Effects of the GOLO Weight Management Program With and Without Release Supplement on Weight and Metabolic Parameters in Subjects With Obesity

Inclusion Criteria:

1. Age ≥ 18 years and ≤ 80 years

2. Body mass index (BMI) ≥ 30 and ≤ 60 kg/m2

3. Have the ability to engage in at least 15 minutes of moderate physical activity such
as brisk walking

4. Willing to comply with study procedures described herein

Exclusion Criteria:

1. Current diagnosis of type 1 diabetes

2. Subjects with a history of hypoglycemia

3. A history of an eating disorder as defined by the Diagnostic and Statistical Manual of
Mental Disorders, Fifth Edition (DSM-5)

4. Known allergy to any of the components in the Release supplement

5. A history of prior surgery for weight loss

6. Currently taking injectable medications to control diabetes, including insulin and
GLP-1 agonists

7. Currently pregnant or breastfeeding or have had a baby within the last six weeks

8. Planning to become pregnant in the next three months. Women of child bearing potential
must be willing and able to use adequate and reliable contraception throughout the
study (e.g. abstinence or barrier with additional spermicidal foam or jelly, or the
use of intrauterine device or hormonal contraception).

9. Uncontrolled hypertension at screening defined as Systolic blood pressure greater than
180 mmHG or Diastolic blood pressure greater than 110 mmHG

10. Current clinical diagnosis or signs and symptoms of unstable (in the opinion of the
principle investigator) heart, kidney or liver disease, cancer, or chronic
neurological disease.

11. Current participation in any other weight loss or weight management program

12. Currently taking weight loss medications, or medications or supplements known to be
associated with significant weight loss or weight gain

13. Has any condition that, in the opinion of the investigator, would make participation
in this study not in the best interest of the subject or that could prevent, limit or
confound the protocol-specified assessments. Examples include: history of diabetic
ketoacidosis; 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 associated
with marked disorders of digestion or absorption