NCT03478202

GOLO Open-Label Pilot 1

An Open-Label Pilot Study Evaluating the Effect of the GOLO for Life Weight Management Program on Weight and Metabolic Syndrome Indicators in Patients With Type II Diabetes Mellitus

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Golo · Industry
• Sex: All
• Age: 18 Years – 69 Years
• Healthy volunteers: Not accepted

Summary

The objective of this open-label pilot study is to evaluate the effect of the commercially available GOLO for Life (GFL) weight management program on body weight in a type 2 diabetic patient population after approximately 3 months.

Detailed description

Golo For Life (GFL) is a weight management program that helps people who are overweight or obese limit and portion their consumption of conventional foods and make healthier choices in their diets. GFL includes a point-based system from the four macronutrient food groups that is based on the individual's activity level and body mass. Additionally, GFL includes common-sense instructions, motivation and tips supporting compliance and requires a minimum of 15 minutes of exercise per day. GFL also includes a dietary supplement containing zinc and chromium, essential nutrients that support regulation of blood sugar. In case studies from clinician and wellness program use, GFL has shown the ability to reduce body weight in both healthy and diabetic people who are overweight or obese. Secondary endpoints including measures of blood sugar have been observed to decrease as a result of the GFL program. While GFL has been developed and used in private clinical practice in both healthy overweight and type 2 diabetic people, more systematic research is needed to determine to what extent it is able to support healthy weight loss. This open-label pilot study is intended to observe the effects of the program in a representative group of subjects with stable type 2 diabetes at one outpatient medical practice. The objective of this open-label pilot study is to evaluate the effect of the commercially available GOLO for Life (GFL) weight management program on body weight in a type 2 diabetic patient population after approximately 3 months.

Conditions

• Diabetes Mellitus, Type II

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	GOLO RELEASE	GOLO RELEASE plus Diet

Timeline

• Start date: 2017-08-01
• Primary completion: 2017-12-23
• Completion: 2017-12-23
• First posted: 2018-03-27
• Last updated: 2018-03-27

Locations

1 site across 1 country: United States