ObesePhase 2NCT05844631
The Effects of the GOLO for Life® Plan and Release Supplement on Weight Management in Overweight and Obese Adults
A Phase 2 study testing Release in people with Obese and Overweight, run by Golo at 2 sites in Canada.
Trial summary
The objective of this study is to investigate the efficacy and safety of the GOLO for Life® Plan (G4LP) and Release supplementation on weight loss, body composition, and cardiometabolic parameters in overweight and obese adults. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obese, Overweight
- What is being tested?
- Release
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 2 sitesCanada
- Study dates
- 20 Apr 2023to 23 Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females between the age of 18-65 years, inclusive, at screening
- BMI between 25 and 39.9 kg/m2
- 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
- Or,
- Individuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months prior to enrollment. Acceptable methods of birth control include:
- Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
Show all 16Show fewer
- Double-barrier method
- Intrauterine devices
- Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
- Vasectomy of partner at least 6 months prior to screening
- Abstinence and agrees to use contraception if planning on becoming sexually active
- Self-reported stable body weight defined as not having gained or lost more than 5 kg of body weight in the three months prior to baseline
- Motivated and ability to comply with G4LP guidelines as assessed by a Self-Motivation Questionnaire at screening (see Appendix 16.2)
- Agrees to maintain current lifestyle habits as much as possible throughout the study depending on ability to maintain the following: medications, supplements (unless excluded), and sleep
- Willingness and ability to complete questionnaires, records, and diaries associated with the study, adhere to dietary and exercise guidelines, and to complete all clinic visits
- Provided voluntary, written, informed consent to participate in the study
Who cannot join
- Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
- Allergy, sensitivity, or intolerance to the investigational product ingredients
- Gastric bypass surgery or other surgeries to induce weight loss
- Metal implants or other physical characteristics/limitations that may affect DEXA scan results, as assessed by the QI
- Current participation within the last three months in any weight loss or diet programs
- Current or history of eating disorders, as assessed by the QI
Show all 26Show fewer
- Obesity-induced by metabolic or endocrinologic disorders (ex. acromegaly, hypothalamic obesity), as assessed by the QI
- Current or history of significant diseases of the gastrointestinal tract, as assessed by the QI
- Chronic inflammatory diseases, as assessed by the QI
- Type I diabetes
- Type 2 diabetes if on insulin treatment
- History of gout and have had a flare up within 12 months, as assessed by the QI
- Current unstable diagnosis with kidney and/or liver diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones in participants who are symptom free for 6 months
- Self-reported confirmation of current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
- Major surgery in the past 3 months or individuals who have planned surgery during the course of the study. Participants with minor surgery will be considered on a case-by-case basis by the QI
- Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable
- Current use of any prescribed or over-the counter medications and/or supplements that may affect body weight or metabolism, as assessed by the QI
- Regular use of tobacco products within 6 months of baseline and during the study period, as assessed by the QI
- Chronic inhalation and edible use of cannabinoid products (>1 time/month). Occasional users must agree to wash out and abstain during the study period
- Alcohol intake average of >2 standard drinks per day
- Alcohol or drug abuse within the last 12 months
- Clinically significant abnormal laboratory results at screening, as assessed by the QI
- Blood donation 30 days prior to baseline, during the study, or a planned donation within 30 days of the last study visit
- Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI
- Individuals who are unable to give informed consent
- Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
One Retreat Wellness
LaSalle, Ontario, N9H 1S4
KGK Science Inc.
London, Ontario, N6B 3L1
About this study
Official title: An Open-label Study Evaluating the Effects of the GOLO for Life® Plan and Release Supplement on Weight Management in Overweight and Obese Adults
The objective of this study is to investigate the efficacy and safety of the GOLO for Life® Plan (G4LP) and Release supplementation on weight loss, body composition, and cardiometabolic parameters in overweight and obese adults. The change from baseline at Days 90 and 180 following the G4LP and supplementation with Release in weight (kg and % of total weight) and fat mass (percent and kg) will be assessed by Dual X-Ray Absorptiometry (DEXA). The weekly change in weight (kilograms and percent change) will also be assessed from baseline to day 180 following the G4LP and Release supplementation. Additionally, the safety and tolerability of the G4LP and Release supplementation will be measured by the occurrence of and/or changes in pre-emergent and post-emergent adverse events (AEs).
- Conditions
- Obese, Overweight
- Being tested
- Release
- Keywords
- overweight, obese, weight loss, body composition, cardiometabolic parameters
- Medical subject headings
- Obesity, Overweight, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReleaseDietary supplement
One capsule of Release will be taken three times per day for 180 days in combination with the G4LP.
| Study group | Role | What they receive |
|---|---|---|
| Golo for Life® Plan(G4LP) and Release Supplement | Experimental | 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. Receives: Dietary Supplement: Release |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in weight (kilograms) following the GOLO for Life® Plan (G4LP) and supplementation with Release.
Change in weight will be assessed by Dual X-Ray Absorptiometry (DEXA).
Measured: baseline, day 90, day 180
The change in weight (percentage of total weight) following the GOLO for Life® Plan (G4LP) and supplementation with Release.
Change in weight will be assessed by Dual X-Ray Absorptiometry (DEXA).
Measured: baseline, day 90, day 180
The change in fat mass (percent) following the GOLO for Life® Plan (G4LP) and supplementation with Release.
Change in fat mass will be assessed by Dual X-Ray Absorptiometry (DEXA).
Measured: baseline, day 90, day 180
The change in fat mass (kilograms) following the GOLO for Life® Plan (G4LP) and supplementation with Release.
Change in fat mass will be assessed by Dual X-Ray Absorptiometry (DEXA).
Measured: baseline, day 90, day 180
Secondary outcomes (23)
The change in body mass index (BMI) from baseline at Days 90 and 180 following the G4LP and supplementation with Release.
Measured: baseline, day 90, day 180
The change in muscle mass (percent) as assessed by DEXA from baseline at Days 90 and 180 following the G4LP and supplementation with Release.
Measured: baseline, day 90, day 180
The change in android fat (percent) as assessed by DEXA from baseline at Days 90 and 180 following the G4LP and supplementation with Release.
Measured: baseline, day 90, day 180
The change in gynoid fat (percent) as assessed by DEXA from baseline at Days 90 and 180 following the G4LP and supplementation with Release.
Measured: baseline, day 90, day 180
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.
Measured: baseline, day 90, day 180
The change in sagittal abdominal diameter (SAD) from baseline at Days 90 and 180 following the G4LP and supplementation with Release.
Measured: baseline, day 90, day 180
The change in waist circumference from baseline at Days 90 and 180 following the G4LP and supplementation with Release.
Measured: baseline, day 90, day 180
The change in hip circumference from baseline at Days 90 and 180 following the G4LP and supplementation with Release.
Measured: baseline, day 90, day 180
The change in arm circumference from baseline at Days 90 and 180 following the G4LP and supplementation with Release.
Measured: baseline, day 90, day 180
The change in thigh circumference from baseline at Days 90 and 180 following the G4LP and supplementation with Release.
Measured: baseline, day 90, day 180
The change in waist-to-hip ratio from baseline at Days 90 and 180 following the G4LP and supplementation with Release.
Measured: baseline, day 90, day 180
The change in lipid levels from baseline at Days 90 and 180 following the G4LP and supplementation with Release.
Lipid levels will be assessed by triglycerides (TG), total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), non-HDL-C, low-density lipoprotein cholesterol (LDL-C), TC:HDL-C, TG:HDL-C, and LDL-C:HDL-C ratios
Measured: baseline, day 90, day 180
The change in glycemic control as assessed by HbA1c from baseline at Days 90 and 180 following the G4LP and supplementation with Release.
Measured: baseline, day 90, day 180
The change in glycemic control as assessed by serum insulin from baseline at Days 90 and 180 following the G4LP and supplementation with Release.
Measured: baseline, day 90, day 180
The change in glycemic control as assessed by serum glucose from baseline at Days 90 and 180 following the G4LP and supplementation with Release.
Measured: baseline, day 90, day 180
The change in glycemic control as assessed by HOMA-IR from baseline at Days 90 and 180 following the G4LP and supplementation with Release.
Measured: baseline, day 90, day 180
The change in blood pressure from baseline at Days 90 and 180 following the G4LP and supplementation with Release.
Measured: baseline, day 90, day 180
The change in gastrointestinal symptoms from baseline at Days 90 and 180 following the G4LP and supplementation with Release.
Gastrointestinal symptoms will be assessed by the Modified Gastrointestinal Symptoms Rating Scale (GSRS)
Measured: baseline, day 90, day 180
The change in subjective sleep efficiency, sleep debt, and sleep difficulty from baseline at Days 90 and 180 following the G4LP and supplementation with Release.
Changes in sleep will be assessed by the Healthy People Sleep Quality Index (HPSQI).
Measured: baseline, day 90, day 180
The change in stress levels from baseline at Days 90 and 180 following the G4LP and supplementation with Release.
Stress levels will be assessed by the Perceived Stress Scale (PSS) and salivary cortisol.
Measured: baseline, day 90, day 180
The change in physical activity from baseline at Days 90 and 180 following the G4LP and supplementation with Release.
Physical activity will be assessed by the International Physical Activity Questionnaire (IPAQ).
Measured: baseline, day 90, day 180
The weekly change in weight (kilogram) from baseline at Day 180 following the G4LP and supplementation with Release.
Measured: baseline to day 180
The weekly change in weight (percentage) from baseline at Day 180 following the G4LP and supplementation with Release.
Measured: baseline to day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start20 Apr 2023
- Primary completion23 Dec 2023
- Study completion23 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObeseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Golo
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Responsible party
- Sponsor
- Investigators
- David Crowley, MD, Principal investigator, KGK Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05844631
- Sponsor's protocol ID
- 22GLCFG01
- Status last verified
- Feb 2024
- First submitted
- 13 Apr 2023
- Last updated
- 12 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Study Evaluating the Effects of the GOLO for Life® Plan and Release Supplement on Weight Management in Overweight and Obese Adults
- ClinicalTrials.gov ID
- NCT05844631
- Acronym / sponsor ID
- 22GLCFG01
- Conditions
- Obese, Overweight
- Keywords
- overweight, obese, weight loss, body composition, cardiometabolic parameters
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- GoloIndustry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- 23 Dec 2023 (actual)
- Study completion
- 23 Dec 2023 (actual)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to investigate the efficacy and safety of the GOLO for Life® Plan (G4LP) and Release supplementation on weight loss, body composition, and cardiometabolic parameters in overweight and obese adults. The change from baseline at Days 90 and 180 following the G4LP and supplementation with Release in weight (kg and % of total weight) and fat mass (percent and kg) will be assessed by Dual X-Ray Absorptiometry (DEXA). The weekly change in weight (kilograms and percent change) will also be assessed from baseline to day 180 following the G4LP and Release supplementation. Additionally, the safety and tolerability of the G4LP and Release supplementation will be measured by the occurrence of and/or changes in pre-emergent and post-emergent adverse events (AEs).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Golo for Life® Plan(G4LP) and Release Supplement | Experimental | Dietary Supplement: ReleaseParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Males and females between the age of 18-65 years, inclusive, at screening
- BMI between 25 and 39.9 kg/m2
- 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
- Or,
- Individuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months prior to enrollment. Acceptable methods of birth control include:
Key exclusion criteria (26 listed)
- Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
- Allergy, sensitivity, or intolerance to the investigational product ingredients
- Gastric bypass surgery or other surgeries to induce weight loss
- Metal implants or other physical characteristics/limitations that may affect DEXA scan results, as assessed by the QI
- Current participation within the last three months in any weight loss or diet programs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReleaseOne capsule of Release will be taken three times per day for 180 days in combination with the G4LP. | Dietary supplement | Golo for Life® Plan(G4LP) and Release Supplement |
Primary outcome
The change in weight (kilograms) following the GOLO for Life® Plan (G4LP) and supplementation with Release.
Time frame: baseline, day 90, day 180
Change in weight will be assessed by Dual X-Ray Absorptiometry (DEXA).
The change in weight (percentage of total weight) following the GOLO for Life® Plan (G4LP) and supplementation with Release.
Time frame: baseline, day 90, day 180
Change in weight will be assessed by Dual X-Ray Absorptiometry (DEXA).
The change in fat mass (percent) following the GOLO for Life® Plan (G4LP) and supplementation with Release.
Time frame: baseline, day 90, day 180
Change in fat mass will be assessed by Dual X-Ray Absorptiometry (DEXA).
The change in fat mass (kilograms) following the GOLO for Life® Plan (G4LP) and supplementation with Release.
Time frame: baseline, day 90, day 180
Change in fat mass will be assessed by Dual X-Ray Absorptiometry (DEXA).
23 secondary outcomes
The change in body mass index (BMI) from baseline at Days 90 and 180 following the G4LP and supplementation with Release.
Time frame: baseline, day 90, day 180
The change in muscle mass (percent) as assessed by DEXA from baseline at Days 90 and 180 following the G4LP and supplementation with Release.
Time frame: baseline, day 90, day 180
The change in android fat (percent) as assessed by DEXA from baseline at Days 90 and 180 following the G4LP and supplementation with Release.
Time frame: baseline, day 90, day 180
The change in gynoid fat (percent) as assessed by DEXA from baseline at Days 90 and 180 following the G4LP and supplementation with Release.
Time frame: baseline, day 90, day 180
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.
Time frame: baseline, day 90, day 180
The change in sagittal abdominal diameter (SAD) from baseline at Days 90 and 180 following the G4LP and supplementation with Release.
Time frame: baseline, day 90, day 180
The change in waist circumference from baseline at Days 90 and 180 following the G4LP and supplementation with Release.
Time frame: baseline, day 90, day 180
The change in hip circumference from baseline at Days 90 and 180 following the G4LP and supplementation with Release.
Time frame: baseline, day 90, day 180
The change in arm circumference from baseline at Days 90 and 180 following the G4LP and supplementation with Release.
Time frame: baseline, day 90, day 180
The change in thigh circumference from baseline at Days 90 and 180 following the G4LP and supplementation with Release.
Time frame: baseline, day 90, day 180
The change in waist-to-hip ratio from baseline at Days 90 and 180 following the G4LP and supplementation with Release.
Time frame: baseline, day 90, day 180
The change in lipid levels from baseline at Days 90 and 180 following the G4LP and supplementation with Release.
Time frame: baseline, day 90, day 180
The change in glycemic control as assessed by HbA1c from baseline at Days 90 and 180 following the G4LP and supplementation with Release.
Time frame: baseline, day 90, day 180
The change in glycemic control as assessed by serum insulin from baseline at Days 90 and 180 following the G4LP and supplementation with Release.
Time frame: baseline, day 90, day 180
The change in glycemic control as assessed by serum glucose from baseline at Days 90 and 180 following the G4LP and supplementation with Release.
Time frame: baseline, day 90, day 180
The change in glycemic control as assessed by HOMA-IR from baseline at Days 90 and 180 following the G4LP and supplementation with Release.
Time frame: baseline, day 90, day 180
The change in blood pressure from baseline at Days 90 and 180 following the G4LP and supplementation with Release.
Time frame: baseline, day 90, day 180
The change in gastrointestinal symptoms from baseline at Days 90 and 180 following the G4LP and supplementation with Release.
Time frame: baseline, day 90, day 180
The change in subjective sleep efficiency, sleep debt, and sleep difficulty from baseline at Days 90 and 180 following the G4LP and supplementation with Release.
Time frame: baseline, day 90, day 180
The change in stress levels from baseline at Days 90 and 180 following the G4LP and supplementation with Release.
Time frame: baseline, day 90, day 180
The change in physical activity from baseline at Days 90 and 180 following the G4LP and supplementation with Release.
Time frame: baseline, day 90, day 180
The weekly change in weight (kilogram) from baseline at Day 180 following the G4LP and supplementation with Release.
Time frame: baseline to day 180
The weekly change in weight (percentage) from baseline at Day 180 following the G4LP and supplementation with Release.
Time frame: baseline to day 180
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Crowley, MD principal investigator
KGK Science Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Release in people with Obese and Overweight, run by Golo at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in weight (kilograms) following the GOLO for Life® Plan (G4LP) and supplementation with Release. (time frame: baseline, day 90, day 180). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2024.