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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03842501
Recruitment Status : Completed
First Posted : February 15, 2019
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Golo

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.

Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: Release Supplement Dietary Supplement: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : July 1, 2018
Actual Primary Completion Date : December 24, 2018
Actual Study Completion Date : December 24, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo Dietary Supplement: Placebo
Calorie reduced diet plus Placebo

Experimental: Release supplement Dietary Supplement: Release Supplement
Calorie reduced diet plus Release supplement




Primary Outcome Measures :
  1. Change in weight from baseline [ Time Frame: 13 weeks ]

Secondary Outcome Measures :
  1. Change in waist circumference from baseline [ Time Frame: 13 weeks ]
  2. Change in fasting glucose from baseline [ Time Frame: 13 weeks ]
  3. Change in Hemoglobin A1C from baseline [ Time Frame: 13 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03842501


Locations
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United States, Indiana
Buynak Clinical Research
Valparaiso, Indiana, United States, 46385
Sponsors and Collaborators
Golo

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Responsible Party: Golo
ClinicalTrials.gov Identifier: NCT03842501     History of Changes
Other Study ID Numbers: GOLO1703
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms