Phase
Condition
Obesity
Diabetes Prevention
Treatment
N/AClinical Study ID
Ages 18-80 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥ 18 years and ≤ 80 years
Body mass index (BMI) ≥ 30 and ≤ 60 kg/m2
Have the ability to engage in at least 15 minutes of moderate physical activity suchas brisk walking
Willing to comply with study procedures described herein
Exclusion
Exclusion Criteria:
Current diagnosis of type 1 diabetes
Subjects with a history of hypoglycemia
A history of an eating disorder as defined by the Diagnostic and Statistical Manual ofMental Disorders, Fifth Edition (DSM-5)
Known allergy to any of the components in the Release supplement
A history of prior surgery for weight loss
Currently taking injectable medications to control diabetes, including insulin andGLP-1 agonists
Currently pregnant or breastfeeding or have had a baby within the last six weeks
Planning to become pregnant in the next three months. Women of child bearing potentialmust be willing and able to use adequate and reliable contraception throughout thestudy (e.g. abstinence or barrier with additional spermicidal foam or jelly, or theuse of intrauterine device or hormonal contraception).
Uncontrolled hypertension at screening defined as Systolic blood pressure greater than 180 mmHG or Diastolic blood pressure greater than 110 mmHG
Current clinical diagnosis or signs and symptoms of unstable (in the opinion of theprinciple investigator) heart, kidney or liver disease, cancer, or chronicneurological disease.
Current participation in any other weight loss or weight management program
Currently taking weight loss medications, or medications or supplements known to beassociated with significant weight loss or weight gain
Has any condition that, in the opinion of the investigator, would make participationin this study not in the best interest of the subject or that could prevent, limit orconfound the protocol-specified assessments. Examples include: history of diabeticketoacidosis; active chronic liver disease or cirrhosis; chronic autoimmune disease;inflammatory bowel disease, colonic ulceration, partial intestinal obstruction,subjects predisposed to intestinal obstruction; chronic intestinal diseases associatedwith marked disorders of digestion or absorption
Study Design
Connect with a study center
Buynak Clinical Research
Valparaiso, Indiana 46385
United StatesSite Not Available
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