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NCT02512107 · ClinicalTrials.gov registry record · NA
Impact of JuicePlus+ on the Health Status of an Overweight Stressed Population
A NA study, sponsored by University of Memphis.
- Completed
- Registry status
- NA
- Development phase
- 57
- Enrollment target
NCT02512107 is a NA study that has completed, run by University of Memphis. The registered enrollment target is 57 participants.
The verdict
NCT02512107, a NA study, has completed, sponsored by University of Memphis.
- COMPLETED
- Registry status
- NA
- Development phase
- 57 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if a dried fruit and vegetable supplement (Juice Plus+) can alter the gut microbiome and improve gut permeability and inflammatory levels in an obese, stressed population. The microbiome and its component genes are long known as critical determinants of the nutritional value of the food we eat. Recently, it has become clear that the composition of this microbiome and its metabolites influences the host immune system, thereby altering host physiology. Both obesity and chronic stress have been shown to have an altered gut microbiome; both these conditions also lead to increased systemic inflammatory molecules that can lead to an increased risk for type 2 diabetes and other diseases caused by chronic inflammation. Juice Plus+ consumed by an overweight population combined with an eight week exercise regime showed decreased markers of protein/lipid oxidation (ox-LDL), total lipid oxidation (TOS) and lowered systemic concentrations of the inflammatory cytokine, TNF-α. As systemic cytokines are altered by the composition of the gut microbiome, this study proposes to determine if this decrease in inflammation by Juice Plus+ is due to a change in the species composition and metabolism of the microbiome. This question is particularly relevant for populations with high inflammatory loads resulting from excess weight in addition to increased psychological stress. The investigators propose to determine 1) how Juice Plus+ consumption alters the microbiome species composition and metabolism, 2) if there is an alteration in intestinal permeability with the consumption of Juice Plus+ and 3) do these alterations coincide with lower systemic markers of inflammation and oxidative stress among individuals who are psychologically stressed and overweight. The investigators will use a randomized, placebo-controlled design with a cohort of overweight, female, critical care health care professionals. Subjects will receive the supplements or placeb
Interventions
- OTHER Placebo
- DIETARY_SUPPLEMENT Juice Plus+
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2015-01 |
| Est. Completion | 2019-04-27 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02512107
The ClinicalTrials.gov registry entry for NCT02512107 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 57 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Memphis, which has 35 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02512107 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02512107 about?
NCT02512107 is a clinical study titled "Impact of JuicePlus+ on the Health Status of an Overweight Stressed Population". The purpose of this study is to determine if a dried fruit and vegetable supplement (Juice Plus+) can alter the gut microbiome and improve gut permeability and inflammatory levels in an obese, stressed population. The microbiome and its component genes are long known as critical determinants of the...
What is the current status of trial NCT02512107?
This trial is currently completed. It is a NA study. The enrollment target is 57 participants. The study started on 2015-01. Estimated completion is 2019-04-27.
What interventions are being tested in trial NCT02512107?
The interventions under investigation include: Placebo (OTHER), Juice Plus+ (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT02512107?
This trial is sponsored by University of Memphis, which has 35 total clinical trials registered on ClinicalTrials.gov.
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