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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01238887
• Other study ID #: 001
• Secondary ID: K23AT004251
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: August 6, 2010
• Last updated: March 27, 2014
• Start date: July 2011
• Est. completion date: April 2012

Study information

• Verified date: March 2014
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Oxidative Stress
• Weight Loss

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Florida General Clinical Research Center (GCRC)	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 every six weeks over a 30 week period	No
Secondary	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 every six weeks over a 30 week period	No
Secondary	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).	Every six weeks over a 30 week period	No
Secondary	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).	Every Six weeks for 30 weeks	No