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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 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.

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.

Find a Location

Who is running the clinical trial?

Buck Institute for Research on AgingOTHER
4 Previous Clinical Trials
1,110 Total Patients Enrolled
Hoskinson Health and Wellness ClinicLead Sponsor
1 Previous Clinical Trials
40 Total Patients Enrolled
University of WyomingOTHER
17 Previous Clinical Trials
1,397 Total Patients Enrolled
~13 spots leftby Jul 2025
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