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Dietary Supplement
GOLO for Life® Plan + Release for Weight Management in Obesity
Phase 2
Waitlist Available
Led By David Crowley, MD
Research Sponsored by Golo
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Males and females between the age of 18-65 years, inclusive, at screening
Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, day 90, day 180
Awards & highlights
Study Summary
This trial investigates how the GOLO for Life® Plan (G4LP) and Release supplementation affects weight, body fat, and cardiometabolic parameters in overweight/obese adults. Safety/tolerability is also monitored.
Who is the study for?
Adults aged 18-65 with a BMI of 25-39.9, not pregnant or planning pregnancy, and non-smokers can join this weight management trial. They must be willing to follow the GOLO for Life Plan, use approved birth control if applicable, and have had stable body weight recently.Check my eligibility
What is being tested?
The study tests the GOLO for Life Plan with Release supplement's effectiveness on weight loss and health markers like body fat percentage over six months. Participants' progress is tracked using DEXA scans and other measurements.See study design
What are the potential side effects?
Potential side effects are not specified but will be monitored through reports of adverse events during the trial to ensure safety and tolerability of the GOLO for Life Plan and Release supplement.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 65 years old.
Select...
I cannot have children because I've had surgery or have been menopausal for over a year.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, day 90, day 180
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, day 90, day 180
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The change in fat mass (kilograms) following the GOLO for Life® Plan (G4LP) and supplementation with Release.
The change in fat mass (percent) following the GOLO for Life® Plan (G4LP) and supplementation with Release.
The change in weight (kilograms) following the GOLO for Life® Plan (G4LP) and supplementation with Release.
+1 moreSecondary outcome measures
The change in android fat (percent) as assessed by DEXA from baseline at Days 90 and 180 following the G4LP and supplementation with Release.
The change in android/gynoid fat ratio as assessed by DEXA from baseline at Days 90 and 180 following the G4LP and supplementation with Release.
The change in arm circumference from baseline at Days 90 and 180 following the G4LP and supplementation with Release.
+20 moreOther outcome measures
Clinically relevant changes in alanine aminotransferase (ALT) after 180 days.
Clinically relevant changes in alkaline phosphatase (ALP) after 180 days.
Clinically relevant changes in aspartate aminotransferase (AST) after 180 days.
+17 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Golo for Life® Plan(G4LP) and Release SupplementExperimental Treatment1 Intervention
Participants will be instructed to use the resources provided and follow the G4LP for the duration of the study period. Participants will also take one capsule of Release three times a day, to be taken at the beginning of or during each meal, starting on Day 1. If a dose is missed before or during a meal, participants are instructed to take the dose as soon as they remember after the meal. Participants will be advised not to exceed three capsules daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Release
2023
Completed Phase 2
~90
Find a Location
Who is running the clinical trial?
KGK Science Inc.Industry Sponsor
78 Previous Clinical Trials
6,077 Total Patients Enrolled
2 Trials studying Obesity
109 Patients Enrolled for Obesity
GoloLead Sponsor
4 Previous Clinical Trials
231 Total Patients Enrolled
1 Trials studying Obesity
68 Patients Enrolled for Obesity
David Crowley, MDPrincipal InvestigatorKGK Science Inc.
35 Previous Clinical Trials
2,670 Total Patients Enrolled
1 Trials studying Obesity
95 Patients Enrolled for Obesity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic or have had bad reactions to the ingredients in the study medication.I have type 2 diabetes and am being treated with insulin.My kidneys and liver are currently stable, except I may have had kidney stones but have been symptom-free for 6 months.I have a thyroid condition and have been on a stable medication dose for 3+ months.I haven't had major surgery in the last 3 months and don't plan any during the study.I am unable to understand and give consent for treatment.I am between 18 and 65 years old.I cannot have children because I've had surgery or have been menopausal for over a year.I am not taking any medications or supplements that affect my weight or metabolism.I have had surgery to help me lose weight.I have a history of serious stomach or intestine diseases.You have a long-term condition that causes inflammation in your body, as determined by a special assessment.You have been using tobacco products regularly within the past 6 months and plan to continue using them during the study.You have had problems with drinking too much alcohol or using drugs in the past year.You have obesity caused by certain medical conditions like acromegaly or hypothalamic obesity, as determined by a special assessment.My only cancer was skin basal cell carcinoma, fully removed, or any cancer I had is in remission for over 5 years.You have or had an eating disorder, as determined by a special questionnaire.Your body mass index (BMI) is between 25 and 39.9, which means you are overweight or obese.I have had a gout flare-up within the last year.I use cannabis more than once a month but agree to stop during the study.You drink more than two alcoholic beverages per day on average.
Research Study Groups:
This trial has the following groups:- Group 1: Golo for Life® Plan(G4LP) and Release Supplement
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
May I be eligible to partake in this research experiment?
"Eligible participants in this trial must demonstrate signs of obesity and be within the specified age range (18 - 65). The clinical study seeks to recruit 100 individuals."
Answered by AI
Is enrollment for this trial currently open?
"From the clinical trials database, it is clear that this medical trial remains in need of participants. It was initially posted on April 20th2023 and has been amended as recently as April 25th2023."
Answered by AI
How many individuals are involved in this experimental research?
"Affirmative. The data available on the clinicaltrials.gov website mentions that recruitment for this trial is presently ongoing, with a first posting date of April 20th 2023 and an update from April 25th 2023. This research project requires 100 volunteers to be enrolled at two distinct medical sites."
Answered by AI
Does Golo for Life® Plan (G4LP) and Release Supplement present any potential risks to users?
"Due to the limited data available on the Golo for Life® Plan(G4LP) and Release Supplement, our team at Power has given it a rating of 2 out of 3 in terms of safety. This is because although there are some studies that have confirmed its safety, none have yet tested its efficacy."
Answered by AI
Is this trial accessible to elderly participants?
"The age range accepted for this medical trial is 18 to 65. For those outside of the specified parameters, there are 60 trials specifically for patients under the age of 18 and 223 studies dedicated to individuals over 65 years old."
Answered by AI
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