Status:
COMPLETED
Effects of the GOLO Weight Management Program With and Without Release Supplement on Weight and Metabolic Parameters in Subjects With Obesity
Lead Sponsor:
Golo
Conditions:
Obesity
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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 su...
Eligibility Criteria
Inclusion
- 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 such as brisk walking
- Willing to comply with study procedures described herein
Exclusion
- 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 of Mental 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 and GLP-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 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).
- 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 the principle investigator) heart, kidney or liver disease, cancer, or chronic neurological disease.
- Current participation in any other weight loss or weight management program
- Currently taking weight loss medications, or medications or supplements known to be associated with significant weight loss or weight gain
- 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
- \-
Key Trial Info
Start Date :
July 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 24 2018
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT03842501
Start Date
July 1 2018
End Date
December 24 2018
Last Update
February 15 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Buynak Clinical Research
Valparaiso, Indiana, United States, 46385