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

University of Florida

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Obesity; Oxidative Stress

Treatments: Dietary Supplement: Garcinia Cambogia derived Hydroxycitric Acid; Dietary Supplement: Microcrystalline Cellulose placebo pill; Dietary Supplement: Garcinia cambogia-derived hydroxycitric acid (2800 mg/day)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01238887

K23AT004251 (U.S. NIH Grant/Contract)

001

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 50 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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17 participants in 3 patient groups, including a placebo group

microcrystalline cellulose

Placebo Comparator group

Treatment:

Dietary Supplement: Microcrystalline Cellulose placebo pill

Hydroxycitric acid

Active Comparator group

Description:

2800 mg divided in three doses per day

Treatment:

Dietary Supplement: Garcinia cambogia-derived hydroxycitric acid (2800 mg/day)

Dietary Supplement: Garcinia Cambogia derived Hydroxycitric Acid

Hydroxycitric Acid

Active Comparator group

Description:

5400 mg divided into three doses per day

Treatment:

Dietary Supplement: Garcinia cambogia-derived hydroxycitric acid (2800 mg/day)

Dietary Supplement: Garcinia Cambogia derived Hydroxycitric Acid