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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: Release Supplement
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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 such as brisk walking Willing to comply with study procedures described herein 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 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 -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* Calorie reduced diet plus Placebo<br>|
| Experimental: Release supplement<br> | Dietary Supplement: Release Supplement<br>* Calorie reduced diet plus Release supplement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in weight from baseline |  | 13 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |