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Gly-low Cocktail for Obesity

VH
Overseen ByVictoria Hogue
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: University of California, San Francisco

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called Gly-low, which aims to help individuals with obesity reduce food intake and potentially lose weight. Researchers believe Gly-low can lower harmful substances in the body that contribute to sugar addiction and weight gain. Participants will receive either the Gly-low cocktail or a placebo (a sugar pill) to assess Gly-low's effectiveness. The trial seeks individuals with a BMI over 27 who are under the age of 50. As a Phase 1 and Phase 2 trial, this research focuses on understanding how Gly-low works in people and measuring its effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

In a previous study, researchers tested the Gly-low cocktail, a mix of five natural ingredients: alpha-lipoic acid, nicotinamide, thiamine, pyridoxamine, and piperine. These ingredients are generally considered safe, meaning most people can use them without problems.

The study found that Gly-low helped mice eat less and gain less weight. For humans, the study examined safety and early effects in postmenopausal women with obesity. The results showed that Gly-low was well-tolerated, with no major negative reactions reported.

Since this trial is in the early stages, the main goal is to learn more about safety. So far, evidence suggests that Gly-low is safe for people, but more research is needed to confirm this.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about Gly-low because it combines several active ingredients—alpha-lipoic acid, nicotinamide, thiamine, pyridoxamine, and piperine—to potentially tackle obesity in a novel way. Unlike standard treatments like lifestyle changes and medications such as orlistat or liraglutide, which often focus on reducing appetite or blocking fat absorption, Gly-low's unique mixture might target metabolic pathways more directly. This cocktail approach could enhance energy metabolism and reduce inflammation, offering a fresh angle on weight management that current treatments don't fully address.

What evidence suggests that Gly-low might be an effective treatment for obesity?

Research shows that Gly-low, a blend of natural ingredients, can reduce food intake and promote weight loss. In studies with mice, this treatment improved the body's response to insulin, the hormone that controls blood sugar. Gly-low also extended the lifespan of older mice, highlighting its potential benefits. Alpha-lipoic acid, a key ingredient, appears to decrease appetite, while other components aid in weight management. This trial will test the Gly-low cocktail, which includes alpha-lipoic acid, nicotinamide, thiamine, pyridoxamine, and piperine, against a placebo control. These findings suggest Gly-low could combat obesity by lowering calorie intake and boosting metabolism.13567

Who Is on the Research Team?

MS

Marshall Stoller, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for adults under 50 years old with obesity, defined as having a body mass index (BMI) over 27. It aims to test if a special cocktail of compounds can help reduce their appetite and lower markers related to insulin resistance.

Inclusion Criteria

I am obese with a BMI over 27.

Exclusion Criteria

I am under 50 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Baseline Assessment

Baseline measurements in body mass index (BMI), waist circumference, food intake, dietary behavior, urine, and serum will be obtained

1 week
1 visit (in-person)

Treatment

Participants receive Gly-low supplements or placebo daily, with BMI measured every 12 weeks and urine and serum analyzed for aging and metabolic markers

12 months
4 visits (in-person) every 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of frailty and cognition

4 weeks
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Gly-low
Trial Overview The study is testing 'Gly-low', a mix including alpha-lipoic acid, nicotinamide, thiamine, pyridoxamine, and piperine against a placebo. Gly-low has shown promise in reducing food intake and weight in animal studies and may influence aging pathways.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: InterventionExperimental Treatment1 Intervention
Group II: ControlPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials
2,636
Recruited
19,080,000+

Published Research Related to This Trial

Combination therapies for obesity treatment, such as pramlintide with phentermine and GLP-1 with glucagon, show promising efficacy beyond traditional diet and lifestyle changes.
Recent trials indicate that combining intragastric balloon treatments with GLP-1 analogs like liraglutide may enhance weight loss outcomes, suggesting a potential new direction for obesity management in clinical practice.
Combination Therapies for Obesity.Camilleri, M., Acosta, A.[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.
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]
Recent advancements in obesity drug therapy include new combinations of existing medications and higher doses of approved drugs, showing promise for effective weight management.
Despite the potential of these new drugs, challenges such as cost, patient acceptance, and the need for more evidence on long-term cardiovascular benefits remain significant barriers to their integration into clinical practice.
New medications for treatment of obesity: metabolic and cardiovascular effects.Pucci, A., Finer, N.[2017]

Citations

Methylglyoxal (MGO) Lowering Cocktail to Reduce ...The investigators demonstrated that methylglyoxal (MGO) derived Advanced Glycation Endproducts (AGEs) enhance food intake especially under a high sugar diet.
NCT06242535 | Pilot Study of GLY-LOW Supplementation ...GLY-LOW supplementation reduced caloric intake and increased insulin sensitivity in mice. In female mice, GLY-LOW supplementation reversed aging-related ...
Safety and Preliminary Effectiveness of a Natural, Multi-modal ...The present study aimed to evaluate the safety of a natural, multi-modal therapeutic and observe alterations in metabolic and aging-related outcomes in humans ...
GLYCATION-LOWERING COMBO EXTENDS LIFESPAN ...Administration of Gly-Low reduced food consumption and body weight, improving insulin sensitivity and survival in both leptin receptor deficient (Lepr db) and ...
Glycation-lowering compounds inhibit ghrelin signaling to ...These findings indicate that α-lipoic acid is the primary driver of appetite suppression, while nicotinamide and thiamine contribute to weight change through ...
Safety and Preliminary Effectiveness of a Natural, Multi- ...This study examines the safety and preliminary effectiveness of a natural, multi-modal therapeutic in postmenopausal women with obesity. This ...
Trial | NCT06242535A combination of generally regarded as safe (GRAS) compounds named GLY-LOW, which included: alpha lipoic acid, pyridoxamine, nicotinamide, piperine and ...
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