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NCT06242535 · ClinicalTrials.gov registry record · Early Phase 1
Pilot Study of GLY-LOW Supplementation in Postmenopausal Women With Obesity
A Early Phase 1 study, sponsored by Hoskinson Health and Wellness Clinic.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 13
- Enrollment target
NCT06242535: Completed Early Phase 1 study, sponsored by Hoskinson Health and Wellness Clinic.
NCT06242535 is a Early Phase 1 study that has completed, run by Hoskinson Health and Wellness Clinic. The registered enrollment target is 13 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06242535, a Early Phase 1 study, has completed, sponsored by Hoskinson Health and Wellness Clinic.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 13 participants
- Enrollment target
Study 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).
Primary Outcome
Measured by examining biochemical markers using samples of whole blood obtained in a certified laboratory. . Study participants will be required to fast for 12 hours prior to the blood test. Blood collection and processing: Venous blood will be collected in the morning after a 12 hour fast with the study participant seated. Blood will be collected in tubes containing 1.5 mg/ml EDTA for procedures requiring plasma, in tubes with no additives for serum measures and citrate tubes for homeostasis en
Interventions
- BIOLOGICAL GLY-LOW
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2023-07-27 |
| Est. Completion | 2024-05-31 |
| Phase | Early Phase 1 |
What the finished NCT06242535 record still lists
NCT06242535 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 1 intervention - of which GLY-LOW is the first listed.
NCT06242535 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06242535 about?
NCT06242535 is a clinical study titled "Pilot Study of GLY-LOW Supplementation in Postmenopausal Women With Obesity". 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 fe...
What is the current status of trial NCT06242535?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 13 participants. The study started on 2023-07-27. Estimated completion is 2024-05-31.
What interventions are being tested in trial NCT06242535?
The interventions under investigation include: GLY-LOW (BIOLOGICAL).
Who is sponsoring clinical trial NCT06242535?
This trial is sponsored by Hoskinson Health and Wellness Clinic, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06242535's enrollment target sits among peer trials
13 1503rd of 2000 higher than 472 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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