Trials / Completed
CompletedNCT02743195
Polyphenol/Prebiotic Blend Effects on GI Health and Microbial Composition
An Open Label Study to Investigate a Polyphenol/Prebiotic Blend on Microbial Composition in Otherwise Healthy Obese Males and Females
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 51 (actual)
- Sponsor
- Pharmanex · Industry
- Sex
- All
- Age
- 20 Years – 60 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Polyphenol/prebiotic blend |
Timeline
- Start date
- 2016-03-01
- Primary completion
- 2016-06-01
- Completion
- 2016-06-01
- First posted
- 2016-04-19
- Last updated
- 2016-08-03
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT02743195. Inclusion in this directory is not an endorsement.