Clinical trial NCT03842501: Effects of the GOLO Weight Management Program With and Without Release Supplement on Weight and Metabolic Parameters in Subjects With Obesity
Official title: A Randomized, Double-blind, Placebo-controlled Study Evaluating the Effects of the GOLO Weight Management Program With and Without Release Supplement on Weight and Metabolic Parameters in Subjects With Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obesity
Lead sponsor: Golo
Sponsor class: INDUSTRY
First posted: 2019-02-15
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

    -

Primary outcomes:
measure: Change in weight from baseline
timeFrame: 13 weeks
Secondary outcomes:
measure: Change in waist circumference from baseline
timeFrame: 13 weeks
measure: Change in fasting glucose from baseline
timeFrame: 13 weeks
measure: Change in Hemoglobin A1C from baseline
timeFrame: 13 weeks
Other outcomes:
Locations:
city: Valparaiso
country: United States
facility: Buynak Clinical Research
state: Indiana
Study officials:
References: