Status:
TERMINATED
Investigations of Botanicals on Food Intake, Satiety, Weight Loss, and Oxidative Stress
Lead Sponsor:
University of Florida
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Obesity
Oxidative Stress
Eligibility:
All Genders
50-70 years
Phase:
PHASE1
PHASE2
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 o...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT01238887
Start Date
July 1 2011
End Date
April 1 2012
Last Update
March 31 2014
Active Locations (1)
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1
University of Florida General Clinical Research Center (GCRC)
Gainesville, Florida, United States, 32608