Healthy Obese Males and Females
Status:
COMPLETED
Status Verified Date:
2016-08
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 gastrointestinal (GI) ecosystem is a complex network of bacterial cells, host cells and tissues that change with age. Fewer numbers and less diversity of beneficial bacteria and greater number and diversity of non-beneficial bacteria occurs with age and conditions associated with accelerated aging (i.e. obesity, high fat diet)(1,2). This imbalance of the microbiota contributes to increased inflammation of the gastrointestinal lining and changes to the integrity of the intestinal cell wall.
Prebiotics, such as non-digestible carbohydrates, can induce the growth or activity microorganisms that contribute to the well-being of the host. Recent studies have shown that prebiotic treatment can have beneficial effects on glucose levels, lipid metabolism, and inflammatory markers in an obese population(3). The polyphenol blend is rich in anthocyanins, which is a unique subgroup of flavonoids that have been demonstrated to impact the microbiome and have anti-inflammatory properties(4,5,6,7). This open-label study will assess the benefits of a prebiotic and polyphenol blend in healthy obese adults.
Prebiotics, such as non-digestible carbohydrates, can induce the growth or activity microorganisms that contribute to the well-being of the host. Recent studies have shown that prebiotic treatment can have beneficial effects on glucose levels, lipid metabolism, and inflammatory markers in an obese population(3). The polyphenol blend is rich in anthocyanins, which is a unique subgroup of flavonoids that have been demonstrated to impact the microbiome and have anti-inflammatory properties(4,5,6,7). This open-label study will assess the benefits of a prebiotic and polyphenol blend in healthy obese adults.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 16PMHN | OTHER | KGK Synergize Inc. | View |