What is the mechanism of action of this treatment?

Common treatments for inflammation often target the reduction of oxidative stress and modulation of inflammatory pathways. Alpha lipoic acid acts as a potent antioxidant, reducing oxidative stress and inflammation. Pyridoxamine inhibits the formation of advanced glycation end-products (AGEs), which are linked to inflammation and tissue damage. Nicotinamide, a form of vitamin B3, has anti-inflammatory properties and supports cellular repair mechanisms. Piperine enhances the bioavailability of other compounds and has anti-inflammatory effects by inhibiting pro-inflammatory cytokines. Thiamine (vitamin B1) supports metabolic processes and reduces oxidative stress. These mechanisms are crucial for inflammation patients as they help reduce chronic inflammation, improve metabolic and hormonal functions, and potentially slow down aging-related impairments.

What side effects are associated with this type of intervention?

Alpha lipoic acid is generally well-tolerated but can cause gastrointestinal issues such as nausea and diarrhea. Pyridoxamine, a form of vitamin B6, may lead to sensory neuropathy if taken in excessive amounts. Nicotinamide, a form of vitamin B3, can cause liver toxicity at high doses. Piperine, an extract from black pepper, may cause gastrointestinal discomfort and interact with various medications by altering their metabolism. Thiamine, or vitamin B1, is usually safe but can cause allergic reactions in some individuals. Overall, while these components are generally safe at recommended doses, they can have side effects, particularly at higher doses or with prolonged use.

What prior FDA approvals exist?

The FDA has approved various treatments for inflammation, including non-steroidal anti-inflammatory drugs (NSAIDs) like diclofenac and ibuprofen, which reduce inflammation by inhibiting cyclooxygenase enzymes. Alpha lipoic acid, a component of the GLY-LOW supplementation, has been studied for its antioxidant and anti-inflammatory properties, particularly in diabetic neuropathy. Pyridoxamine and thiamine (vitamin B1) are B vitamins that have roles in reducing inflammation and supporting metabolic functions, though they are more commonly recognized for their nutritional benefits rather than as primary anti-inflammatory agents. Nicotinamide (vitamin B3) has been explored for its anti-inflammatory and skin-protective effects. Piperine, an alkaloid from black pepper, enhances the bioavailability of various compounds and has anti-inflammatory properties, though it is not specifically approved as an anti-inflammatory drug. Overall, while these components have recognized benefits, their combined effects in a formulation like GLY-LOW are still under investigation.

What other types of research exist?

Promising novel alternatives to GLY-LOW supplementation for inflammation patients include: 1) Eicosapentaenoic acid (EPA) from fish oils, which has shown benefits in reducing inflammation and improving metabolic outcomes. 2) Combination treatments involving antioxidants like α-lipoic acid and other agents targeting diabetic painful neuropathy, which have demonstrated synergistic effects in reducing nociception. 3) Vitamin D supplementation, particularly high-dose therapy, which has been effective in managing chronic pain and inflammation. 4) Omega-3 polyunsaturated fatty acids, which have been associated with improved clinical outcomes in various inflammatory conditions.

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GLY-LOW Supplementation for Obesity

Phase < 1

Waitlist Available

Led By Sanjay Dhar, PhD

Research Sponsored by Hoskinson Health and Wellness Clinic

Eligibility Criteria Checklist

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

Must have

Post-menopausal (>1 year from last menstrual cycle) adult females (>55 years of age) with obesity (BMI ≥ 30)

Be older than 18 years old

Must not have

Adult females reporting moderate to severe mental or physical disability

Adult females reporting unwillingness to travel to onsite clinical facilities

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during the screening/baseline visit and again during the 6-month follow-up visit.study participants will complete a 24hr food recall as recommended16. study personnel will download, process, and analyze the asa24 data per nci protocols

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a supplement called GLY-LOW, which combines several vitamins and natural compounds. It aims to help postmenopausal women over 55 with obesity by improving their metabolism and hormone levels. The study will check if GLY-LOW can reduce calorie intake and improve overall health.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Specific side effects aren't listed, but safety will be monitored throughout the trial including metabolic disease risk, cardiovascular health, physical function, cognitive function, inflammation levels, and biological aging.

Eligibility Criteria

Inclusion Criteria

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

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

Exclusion Criteria

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

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

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

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I am male.

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I am an adult female on hormone replacement therapy.

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I was not assigned female at birth.

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I am a woman who has had surgery to remove my ovaries.

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I am a woman diagnosed with Gout.

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I am a woman currently using weight loss medications or enrolled in a weight loss program.

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I am a woman taking prescription medicine for a heart-related metabolic condition.

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I am a woman with a chronic illness that needs prescription medicine.

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I am a woman in need of antibody or biological treatment.

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I am currently pregnant or breastfeeding.

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I am a woman with significant memory or thinking problems.

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I am a woman diagnosed with an eating disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during the screening/baseline visit and again during the 6-month follow-up visit.study participants will complete a 24hr food recall as recommended16. study personnel will download, process, and analyze the asa24 data per nci protocols

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during the screening/baseline visit and again during the 6-month follow-up visit.study participants will complete a 24hr food recall as recommended16. study personnel will download, process, and analyze the asa24 data per nci protocols

This trial's timeline: 3 weeks for screening, Varies for treatment, and during the screening/baseline visit and again during the 6-month follow-up visit.study participants will complete a 24hr food recall as recommended16. study personnel will download, process, and analyze the asa24 data per nci protocols for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Fasting Insulin (I) and Glucose (G)

Glycosylated Hemoglobin [Hemoglobin A1C (HBA1C)]

Insulin Resistance (IR)

Secondary study objectives

Biological Aging

Body Composition ) (lean mass, fat mass, bone density and area, central adiposity)

Cardiorespiratory Fitness

+14 more

Other study objectives

Safety Outcomes

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: GLY-LOW supplementExperimental Treatment1 Intervention

This supplement is available for over-the-counter purchase. Each capsule is a combination of vitamins and natural products: Vitamin B1 (100mg); Vitamin B6 (50mg); Niacin (200mg); Alpha Lipoic Acid (150mg); and Piperine (15mg). 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.

0 / 15Eligibility 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 inflammation often target the reduction of oxidative stress and modulation of inflammatory pathways. Alpha lipoic acid acts as a potent antioxidant, reducing oxidative stress and inflammation. Pyridoxamine inhibits the formation of advanced glycation end-products (AGEs), which are linked to inflammation and tissue damage. Nicotinamide, a form of vitamin B3, has anti-inflammatory properties and supports cellular repair mechanisms. Piperine enhances the bioavailability of other compounds and has anti-inflammatory effects by inhibiting pro-inflammatory cytokines. Thiamine (vitamin B1) supports metabolic processes and reduces oxidative stress. These mechanisms are crucial for inflammation patients as they help reduce chronic inflammation, improve metabolic and hormonal functions, and potentially slow down aging-related impairments.

Resveratrol and inflammation: Challenges in translating pre-clinical findings to improved patient outcomes.