An interventional study of Blackberries and Control in Metabolic Syndrome, sponsored by Janet Novotny. Completed at 1 site in United States. Open to participants aged 25 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-07-22.
Sponsored by Janet Novotny · Not applicable and Interventional
Intestinal bacteria can metabolize unabsorbed polyphenols (plant compounds) to produce smaller molecules which may impact health. In addition, evidence suggests that this process may be affected by body fatness. This study aims to investigate absorption of blackberry polyphenols, their impact on intestinal bacteria, polyphenol metabolites formed by intestinal bacteria, and how these processes differ for obese and lean individuals. It is hypothesized that polyphenol absorption and metabolism will differ between obese and lean individuals and that differences in intestinal microbiota may play a role.
1,964 studies on the registry are indexed under Metabolic Syndrome; 330 are open to participants now.
This study's enrollment of 46 is below the median of 60 across 1,460 interventional studies indexed under Metabolic Syndrome.
Browse Metabolic Syndrome studies →Janet Novotny is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Participants will receive a controlled diet with the control food (jello) first and then cross over to the controlled diet with blackberries.
Other: Blackberries · Other: Control
Participants will receive a controlled diet with blackberries first and then cross over to the controlled diet with the control food (jello).
Other: Blackberries · Other: Control
Participants will receive blackberries as part of a controlled diet.
Participants will receive a control food (jello) as part of a controlled diet.
Change in fecal microbiota
Feces will be analyzed for bacterial typing at 0 and 4 weeks of each diet period.
Time frame: 0 weeks, 4 weeks
Change in blackberry nutrients & metabolites
Time frame: 0, 30, 60, 90, 120, 150, 180, 240, 300, 360, and 420 minutes
Change in gene expression
Gene expression in whole blood will be evaluated at the beginning and end of each diet period, through global gene expression using the Affymetrix platform. Changes in specific genes observed with global gene expression technology will be confirmed through RT-PCR.
Time frame: 0 weeks, 4 weeks
Change in metabolomics
Blood, urine, and feces will be analyzed by a technique called metabolomics, which is a broad sampling of metabolites.
Time frame: 0 weeks, 4 weeks
Change in biomarkers of cancer
Biomarkers of cancer risk such as oxidative stress and inflammatory markers will be analyzed at the beginning and end of each diet period.
Time frame: 0 weeks, 4 weeks
Change in lipopolysaccharide
Lipopolysaccharide will be measured in the blood as a measure of gut leakiness.
Time frame: 0 weeks, 4 weeks
This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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Janet Novotny