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

NCT ID: NCT01238887

Last Updated: 2014-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity Oxidative Stress

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Satiety Food Intake Weight Loss Oxidative Stress botanicals Garcinia Cambogia-derived hydroxycitric acid

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

microcrystalline cellulose

Group Type PLACEBO_COMPARATOR

Microcrystalline Cellulose placebo pill

Intervention Type DIETARY_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.

Hydroxycitric acid

2800 mg divided in three doses per day

Group Type ACTIVE_COMPARATOR

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

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type DIETARY_SUPPLEMENT

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.

Hydroxycitric Acid

5400 mg divided into three doses per day

Group Type ACTIVE_COMPARATOR

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

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Hydroxycitric Acid (HCA) Hydroxycitric Acid (HCA)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Stephen Anton, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Florida, Department of Aging and Geriatric Research

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Florida General Clinical Research Center (GCRC)

Gainesville, Florida, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 12151467 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22088584 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

K23AT004251

Identifier Type: NIH

Identifier Source: secondary_id

View Link

001

Identifier Type: -

Identifier Source: org_study_id