Investigations of Botanicals on Food Intake, Satiety, Weight Loss, and Oxidative Stress

NCT01238887 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2014-03-31

No results posted yet for this 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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Microcrystalline Cellulose placebo pill

Participants will be given gelatin capsules containing the placebo (microcrystaline cellulose) and will be instructed to consume four capsules three times daily (30 minutes before breakfast, lunch, and dinner) with a glass of water. This will equal 3000 mg/day of the placebo contents. Participants will be instructed to follow this dosing regimen throughout the six week treatment period.

DIETARY_SUPPLEMENT

Garcinia cambogia-derived hydroxycitric acid (2800 mg/day)

The hydroxycitric acid treatment is derived from garcinia cambogia and is provided by the company, Glykon Technologies. In this condition, participants will receive HCA at a dosage of 2,800 mg/day in the form of gelatin capsules. Participants will be instructed to consume four capsules three times daily (30 minutes before breakfast, lunch, and dinner) with a glass of water. Participants will be instructed to follow this dosing regimen throughout the six week treatment period.

DIETARY_SUPPLEMENT

Garcinia Cambogia derived Hydroxycitric Acid

The hydroxycitric acid treatment is derived from garcinia cambogia and is provided by the company, Glykon Technologies. In this condition, participants will receive HCA at a dosage of 5,400 mg/day in the form of gelatin capsules. Participants will be instructed to consume four capsules three times daily (30 minutes before breakfast, lunch, and dinner) with a glass of water. Participants will be instructed to follow this dosing regimen throughout the six week treatment period.

Sponsors & Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

    collaborator NIH
  • University of Florida

    lead OTHER

Principal Investigators

  • Stephen Anton, Ph.D. · University of Florida, Department of Aging and Geriatric Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
50 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01238887 on ClinicalTrials.gov