Pilot Study of GLY-LOW Supplementation in Postmenopausal Women With Obesity
Completed · Early Phase 1 · Has a placebo group
Conditions studied: Insulin Resistance, Obesity, Cardiovascular Diseases, Cognitive Impairment, Physical Disability, Depression, Inflammation, Hormone Deficiency, Physical Inactivity, Hyperlipidemias, Hypertension, Overeating
In brief
A combination of generally regarded as safe (GRAS) compounds named GLY-LOW, which included: alpha lipoic acid, pyridoxamine, nicotinamide, piperine and thiamine, were examined in pre-clinical experiments. GLY-LOW supplementation reduced caloric intake and increased insulin sensitivity in mice. In female mice, GLY-LOW supplementation reversed aging-related declines in female hormones. Studies in humans are needed to examine the feasibility, utility and efficacy of GLY-LOW supplementation in post-menopausal women with obesity toward improving aging-related impairments. The effect of GLY-LOW supplementation on these obesity and biological age-related impairments in post-menopausal adult female humans with obesity is unknown. We aim to translate the findings of GLY-LOW supplementation in animals to a cohort of healthy, postmenopausal females at birth with obesity by conducting a one-group, no-placebo comparer, pre post intervention clinical trial. Additionally, we propose to examine the specific effect of supplementation by GLY-LOW on biological aging via retina scan. The objectives of the proposed pilot study are: I. Conduct a 6-month pilot study to examine the feasibility, utility and efficacy of GLY-LOW supplementation in a total of 40 postmenopausal female born adults \> 55 years with obesity (≥ 30 BMI).
Key facts
- Study ID
- NCT06242535
- Run by
- Hoskinson Health and Wellness Clinic
- People needed
- 13
- Starts
- 2023-07-27
- Expected to finish
- 2024-05-31
- Last updated by the study team
- 2025-06-10
Who can join
Age: 56 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Post-menopausal (>1 year from last menstrual cycle) adult females (at birth) >55 years of age with obesity (BMI ≥ 30)
You may not qualify if…
- Males
- Adults not females at birth
- Adult females diagnosed with Gout
- Adult females receiving hormone replacement therapy (HRT)
- Adult females who are currently prescribed or received weight loss medications within the past 6 months, or currently enrolled in a defined weight loss program.
- Adult females with cardio-metabolic disease [e.g. cardiovascular disease (CVD), type 2 diabetes (T2DM), hypertension, h/o stroke etc.)] requiring any prescription medication.
- Adult females with other chronic immune, pulmonary, neurodegenerative or systemic disease requiring prescription medication
- Adult females with severe asthma based upon American Thoracic Society (ATS) standards and/or NIH guidelines.
- Adult females requiring monoclonal antibody or biological treatment
- Adult females diagnosed with an acute lower respiratory or GI infection within 2 weeks
- Adult females who are pregnant (would not qualify as post-menopausal) or nursing mothers
- Adult females reporting moderate to severe mental or physical disability
- Adult females reporting unwillingness to travel to onsite clinical facilities
- Adult females with moderate to severe cognitive impairment
- Adult females diagnosed with an eating disorder
- Adult females on blood thinners and anti-platelet drugs (other than aspirin), on chronic steroids (including inhaled), on spironolactone, on statins, on diuretics, on chronic pain medications, on any medication that affects glucose, insulin, lipids, metabolic performance
- Adult females with any recent change in chronic disease or any recent change in medication.
- Adult females on supplements with potential to augment or compete with the GLY-LOW.
Where it is running
- Hoskinson Health and Wellness Clinic — Gillette, Wyoming, United States
Full record on ClinicalTrials.gov
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