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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: Clinical Trial Phase 1 study, sponsored by University of Florida.
NCT01238887 is a Phase 1 study that was terminated before completion, run by University of Florida. The registered enrollment target is 17 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Participant food intake will be measured at each meal of every test meal day, once at breakfast, lunch, and dinner. Test meal days occur at the baseline visit, after six weeks of the the first condition (week 6), after the following six week wash out period (week 12), after the following six weeks of the second condition (week 18), after the following six week wash out period (week 24), and after the six weeks of the third and final condition (week 30). Conditions include both the doses of the t
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 |
Why NCT01238887 stopped before completion
NCT01238887 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 3 interventions - of which Microcrystalline Cellulose placebo pill is the first listed.
NCT01238887 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01238887's enrollment target sits among peer trials
17 1785th of 2000 higher than 215 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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