Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:35 PM
Ignite Modification Date:
2025-12-24 @ 5:35 PM
NCT ID:
NCT00780468
Eligibility Criteria:
Inclusion Criteria:
* Male or female 25-65 years of age inclusive
* Body Mass Index (BMI) 27.0 -35.0 inclusive.
* Not currently taking a prescription medication for weight loss (e.g. orlistat (Xenical), sibutramine (Meridia), phentermine).
* Not currently taking any over-the-counter weight loss medications or supplement(s).
* Not currently enrolled in commercial weight loss program (e.g. Jenny Craig, Weight Watchers) or self-help group (e.g. TOPS, Overeaters Anonymous).
* Willing and able to commit to regular physical activity (e.g. walking) five days per week as required by study protocol.
* Willing to keep and turn in a daily log/compliance book at the times required by study protocol.
* Willingness and ability to make all scheduled appointments at MUSC as required by study protocol.
* Willingness to make weekly meetings at MUSC.
Exclusion Criteria:
* History of thyroid disease, but not taking medication, or medication dosage changed one or more times over last 6 months. History of thyroid disease and on a stable dose of prescription medication for 6 months or longer is acceptable.
* Diagnosed with Type I or Type II diabetes or glucose intolerance, or use of anti-diabetic medications
* History of a surgical procedure for weight loss at any time (e.g. gastroplasty, gastric by-pass, gastrectomy or partial gastrectomy, adjustable banding, gastric sleeve).
* History of major surgery within three months of enrollment.
* History of heart problems (e.g. angina, bypass surgery, MI, etc.) within three months prior to enrollment.
* Presence of implanted cardiac defibrillator or pacemaker.
* Uncontrolled hypertension/high blood pressure.
* Orthopedic limitations that would interfere with ability to engage in regular physical activity.
* Gastrointestinal disorders including chronic malabsorptive conditions, peptic ulcer disease, Crohn's disease, chronic diarrhea or active gallbladder disease.
* History or presence of cancer. Persons with successfully resected basal cell carcinoma of the skin may be enrolled if treatment completed more than 6 months prior to enrollment.
* History of clinically diagnosed eating disorders including anorexia nervosa or bulimia nervosa.
* Women who are pregnant, lactating , trying to become pregnant or unwilling to use an effective means of birth control.
* Participation in another clinical trial within 30 days prior to enrollment.
* Weight loss of more than 5 pounds for any reason over the 30 days prior to enrollment.
* Taking any psychotropic medicine known to influence weight or weight loss
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
65 Years
Study:
NCT00780468
Study Brief:
Protocol Section:
NCT00780468