Clinical trial NCT01238887: 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
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Obesity
Oxidative Stress
Keywords: Satiety
Food Intake
Weight Loss
Oxidative Stress
botanicals
Garcinia Cambogia-derived hydroxycitric acid
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2010-11-11
Enrollment: 17
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Food Intake (kcal/day)
timeFrame: Measured every six weeks over a 30 week period
Secondary outcomes:
measure: Satiety
timeFrame: Measured every six weeks over a 30 week period
measure: Body Weight
timeFrame: Every six weeks over a 30 week period
measure: Oxidative Stress
timeFrame: Every Six weeks for 30 weeks
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida General Clinical Research Center (GCRC)
state: Florida
Study officials:
affiliation: University of Florida, Department of Aging and Geriatric Research
name: Stephen Anton, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.