| Eligibility |
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.
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