Back to resultsInvestigations of Botanicals on Food Intake, Satiety, Weight Loss, and Oxidative Stress
Primary Purpose
Obesity, Oxidative Stress
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Microcrystalline Cellulose placebo pill
Garcinia cambogia-derived hydroxycitric acid (2800 mg/day)
Garcinia Cambogia derived Hydroxycitric Acid
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Satiety, Food Intake, Weight Loss, Oxidative Stress, botanicals, Garcinia Cambogia-derived hydroxycitric acid
Eligibility Criteria
Inclusion Criteria:
- healthy individual with normal blood chemistries and platelet counts who has not been diagnosed with diabetes, cardiovascular illness, or other chronic diseases
- 50 to 70 years of age
- body mass index between 25 and 39.9 kg/m2
- for females, post-menopausal (i.e., no menstrual cycle for > one year).
Exclusion Criteria:
- Potential participants will be excluded if their scores on the dietary restraint, disinhibition, and perceived hunger scales of the Eating Inventory are high (>14)
- Participants who report smoking cigarettes will be excluded because of the effects of nicotine upon taste and appetite
- 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
- 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
- Participants will be excluded if they report alcohol or substance abuse within 6 months or consumption of >14 alcohol drinks/week
- Participants will also be excluded if they report any allergies to the foods used in the study
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)
- Volunteers will be screened out if they are unwilling or unable to adhere to different supplement regimens over an eight month period.
Sites / Locations
- University of Florida General Clinical Research Center (GCRC)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
microcrystalline cellulose
Hydroxycitric acid
Hydroxycitric Acid
Arm Description
2800 mg divided in three doses per day
5400 mg divided into three doses per day
Outcomes
Primary Outcome Measures
Food Intake (kcal/day)
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
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
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
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).
Full Information
NCT ID
NCT01238887
First Posted
August 6, 2010
Last Updated
March 27, 2014
Sponsor
University of Florida
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT01238887
Brief Title
Investigations of Botanicals on Food Intake, Satiety, Weight Loss, and Oxidative Stress
Official Title
Investigations of Botanicals on Food Intake, Satiety, Weight Loss, and Oxidative Stress
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Terminated
Why Stopped
Some capsules used in this study were been found to be cracked and leaking.
Study Start Date
July 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Oxidative Stress
Keywords
Satiety, Food Intake, Weight Loss, Oxidative Stress, botanicals, Garcinia Cambogia-derived hydroxycitric acid
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
microcrystalline cellulose
Arm Type
Placebo Comparator
Arm Title
Hydroxycitric acid
Arm Type
Active Comparator
Arm Description
2800 mg divided in three doses per day
Arm Title
Hydroxycitric Acid
Arm Type
Active Comparator
Arm Description
5400 mg divided into three doses per day
Intervention Type
Dietary Supplement
Intervention Name(s)
Microcrystalline Cellulose placebo pill
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Garcinia cambogia-derived hydroxycitric acid (2800 mg/day)
Other Intervention Name(s)
Hydroxycitric Acid (HCA)
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Garcinia Cambogia derived Hydroxycitric Acid
Other Intervention Name(s)
Hydroxycitric Acid (HCA)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Food Intake (kcal/day)
Description
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.
Time Frame
Measured every six weeks over a 30 week period
Secondary Outcome Measure Information:
Title
Satiety
Description
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).
Time Frame
Measured every six weeks over a 30 week period
Title
Body Weight
Description
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).
Time Frame
Every six weeks over a 30 week period
Title
Oxidative Stress
Description
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).
Time Frame
Every Six weeks for 30 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy individual with normal blood chemistries and platelet counts who has not been diagnosed with diabetes, cardiovascular illness, or other chronic diseases
50 to 70 years of age
body mass index between 25 and 39.9 kg/m2
for females, post-menopausal (i.e., no menstrual cycle for > one year).
Exclusion Criteria:
Potential participants will be excluded if their scores on the dietary restraint, disinhibition, and perceived hunger scales of the Eating Inventory are high (>14)
Participants who report smoking cigarettes will be excluded because of the effects of nicotine upon taste and appetite
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
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
Participants will be excluded if they report alcohol or substance abuse within 6 months or consumption of >14 alcohol drinks/week
Participants will also be excluded if they report any allergies to the foods used in the study
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)
Volunteers will be screened out if they are unwilling or unable to adhere to different supplement regimens over an eight month period.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Anton, Ph.D.
Organizational Affiliation
University of Florida, Department of Aging and Geriatric Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida General Clinical Research Center (GCRC)
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
12151467
Citation
Kenchaiah S, Evans JC, Levy D, Wilson PW, Benjamin EJ, Larson MG, Kannel WB, Vasan RS. Obesity and the risk of heart failure. N Engl J Med. 2002 Aug 1;347(5):305-13. doi: 10.1056/NEJMoa020245.
Results Reference
background
PubMed Identifier
22088584
Citation
Anton SD, Shuster J, Leeuwenburgh C. Investigations of botanicals on food intake, satiety, weight loss and oxidative stress: study protocol of a double-blind, placebo-controlled, crossover study. Zhong Xi Yi Jie He Xue Bao. 2011 Nov;9(11):1190-8. doi: 10.3736/jcim20111106.
Results Reference
derived
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Investigations of Botanicals on Food Intake, Satiety, Weight Loss, and Oxidative Stress
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