What is the mechanism of action of this treatment?

Common treatments for obesity include pharmacologic agents like GLP-1 receptor agonists (e.g., semaglutide, liraglutide), which promote weight loss by enhancing satiety and reducing appetite. Dietary interventions, such as low-carbohydrate or Mediterranean diets, focus on macronutrient composition to reduce caloric intake and improve metabolic health. Exercise increases insulin sensitivity and energy expenditure. The Gly-low cocktail, which lowers methylglyoxal (MGO) levels, aims to reduce food intake and weight gain by targeting the molecular pathways that drive sugar addiction. Understanding these mechanisms helps obesity patients and their doctors choose the most effective treatment tailored to their metabolic and behavioral needs.

What side effects are associated with this type of intervention?

Common treatments for obesity include medications like orlistat, GLP-1 agonists, and combination therapies such as phentermine-topiramate. Orlistat is known to cause gastrointestinal side effects, including increased fecal fat excretion and potential discomfort. GLP-1 agonists, such as liraglutide, can lead to gastrointestinal issues like nausea and vomiting but are generally well-tolerated. Combination therapies may have varied side effects depending on the specific drugs used. The Gly-low trial, which involves a cocktail of compounds like alpha-lipoic acid and nicotinamide, aims to reduce food intake and weight, but specific side effects for this combination are not detailed in the provided context.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of obesity, including GLP-1 receptor agonists like liraglutide and extended-release exenatide, which are also used in type 2 diabetes management. These drugs help with weight loss by enhancing satiety and reducing food intake. While the Gly-low trial focuses on a methylglyoxal (MGO) lowering cocktail to reduce appetite and weight gain, there is no direct mention of FDA-approved treatments specifically targeting MGO. However, the general approach of using pharmacological agents to influence metabolic pathways and reduce food intake is a common strategy in obesity treatment.

What other types of research exist?

Promising novel alternatives to Gly-low for obesity treatment include: 1) Liraglutide, a GLP-1 receptor agonist, which has shown superior cardiometabolic benefits and weight loss in clinical trials. 2) Combined PYY3-36 and liraglutide therapy, which has demonstrated sustained weight loss comparable to Roux-en-Y gastric bypass in preclinical studies. 3) CDCA (Chenodeoxycholic acid), which has been shown to increase GLP-1 secretion and may aid in weight management post-Roux-en-Y gastric bypass.

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Gly-low Cocktail for Obesity

Phase 1 & 2

Waitlist Available

Led By Marshall Stoller, MD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Obese individuals with BMI >27

Be older than 18 years old

Must not have

Must be younger than 50 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 1 year

Summary

This trial tests a pill called Gly-low, which is a mix of five safe compounds. It aims to help adults aged 50-70 with obesity by reducing harmful sugar-related compounds in their bodies. The goal is to lower food intake, weight gain, and improve overall health.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not detailed but could include reactions to the ingredients like stomach upset or allergic responses. Since it affects metabolic pathways, there might be changes in energy levels or other metabolic disturbances.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am obese with a BMI over 27.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am under 50 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and one year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and one year

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and one year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in body mass index (BMI) from baseline to 1 year

Change in frailty from baseline to 1 year

Cognition

Secondary study objectives

Blood Marker Glucose for Aging and Insulin Resistance

Other study objectives

Elder Abuse

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: InterventionExperimental Treatment1 Intervention

MGO cocktail containing a combination of alpha-lipoic acid, nicotinamide, thiamine, pyridoxamine, and piperine

Group II: ControlPlacebo Group1 Intervention

sugar pill

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for obesity include pharmacologic agents like GLP-1 receptor agonists (e.g., semaglutide, liraglutide), which promote weight loss by enhancing satiety and reducing appetite. Dietary interventions, such as low-carbohydrate or Mediterranean diets, focus on macronutrient composition to reduce caloric intake and improve metabolic health. Exercise increases insulin sensitivity and energy expenditure. The Gly-low cocktail, which lowers methylglyoxal (MGO) levels, aims to reduce food intake and weight gain by targeting the molecular pathways that drive sugar addiction. Understanding these mechanisms helps obesity patients and their doctors choose the most effective treatment tailored to their metabolic and behavioral needs.