Back to resultsEffects of the GOLO Weight Management Program With and Without Release Supplement on Weight and Metabolic Parameters in Subjects With Obesity
Primary Purpose
Obesity
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Release Supplement
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Obesity
Eligibility Criteria
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
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Sites / Locations
- Buynak Clinical Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Release supplement
Arm Description
Outcomes
Primary Outcome Measures
Change in weight from baseline
Secondary Outcome Measures
Change in waist circumference from baseline
Change in fasting glucose from baseline
Change in Hemoglobin A1C from baseline
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03842501
Brief Title
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
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
December 24, 2018 (Actual)
Study Completion Date
December 24, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Golo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Release supplement
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Release Supplement
Intervention Description
Calorie reduced diet plus Release supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Calorie reduced diet plus Placebo
Primary Outcome Measure Information:
Title
Change in weight from baseline
Time Frame
13 weeks
Secondary Outcome Measure Information:
Title
Change in waist circumference from baseline
Time Frame
13 weeks
Title
Change in fasting glucose from baseline
Time Frame
13 weeks
Title
Change in Hemoglobin A1C from baseline
Time Frame
13 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
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Facility Information:
Facility Name
Buynak Clinical Research
City
Valparaiso
State/Province
Indiana
ZIP/Postal Code
46385
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effects of the GOLO Weight Management Program With and Without Release Supplement on Weight and Metabolic Parameters in Subjects With Obesity
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