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

This study has suspended participant recruitment.
(Some capsules used in this study were been found to be cracked and leaking.)
Sponsor:
Collaborator:
National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01238887
First received: August 6, 2010
Last updated: May 7, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Obesity
Oxidative Stress
 Dietary Supplement: Microcrystalline Cellulose placebo pill
Dietary Supplement: Garcinia cambogia-derived hydroxycitric acid (2800 mg/day)
Dietary Supplement: Garcinia Cambogia derived Hydroxycitric Acid
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Investigations of Botanicals on Food Intake, Satiety, Weight Loss, and Oxidative Stress

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Food Intake (kcal/day) [ Time Frame: Measured every six weeks over a 30 week period ] [ Designated as safety issue: No ]
    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 treatment and the placebo dose as well.


Secondary Outcome Measures:
  • Satiety [ Time Frame: Measured every six weeks over a 30 week period ] [ Designated as safety issue: No ]
    Participants will provide satiety ratings throughout the test meal day. 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).

  • Body Weight [ Time Frame: Every six weeks over a 30 week period ] [ Designated as safety issue: No ]
    Fasting body weights will be taken at each of the test meal visits. 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).

  • Oxidative Stress [ Time Frame: Every Six weeks for 30 weeks ] [ Designated as safety issue: No ]
    Fasting blood draws will be taken at each of the test meal visits. 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).


Estimated Enrollment: 48
Study Start Date: July 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: microcrystalline cellulose 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.
Active Comparator: Hydroxycitric acid
2800 mg divided in three doses per day
 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.
Other Name: Hydroxycitric Acid (HCA)
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.
Other Name: Hydroxycitric Acid (HCA)
Active Comparator: Hydroxycitric Acid
5400 mg divided into three doses per day
 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.
Other Name: Hydroxycitric Acid (HCA)
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.
Other Name: Hydroxycitric Acid (HCA)

  Eligibility

Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. healthy individual with normal blood chemistries and platelet counts who has not been diagnosed with diabetes, cardiovascular illness, or other chronic diseases
  2. 50 to 70 years of age
  3. body mass index between 25 and 39.9 kg/m2
  4. for females, post-menopausal (i.e., no menstrual cycle for > one year).

Exclusion Criteria:

  1. Potential participants will be excluded if their scores on the dietary restraint, disinhibition, and perceived hunger scales of the Eating Inventory are high (>14)
  2. Participants who report smoking cigarettes will be excluded because of the effects of nicotine upon taste and appetite
  3. Participants who have a diagnosable eating disorder will also be excluded since intentional restriction of eating and binge eating/overeating could increase the variability of the data
  4. Participants will be excluded if they are taking anti-depressant medications, anti-psychotic medications, or any medications, botanicals, or other products that may potentially influence appetite, hunger, and/or satiety
  5. Participants will be excluded if they report alcohol or substance abuse within 6 months or consumption of >14 alcohol drinks/week
  6. Participants will also be excluded if they report any allergies to the foods used in the study

  7. Volunteers will also be ineligible if they have significant medical conditions (e.g., history or clinical manifestation of cardiovascular disease, diabetes, cholelithiasis, liver or renal disease, or cancer)

    • abnormal laboratory markers (e.g., renal or liver abnormalities, elevated potassium levels or hemoglobin and hematocrit below the lower limit of normal)
    • psychiatric or behavioral problems (e.g., eating disorders or a history of drug and alcohol abuse)
    • concomitant medications (e.g., steroids)
  8. Volunteers will be screened out if they are unwilling or unable to adhere to different supplement regimens over an eight month period.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01238887

Locations
United States, Florida
University of Florida General Clinical Research Center (GCRC)
Gainesville, Florida, United States, 32608
Sponsors and Collaborators
University of Florida
National Center for Complementary and Alternative Medicine (NCCAM)
Investigators
Principal Investigator: Stephen Anton, Ph.D. University of Florida, Department of Aging and Geriatric Research
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01238887     History of Changes
Other Study ID Numbers: 001, K23AT004251
Study First Received: August 6, 2010
Last Updated: May 7, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
Satiety
Food Intake
Weight Loss
 Oxidative Stress
botanicals
Garcinia Cambogia-derived hydroxycitric acid

Additional relevant MeSH terms:
Obesity
Weight Loss
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on May 23, 2013