NCT06242535CompletedEarly phase 1
Pilot Study of GLY-LOW Supplementation in Postmenopausal Women With Obesity
Source: ClinicalTrials.gov · Last updated 10 Jun 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 13 (actual)
- First submitted
- 29 Jan 2024
- Start date
- 27 Jul 2023
- Primary completion date
- 31 May 2024
- Lead sponsor
- Hoskinson Health and Wellness Clinic
- Diseases
- Obesity, High blood pressure
- NCT number
- NCT06242535
What you commit to
- Study type: Interventional · Early phase 1
- Participants enrolled: 13
- From 27 Jul 2023 to the primary completion date, 31 May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 requiring monoclonal antibody or biological treatment
Other illness
- 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 diagnosed with an acute lower respiratory or GI infection within 2 weeks
- Adult females with moderate to severe cognitive impairment
- Adult females diagnosed with an eating disorder
- Adult females with any recent change in chronic disease or any recent change in medication.
Lab values
- 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
Other
- Males
- Adults not females at birth
- Adult females diagnosed with Gout
- Adult females with severe asthma based upon American Thoracic Society (ATS) standards and/or NIH guidelines.
- 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 on supplements with potential to augment or compete with the GLY-LOW.
Who the study is looking for
- Post-menopausal (\>1 year from last menstrual cycle) adult females (at birth) \>55 years of age with obesity (BMI ≥ 30)
Age in the registry: 56 years to - · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hoskinson Health and Wellness Clinic Coordinator of this site? Confirm its status | Gillette | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.