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:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 12:03 AM
NCT ID:
NCT02953158
Eligibility Criteria:
Inclusion Criteria:
Male or female between the ages of 20-60 years of age.
* Body Mass Index (BMI) 27.0 -35.0 kg/m2.
* Not currently taking a prescription medication for weight loss (e.g. orlistat (Xenical®), sibutramine (Meridia®) or phentermine etc.) If subject is willing to discontinue prescription medication(s) immediately and willing to refrain from taking medication(s) for duration of study, he/she may be enrolled after a four-week washout period.
* Not currently taking any over-the-counter weight loss supplement(s) or appetite suppressants (including OTC stimulants). If subject is willing to discontinue supplement(s) immediately and willing to refrain from taking supplement(s) for duration of study, he/she may be enrolled after a two-week washout period.
* Not currently enrolled in any commercial weight loss program (e.g. Jenny Craig, Weight Watchers), internet based weight-management program, self-help group (e.g. TOPS, Overeaters Anonymous) or participating in any food preparation/delivery program (eg Nutrisystems). If subject is willing to discontinue program immediately and willing to refrain from program for duration of study, he/she may be included after a two-week washout period.
* Willing to keep and turn in a daily log/compliance book as required by study protocol.
* Willingness and ability to make all scheduled appointments.
* Willing to follow dietary recommendations required by study protocol.
* Willingness to complete Dual X-Ray Absorptiometry (DXA) procedure.
* Willingness to periodically have small blood samples drawn as indicated in the protocol.
Exclusion Criteria:
More than a 5 pound weight gain or weight loss within the 3 months prior to enrollment in the study.
* 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. 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.
* History of a surgical procedure for weight loss at any time (e.g. gastroplasty, gastric by-pass, gastrectomy or partial gastrectomy).
* Gastrointestinal disorders including chronic malabsorptive conditions, peptic ulcer disease, Crohn's disease, chronic diarrhea or active gallbladder disease.
* History of inflammatory bowel disease.
* Following a diet that requires the elimination of FODMAPS•
* Following a specific diet that restricts specific food groups (eg. Paleo) or with extreme macronutrient ratios (carbohydrates, fats and proteins). • History of fatty liver.
* 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, bulimia nervosa or binge eating disorder.
* Women who are pregnant, lactating or trying to become pregnant.
* Currently taking any prescription medication for less than 3 months.
* Currently taking any prescriptions drugs that may impact weight regulation
* Currently consuming \>14 alcoholic drinks (1 drink = 12 fl oz beer, 4 fl oz wine or 1.5 fl oz liquor) per week and/or unwilling to limit intake to less than 3 drinks per week during study participation.
* Known allergy to avocados.
* History of alcohol dependency.
* Participation in another clinical trial within 30 days prior to enrollment.
* Currently smoking cigarettes.
* Any clinically significant food allergy.
* Currently consuming an average of \>1 avocado per week.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
60 Years
Study:
NCT02953158
Study Brief:
Protocol Section:
NCT02953158