Obesity
Conditions
Brief summary
This randomized, double-blind placebo-controlled study was intended to measure the effects of the GWMP with Release supplement versus GWMP with placebo supplement in a representative group of obese subjects with or without diabetes at one outpatient medical practice.
Interventions
DIETARY_SUPPLEMENTRelease Supplement
Calorie reduced diet plus Release supplement
DIETARY_SUPPLEMENTPlacebo
Calorie reduced diet plus Placebo
Sponsors
Golo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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 \-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in weight from baseline | 13 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change in waist circumference from baseline | 13 weeks |
| Change in fasting glucose from baseline | 13 weeks |
| Change in Hemoglobin A1C from baseline | 13 weeks |
Countries
United States
Outcome results
None listed