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Type 2 DiabetesPhase 2NCT05844644

The Effects of the GOLO for Life® Plan With Release Supplement on Glycemic Control and Weight in Overweight and Obese Adults With Prediabetes or Type 2 Diabetes

A Phase 2 study testing Release in people with Type 2 Diabetes and Obese, run by Golo at 2 sites in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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 glycemic control and weight in overweight and obese adults with Prediabetes or Type 2 Diabetes. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Type 2 Diabetes, 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
100 participants
Where
2 sitesCanada
Study dates
20 Apr 2023to Jan 2025
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males and females between the age of 18-75 years, inclusive, at screening
  • BMI ≥25 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 17Show 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
  • Prediabetes or Type 2 Diabetes with HbA1c ≥6.0% to <9% with stability of disease and no change in diabetic medication in the past three months, if applicable.
  • Self-reported stable body weight in the three months prior to baseline, as assessed by the QI
  • Motivated and ability to comply with G4LP guidelines as assessed by a Self-Motivation Questionnaire at screening (see Appendix 16.3)
  • 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
  • Type 1 diabetes
  • Type 2 diabetes if on insulin treatment
  • Gastric bypass surgery or other surgeries to induce weight loss
  • Current participation or participation within the last three months in any weight loss or diet programs
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  • Current or history of eating disorders, as assessed by the QI
  • 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
  • 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 glycemic control, 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.

Marc Moulin, PhD contact

1-226-781-9094 ext. 300

mmoulin@kgkscience.com

KGK Science Inc. contact

participate@kgkscience.com

Canada2 sites, 2 recruiting

  • One Retreat Wellness

    LaSalle, Ontario, N9H 1S4

    Marc Moulin, PhD

    David Crowley, MD

    Recruiting

  • KGK Science Inc.

    London, Ontario, N6B 3L1

    Marc Moulin, 1-226-781-9094 ext. 300, mmoulin@kgkscience.com

    David Crowley, MD

    Recruiting

Other trials in Canada

About this study

Official title: An Open Label Study Evaluating the Effects of the GOLO for Life® Plan With Release Supplement on Glycemic Control and Weight in Overweight and Obese Adults With Prediabetes or Type 2 Diabetes

The objective of this study is to investigate the efficacy and safety of the GOLO for Life® Plan (G4LP) and Release supplementation on glycemic control and weight in overweight and obese adults with Prediabetes or Type 2 Diabetes. The change in glycemic control from baseline at Days 90 and 180 following the G4LP and supplementation with Release will be assessed. 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).

Being tested
Release
Keywords
Type 2 Diabetes, obese, overweight, glycemic control, Prediabetes
Medical subject headings
Diabetes Mellitus, Type 2, Obesity, Overweight, Prediabetic State

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 groups in NCT05844644
Study groupRoleWhat they receive
GOLO for Life® Plan (G4LP) and Release SupplementExperimentalParticipants 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.

  1. The change in glycemic control as measured by serum glucose levels from baseline at Days 90 and 180 following the G4LP and supplementation with Release.

    Measured: baseline, day 90, day 180

  2. The change in glycemic control as measured by HbA1c from baseline at Days 90 and 180 following the G4LP and supplementation with Release.

    Measured: baseline, day 90, day 180

  3. The change in glycemic control as measured by insulin from baseline at Days 90 and 180 following the G4LP and supplementation with Release.

    Measured: baseline, day 90, day 180

  4. The change in glycemic control as measured by HOMA-IR from baseline at Days 90 and 180 following the G4LP and supplementation with Release.

    Measured: baseline, day 90, day 180

  5. The change in glycemic control as measured by change in weight (kilograms) from baseline at Days 90 and 180 following the G4LP and supplementation with Release.

    Measured: baseline, day 90, day 180

  6. The change in glycemic control as measured by change in weight (percentage of total weight) from baseline at Days 90 and 180 following the G4LP and supplementation with Release.

    Measured: baseline, day 90, day 180

Secondary outcomes (11)

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. The change in lipid levels from baseline at days 90 and 180 following the G4LP and supplementation with Release.

    Measures of lipid levels to be assessed include 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

  9. 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

  10. The change in inflammatory markers from baseline at days 90 and 180 following the G4LP and supplementation with Release.

    Inflammatory markers to be measured include high sensitivity C-reactive protein (hsCRP), erythrocyte sedimentation rate (ESR), interleukin 6 (IL-6), and tumor necrosis factor alpha (TNF-α).

    Measured: baseline, day 90, day 180

  11. The change in quality of life from baseline at days 90 and 180 following the G4LP and supplementation with Release.

    Quality of life will be assessed by the RAND Corporation Short Form (SF)-36 questionnaire.

    Measured: baseline, day 90, day 180

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2023
  2. Study start20 Apr 2023
  3. Primary completionNov 2024 (estimated)
  4. Study completionJan 2025 (estimated)

Resources

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
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05844644
Sponsor's protocol ID
22GLCFG02
Status last verified
Jul 2024
First submitted
13 Apr 2023
Last updated
26 Jul 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Release in people with Type 2 Diabetes and Obese, 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 17 inclusion and 25 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: status not confirmed, as of the sponsor's last update on 26 Jul 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Marc Moulin, PhD (1-226-781-9094 ext. 300, mmoulin@kgkscience.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The change in glycemic control as measured by serum glucose levels from baseline at Days 90 and 180 following the G4LP and supplementation with Release. (time frame: baseline, day 90, day 180). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05844644.

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 26 Jul 2024.

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