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

NCT03842501 | Completed Phase 3

• 1 other identifier: GOLO1703
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Change in weight from baseline

  13 weeks

Secondary Outcomes (3)

• Change in waist circumference from baseline

  13 weeks

• Change in fasting glucose from baseline

  13 weeks

• Change in Hemoglobin A1C from baseline

  13 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Release supplement

EXPERIMENTAL

Dietary Supplement: Release Supplement

Interventions

Release Supplement DIETARY_SUPPLEMENT

Calorie reduced diet plus Release supplement

Release supplement

Placebo DIETARY_SUPPLEMENT

Calorie reduced diet plus Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Golo: lead

Study Sites (1)

Buynak Clinical Research

Valparaiso, Indiana, 46385, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2019
• First Posted: February 15, 2019
• Study Start: July 1, 2018
• Primary Completion: December 24, 2018
• Study Completion: December 24, 2018
• Last Updated: February 15, 2019

Record last verified: 2019-02

Locations

US (1)