GLY-LOW Supplementation for Obesity

Overseen By Melinda S Sothern, PhD

Age: 18+

Sex: Female

Trial Phase: Phase < 1

Sponsor: Hoskinson Health and Wellness Clinic

Must not be taking: Hormone therapy, Weight loss drugs

Disqualifiers: Gout, Cardio-metabolic disease, Severe asthma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a supplement called GLY-LOW, which combines several safe compounds, to address obesity and aging-related issues in postmenopausal women. Earlier studies with mice showed that GLY-LOW reduced calorie intake and improved insulin use. The trial aims to determine if these benefits apply to humans, focusing on improving obesity-related conditions and signs of aging. Women over 55, who have not had a menstrual cycle for over a year and have a BMI of 30 or higher, are suitable for this study. Participants will take the supplement daily for six months to assess its effects. As an Early Phase 1 trial, this research seeks to understand how GLY-LOW works in people, offering participants a chance to explore its potential benefits.

Will I have to stop taking my current medications?

Yes, you may need to stop taking certain medications. The trial excludes participants who are on various prescription medications, including those for chronic diseases, blood thinners, and supplements that might interact with GLY-LOW.

Is there any evidence suggesting that GLY-LOW supplementation is likely to be safe for humans?

Research shows that GLY-LOW contains ingredients like alpha lipoic acid and thiamine, which are generally considered safe. In animal studies, these ingredients reduced calorie intake and improved sugar metabolism. Although these results are promising, studies in humans are still needed to confirm safety and effectiveness.

Since this trial is in its early stages, the focus is on safety. The ingredients in GLY-LOW have been safely used in humans before, but this specific combination requires further study. This trial will help determine how well people tolerate it and what effects it might have. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike most treatments for obesity that focus on diet, exercise, or medications to suppress appetite, GLY-LOW is a daily oral supplement that is derived from compounds originally studied in mice. Researchers are excited about GLY-LOW because it offers a new way to potentially manage obesity by targeting the body's metabolic processes directly. This supplement stands out due to its unique formulation and ease of use, making it a promising option for those seeking an alternative to traditional weight loss methods.

What evidence suggests that GLY-LOW supplementation might be an effective treatment for obesity?

Research has shown that GLY-LOW supplements have promising effects in animal studies. In mice, the supplement reduced food intake and improved insulin use, a hormone that controls blood sugar. It also helped older female mice with hormone balance. The supplement contains safe ingredients like alpha lipoic acid and thiamine. Although human studies are still needed, these early findings suggest it might help with weight issues and aging in postmenopausal women. Participants in this trial will take the GLY-LOW supplement daily to evaluate its effects in humans. ^{1 2 3 5 6}

Who Is on the Research Team?

Sanjay Dhar, PhD

Principal Investigator

Hoskinson Health and Wellness Clinic

Are You a Good Fit for This Trial?

This trial is for postmenopausal women over the age of 55 with obesity (BMI > 30). Participants should be healthy but may have issues like high cholesterol, insulin resistance, or a sedentary lifestyle. The study excludes details on who can't join.

Inclusion Criteria

I am a woman over 55, post-menopausal for more than a year, and have a BMI of 30 or higher.

Exclusion Criteria

I am an adult female with a moderate to severe disability.

I am not willing to travel to a clinic for the study.

I am male.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

8 weeks

Multiple visits for screening and baseline evaluation

Baseline Evaluation

Baseline measurements and evaluations are conducted

4 weeks

In-person visits for baseline measurements

Treatment

Participants receive GLY-LOW supplementation daily for 6 months

24 weeks

Follow-up safety assessment visits every 2 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

Follow-up assessment after 6 months of treatment

What Are the Treatments Tested in This Trial?

Interventions

• GLY-LOW

Trial Overview The trial tests GLY-LOW, a supplement blend aimed at reducing caloric intake and improving insulin sensitivity and hormone levels in postmenopausal women. It's a one-group study without a placebo where effects are measured before and after 6 months of use.

How Is the Trial Designed?

Group I: GLY-LOW supplement Experimental Treatment 1 Intervention

Each participant will take this supplement daily in a pill form orally once in the morning. The test product will be two capsules a day with breakfast between 7:00 - 11:00 AM. The chosen doses were based on dose conversion from mice to humans and the prior data on safety for each of the compounds in humans.

Who Is Running the Clinical Trial?

Hoskinson Health and Wellness Clinic

Lead Sponsor

Trials

2

Recruited

80+

Buck Institute for Research on Aging

Collaborator

Trials

6

Recruited

1,200+

University of Wyoming

Collaborator

Trials

20

Recruited

1,600+

Published Research Related to This Trial

Obesity has more than doubled in the U.S. over the past 30 years, leading to increased risks for serious health issues like type 2 diabetes and certain cancers, highlighting the urgent need for effective treatment and prevention strategies.

Current treatment options for obesity include lifestyle changes, FDA-approved medications like sibutramine and orlistat, and bariatric surgery, but the review emphasizes the importance of evaluating the safety and efficacy of various weight-loss diets and over-the-counter supplements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A perspective on the current strategies for the treatment of obesity. Joyal, SV.[2019]

A meta-analysis of 14 randomized controlled trials found that long-term low glycemic index/load (GI/GL) diets significantly reduced fasting insulin levels and C-reactive protein, which are important markers for obesity-related health risks.

While low GI/GL diets showed benefits in reducing certain biomarkers, they also resulted in a significant decrease in fat-free mass, indicating a need for careful monitoring of body composition during such dietary interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term effects of low glycemic index/load vs. high glycemic index/load diets on parameters of obesity and obesity-associated risks: a systematic review and meta-analysis. Schwingshackl, L., Hoffmann, G.[2022]

A systematic review of 11 randomized control trials involving 634 children found that low glycemic index (LGI) and low glycemic load (LGL) diets did not lead to significant changes in body weight, BMI, or waist circumference compared to control diets.

The study suggests that LGI and LGL diets do not improve cardiometabolic or glucometabolic health markers in children with overweight or obesity, indicating a need for further research to explore their potential benefits against high glycemic index diets.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of a Low Glycemic Index/Load Diet on Cardiometabolic, Glucometabolic, and Anthropometric Indices in Children with Overweight or Obesity: A Systematic Review and Meta-Analysis. Kalaitzopoulou, I., Theodoridis, X., Kotzakioulafi, E., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06242535

NCT06242535 | Pilot Study of GLY-LOW Supplementation ... The effect of GLY-LOW supplementation on these obesity and biological age-related impairments in post-menopausal adult female humans with obesity is unknown. ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06242535/pilot-study-of-gly-low-supplementation-in-postmenopausal-women-with-obesity

Pilot Study of GLY-LOW Supplementation in ... GLY-LOW supplementation reduced caloric intake and increased insulin sensitivity in mice. In female mice, GLY-LOW supplementation reversed aging ...

3. nature.com nature.com/articles/s41598-025-20511-x

Metabolic impact of dietary glycine supplementation in ... This study demonstrates that glycine supplementation in individuals with severe obesity enhances the glycine conjugation detoxification pathway ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2211124725011933

Glycation-lowering compounds inhibit ghrelin signaling to ... Gly-Low supplementation in the diet reduces food consumption, decreases body weight while preserving muscle mass, improves insulin sensitivity, and increases ...

5. withpower.com withpower.com/trial/early-phase-1-cognitive-impairment-ci-6-2023-5829f

GLY-LOW Supplementation for Obesity · Info for Participants A meta-analysis of 14 randomized controlled trials found that long-term low glycemic index/load (GI/GL) diets significantly reduced fasting insulin levels and C ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11251212/

Reduced plasma glycine concentration in healthy and ... Gly supplementation generally seems safe, although a safe upper limit of intake still needs to be established [27]. It remains unclear whether the lower plasma ...