Pilot Study of GLY-LOW Supplementation in Postmenopausal Women With Obesity (NCT06242535) | Clinical Trial Compass
CompletedEarly Phase 1
Pilot Study of GLY-LOW Supplementation in Postmenopausal Women With Obesity
United States13 participantsStarted 2023-07-27
Plain-language summary
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).
Who can participate
Age range
56 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Post-menopausal (\>1 year from last menstrual cycle) adult females (at birth) \>55 years of age with obesity (BMI ≥ 30)
Exclusion Criteria:
* 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 (inclu…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Insulin Resistance (IR)
Timeframe: During the screening/baseline visit and again during the 6-month follow-up visit.
2
Fasting Insulin (I) and Glucose (G)
Timeframe: During the screening/baseline visit and again during the 6-month follow-up visit.
3
Glycosylated Hemoglobin [Hemoglobin A1C (HBA1C)]
Timeframe: During the screening/baseline visit and again during the 6-month follow-up visit.
4
BMI [weight (kg) divided by height (m2)]
Timeframe: During the screening/baseline visit and again during the 6-month follow-up visit.
5
Body Composition [lean mass, fat mass, bone density and area, central adiposity (DEXA); waist circumference]
Timeframe: During the screening/baseline visit and again during the 6-month follow-up visit.