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 @ 4:16 AM
Ignite Modification Date:
2025-12-25 @ 4:16 AM
NCT ID:
NCT04706520
Eligibility Criteria:
Inclusion Criteria:
1. Males and females between 18 and 60 years of age (inclusive) of any ethnicity, free of medications except for oral contraceptives (see inclusion criterion 8).
2. Subjects are overweight at screening (Visit 1, Day -14), as defined by a BMI of between 25.0 to ˂30.0 kg/m2, inclusive.
3. Subjects have abdominal obesity at screening (Visit 1, Day -14), as defined by a waist circumference of \>102 cm for males or \>88 cm for females (ATP III, 2001).
4. Physical examination and vital signs are normal, or deemed abnormal but clinically insignificant by the Principle and/or Medical Investigator.
5. Clinical laboratory evaluations (including but not limited to clinical chemistry \[fasted at least 8 hours\], including creatine phosphokinase (CPK)\], amylase, lipid profile, thyroid stimulating hormone (TSH), free thyroxine (T4), cortisol) complete blood count (CBC), are within the reference ranges for the central laboratory, unless deemed not clinically significant by the Investigator.
6. Males who are sterile or agree to use an approved method of contraception, with an approved method of contraception considered a barrier method (diaphragm, cervical cap, or condom) plus a contraceptive jelly (spermicidal foam, gel, film, cream, or suppository). If the female sexual partner of the male is using an approved form of contraception (see inclusion criterion 8), the male is not required to be sterile or, if not sterile, to use an approved form of contraception.
7. Female subjects who are postmenopausal (absence of menses for 1 year or more), women who are surgically sterilized, or women of child-bearing potential (WOCBP) who are nonlactating and have been using an effective form of birth control for a minimum of 6 months prior to screening and agree to continue using the effective form of birth control during the study and for 30 days after the treatment period \[effective forms of birth control include oral pills with a concentration of at least 50 μg of the estrogenic component of a biphasic or triphasic pill; transdermal, injectable, or implantable contraceptive; intrauterine device; or double-barrier method (e.g., diaphragm and condom). Abstinence is not considered an acceptable form of birth control.\] WOCBP who are using low dose oral birth control must also use a barrier method of contraception for the duration of the study.
8. Subjects who, during the investigative period, are willing to:
1. Consume the prescribed amount of vinegar beverage;
2. Wear the accelerometer (Fitbit);
3. Complete food intake diary as required.
4. Collect stool sample
5. Willing to archive blood and stool samples
9. Subjects who are capable of giving informed consent and complying with all study procedures/ requirements.
Exclusion Criteria:
1. Subjects who, in the past 6 months, have dieted or have used any supplement/medication intended to affect body weight or suppress appetite
2. Subjects with a history of an eating disorder in the last 5 years.
3. Subjects who have had or are planning to have bypass surgery, stomach banding surgery, or any other surgical procedure(s), including those of a cosmetic nature, that attempt to aid/promote weight loss or alter body composition.
4. Subjects with Type I or Type 2 diabetes mellitus.
5. Subjects with endocrine disease (thyroid dysfunction defined by serum levels of T4, TSH or a past diagnosis of Cushing syndrome).
6. Subjects who have a history or presence of significant pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunological (e.g., HIV/AIDS), dermatologic, urological, neurological, psychiatric, or cardiovascular disease or disorder.
7. Subjects with any implanted electric device (such as a cardiac defibrillator) or other medical device that would allow for them to perform an MRI.
8. Women with polycystic ovarian syndrome.
9. Women who began taking oral contraceptives or hormone replacement therapy recently, within the last 6 months.
10. Women who plan to become pregnant during the study or were pregnant or nursing within the past year.
11. Subjects who have recently undergone barium tests/exams (within 7 days), or who have had a nuclear medicine scan or injection with an x-ray dye (within 3 days).
12. Subjects who have a history or presence of alcoholism or drug abuse within the previous 2 years and/or a positive urine drug screen at screening.
13. Subjects who have quit smoking in the last 6 months or who plan on quitting/altering smoking habits during their participation in this clinical trial.
14. Subjects who donated 1 pint or more of blood or blood products within 56 days prior to the study, and/or had a plasma donation within 7 days prior to the study or who plan to donate blood or blood products during their participation in this clinical trial.
15. Subjects with poor peripheral venous access that would preclude blood collection.
16. Subjects who are currently participating or plan to participate in any other investigational trial in which receipt of an investigational product will occur.
17. Subject who resides in the same household as another subject already participating in the study.
18. Subjects who have any condition that would make them, in the opinion of the Investigator, unsuitable for the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT04706520
Study Brief:
Protocol Section:
NCT04706520