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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03842501
• Other study ID #: GOLO1703
• Status: Completed
• Phase: Phase 3
• Start date: July 1, 2018
• Est. completion date: December 24, 2018

Study information

• Verified date: February 2019
• Source: Golo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: December 24, 2018
• Est. primary completion date: December 24, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Dietary Supplement:
• Release Supplement
Calorie reduced diet plus Release supplement
• Placebo
Calorie reduced diet plus Placebo

Locations

Country	Name	City	State
United States	Buynak Clinical Research	Valparaiso	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Golo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in weight from baseline		13 weeks
Secondary	Change in waist circumference from baseline		13 weeks
Secondary	Change in fasting glucose from baseline		13 weeks
Secondary	Change in Hemoglobin A1C from baseline		13 weeks