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

Last updated: February 14, 2019
Sponsor: Golo
Overall Status: Completed

Phase

3

Condition

Obesity

Diabetes Prevention

Treatment

N/A

Clinical Study ID

NCT03842501
GOLO1703
  • Ages 18-80
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 suchas brisk walking

  4. Willing to comply with study procedures described herein

Exclusion

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 ofMental 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 andGLP-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 potentialmust be willing and able to use adequate and reliable contraception throughout thestudy (e.g. abstinence or barrier with additional spermicidal foam or jelly, or theuse 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 theprinciple investigator) heart, kidney or liver disease, cancer, or chronicneurological 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 beassociated with significant weight loss or weight gain

  13. Has any condition that, in the opinion of the investigator, would make participationin this study not in the best interest of the subject or that could prevent, limit orconfound the protocol-specified assessments. Examples include: history of diabeticketoacidosis; 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 associatedwith marked disorders of digestion or absorption

Study Design

Total Participants: 68
Study Start date:
July 01, 2018
Estimated Completion Date:
December 24, 2018

Connect with a study center

  • Buynak Clinical Research

    Valparaiso, Indiana 46385
    United States

    Site Not Available

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