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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 is a Early Phase 1 study that has completed, run by Hoskinson Health and Wellness Clinic. The registered enrollment target is 13 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06242535
The ClinicalTrials.gov registry entry for NCT06242535 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoskinson Health and Wellness Clinic, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which GLY-LOW is the first listed.
NCT06242535 reports 0 study locations.
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.
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