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NCT01238887 · ClinicalTrials.gov registry record · Phase 1
Investigations of Botanicals on Food Intake, Satiety, Weight Loss, and Oxidative Stress
A Phase 1 study, sponsored by University of Florida.
- Terminated
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT01238887 is a Phase 1 study that was terminated before completion, run by University of Florida. The registered enrollment target is 17 participants.
The verdict
NCT01238887, a Phase 1 study, was terminated before completion, sponsored by University of Florida.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
Study Summary
Despite widespread efforts to improve the treatment of obesity, only limited progress has been made. Calorie restriction (CR) has consistently been shown to produce weight loss, as well as delay the onset of age-related diseases, in numerous species. Most overweight individuals, however, are unable to sustain CR induced weight losses, possibly due to internal feedback systems that signal the body to increase food intake or decrease energy expenditure in response to weight loss. Novel treatment approaches are thus urgently needed that can assist overweight individuals in adhering to a CR regimen over the long-term. Botanicals represent an important and underexplored source of potential new therapies that may facilitate CR. In particular, one promising botanical that may reduce food intake and body weight by affecting neuroendocrine pathways related to satiety is Garcinia Cambogia (Garcinia Cambogia Desr.)-derived (-)-hydroxycitric acid. This compound has been found to facilitate weight loss in a number of studies. To date, few studies have directly tested the effect that this botanical on food intake in humans, its mechanism of action, or its effect on oxidative stress levels; thus rigorous scientific studies on this compounds need to be conducted. A double-blind, placebo-controlled crossover study will be conducted to explore the role that two different doses of this botanical compound have on food intake, satiety, weight loss, and oxidative stress levels. It is hypothesized that compared to placebo, both doses of Garcinia Cambogia (hydroxycitric acid) will reduce food intake, increase satiety, decrease weight, and reduce oxidative stress levels.
Interventions
- DIETARY_SUPPLEMENT Microcrystalline Cellulose placebo pill
- DIETARY_SUPPLEMENT Garcinia cambogia-derived hydroxycitric acid (2800 mg/day)
- DIETARY_SUPPLEMENT Garcinia Cambogia derived Hydroxycitric Acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2011-07 |
| Est. Completion | 2012-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01238887
The ClinicalTrials.gov registry entry for NCT01238887 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Microcrystalline Cellulose placebo pill is the first listed.
NCT01238887 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01238887 about?
NCT01238887 is a clinical study titled "Investigations of Botanicals on Food Intake, Satiety, Weight Loss, and Oxidative Stress". Despite widespread efforts to improve the treatment of obesity, only limited progress has been made. Calorie restriction (CR) has consistently been shown to produce weight loss, as well as delay the onset of age-related diseases, in numerous species. Most overweight individuals, however, are unable ...
What is the current status of trial NCT01238887?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2011-07. Estimated completion is 2012-04.
What interventions are being tested in trial NCT01238887?
The interventions under investigation include: Microcrystalline Cellulose placebo pill (DIETARY_SUPPLEMENT), Garcinia cambogia-derived hydroxycitric acid (2800 mg/day) (DIETARY_SUPPLEMENT), Garcinia Cambogia derived Hydroxycitric Acid (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01238887?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
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