Gly-low Cocktail for Obesity

Overseen By Victoria Hogue

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of California, San Francisco

Disqualifiers: Age under 50

Compensation: Varies

Number of Visits: 7

Duration: 12 months

100 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment Gly-low for obesity?

The research suggests that combination therapies, including those with GLP-1 analogs like liraglutide, show promise in treating obesity. These combinations have been effective in weight loss and improving obesity-related health issues, indicating potential for similar treatments like Gly-low. ^{1 2 3 4 5}

Is Gly-low Cocktail safe for humans?

The Gly-low Cocktail, which may include ingredients like the alpha-amylase inhibitor from white beans, has been tested in clinical studies and shown to cause weight loss without serious side effects. Some mild stomach-related side effects have been reported but tend to decrease with continued use. ^{6 7 8 9 10}

How is the Gly-low treatment for obesity different from other treatments?

The Gly-low treatment is unique because it focuses on using low glycemic load foods, which help manage weight by reducing body fat and improving cholesterol and blood sugar levels. This approach is different from other treatments that may not emphasize the timing and type of carbohydrates consumed. ^{6 11 12 13 14}

Research Team

Marshall Stoller, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

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

Group II: Control Placebo Group 1 Intervention

sugar pill

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New medications for treatment of obesity: metabolic and cardiovascular effects. Pucci, A., Finer, N.[2017]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combination Therapies for Obesity. Camilleri, M., Acosta, A.[2019]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

New medications for treatment of obesity: metabolic and cardiovascular effects. [2017]

2. France pubmed.ncbi.nlm.nih.gov

Diets and drugs for weight loss and health in obesity - An update. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Combination Therapies for Obesity. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Treatment of obesity in 2015. [2018]

5. Netherlands pubmed.ncbi.nlm.nih.gov

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

6. Netherlands 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. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Validation of a food frequency questionnaire in the assessment of dietary glycemic index, glycemic load, and protein intake in pregnant women with obesity. [2023]

8. Spain pubmed.ncbi.nlm.nih.gov

Effect of a low glycemic load on body composition and Homeostasis Model Assessment (HOMA) in overweight and obese subjects. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Low glycaemic index and glycaemic load diets in adults with excess weight: Systematic review and meta-analysis of randomised clinical trials. [2022]

10. England pubmed.ncbi.nlm.nih.gov

A proprietary alpha-amylase inhibitor from white bean (Phaseolus vulgaris): a review of clinical studies on weight loss and glycemic control. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Fat-restricted low-glycemic index diet controls weight and improves blood lipid profile: A pilot study among overweight and obese adults in Southwest China. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Chronologically scheduled snacking with high-protein products within the habitual diet in type-2 diabetes patients leads to a fat mass loss: a longitudinal study. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Carbohydrate nutrition and development of adiposity during adolescence. [2017]

14. United States pubmed.ncbi.nlm.nih.gov

Serum Levels of sRAGE Are Associated with Body Measurements, but Not Glycemic Parameters in Patients with Prediabetes. [2022]