ObesityPhase 1/2NCT01238887
Investigations of Botanicals on Food Intake, Satiety, Weight Loss, and Oxidative Stress
A Phase 1/2 study testing Garcinia cambogia-derived hydroxycitric acid (2800 mg/day) and Garcinia Cambogia derived Hydroxycitric Acid in people with Obesity and Oxidative Stress, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Oxidative Stress
- What is being tested?
- Garcinia cambogia-derived hydroxycitric acid (2800 mg/day) and Garcinia Cambogia derived Hydroxycitric Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Apr 2012
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida General Clinical Research Center (GCRC)
Gainesville, Florida, 32608
About this study
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
- Obesity, Oxidative Stress
- Being tested
- Microcrystalline Cellulose placebo pill, Garcinia cambogia-derived hydroxycitric acid (2800 mg/day), Garcinia Cambogia derived Hydroxycitric Acid
- Keywords
- Satiety, Food Intake, Weight Loss, Oxidative Stress, botanicals, Garcinia Cambogia-derived hydroxycitric acid
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microcrystalline Cellulose placebo pillDietary supplement
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.
Garcinia cambogia-derived hydroxycitric acid (2800 mg/day)Dietary supplement
Also called Hydroxycitric Acid (HCA)
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.
Garcinia Cambogia derived Hydroxycitric AcidDietary supplement
Also called Hydroxycitric Acid (HCA)
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.
| Study group | Role | What they receive |
|---|---|---|
| microcrystalline cellulose | Placebo comparator | Not described Receives: Dietary Supplement: Microcrystalline Cellulose placebo pill |
| Hydroxycitric acid | Active comparator | 2800 mg divided in three doses per day Receives: Dietary Supplement: Garcinia cambogia-derived hydroxycitric acid (2800 mg/day); Dietary Supplement: Garcinia Cambogia derived Hydroxycitric Acid |
| Hydroxycitric Acid | Active comparator | 5400 mg divided into three doses per day Receives: Dietary Supplement: Garcinia cambogia-derived hydroxycitric acid (2800 mg/day); Dietary Supplement: Garcinia Cambogia derived Hydroxycitric Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Measured every six weeks over a 30 week period
Secondary outcomes (3)
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).
Measured: Measured every six weeks over a 30 week period
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).
Measured: Every six weeks over a 30 week period
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).
Measured: Every Six weeks for 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2010 (estimated)
- Study startJul 2011
- Primary completionApr 2012
- Study completionApr 2012
Why it stopped: Some capsules used in this study were been found to be cracked and leaking.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Stephen Anton, Ph.D., Principal investigator, University of Florida, Department of Aging and Geriatric Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01238887
- Sponsor's protocol ID
- 001
- Other IDs
- K23AT004251
- Status last verified
- Mar 2014
- First submitted
- 6 Aug 2010
- Last updated
- 31 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 12151467Anton 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.
PubMed 22088584
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigations of Botanicals on Food Intake, Satiety, Weight Loss, and Oxidative Stress
- ClinicalTrials.gov ID
- NCT01238887
- Acronym / sponsor ID
- 001
- Conditions
- Obesity, Oxidative Stress
- Keywords
- Satiety, Food Intake, Weight Loss, Oxidative Stress, botanicals, Garcinia Cambogia-derived hydroxycitric acid
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Some capsules used in this study were been found to be cracked and leaking.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Jul 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 11 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| microcrystalline cellulose | Placebo comparator | Dietary Supplement: Microcrystalline Cellulose placebo pill |
| Hydroxycitric acid | Active comparator | Dietary Supplement: Garcinia cambogia-derived hydroxycitric acid (2800 mg/day), Dietary Supplement: Garcinia Cambogia derived Hydroxycitric Acid2800 mg divided in three doses per day |
| Hydroxycitric Acid | Active comparator | Dietary Supplement: Garcinia cambogia-derived hydroxycitric acid (2800 mg/day), Dietary Supplement: Garcinia Cambogia derived Hydroxycitric Acid5400 mg divided into three doses per day |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microcrystalline Cellulose placebo pillParticipants 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 | microcrystalline cellulose |
| Garcinia cambogia-derived hydroxycitric acid (2800 mg/day)Also: Hydroxycitric Acid (HCA)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 | Hydroxycitric Acid, Hydroxycitric acid |
| Garcinia Cambogia derived Hydroxycitric AcidAlso: Hydroxycitric Acid (HCA)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. | Dietary supplement | Hydroxycitric Acid, Hydroxycitric acid |
Primary outcome
Food Intake (kcal/day)
Time frame: Measured every six weeks over a 30 week period
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.
3 secondary outcomes
Satiety
Time frame: Measured every six weeks over a 30 week period
Body Weight
Time frame: Every six weeks over a 30 week period
Oxidative Stress
Time frame: Every Six weeks for 30 weeks
Results and safety
The study was stopped early (reason given: Some capsules used in this study were been found to be cracked and leaking.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2014.
- Background: PubMed 12151467Kenchaiah 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.
- Derived from this study: PubMed 22088584Anton 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Anton, Ph.D. principal investigator
University of Florida, Department of Aging and Geriatric Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Garcinia cambogia-derived hydroxycitric acid (2800 mg/day) and Garcinia Cambogia derived Hydroxycitric Acid in people with Obesity and Oxidative Stress, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Some capsules used in this study were been found to be cracked and leaking.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Food Intake (kcal/day) (time frame: Measured every six weeks over a 30 week period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01238887, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2014.