Microbial Composition Clinical Trial
Official title:
An Open Label Study to Investigate a Polyphenol/Prebiotic Blend on Microbial Composition in Otherwise Healthy Obese Males and Females
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.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT03731702 -
Optimization of Collection Methods for Studies of the Human Microbiota
|