NCT06242535 — drugset

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).

Timeline

Start: 2023-07-27
Primary completion: 2024-05-31
Completion: 2024-05-31

Publications

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Niacin	Small molecule	200 mg	Oral
Subject	Piperine	Other / unclassified	15 mg	Oral
Subject	Pyridoxine	Unknown	50 mg	Oral
Subject	Thiamine	Other / unclassified	100 mg	Oral
Subject	alpha-lipoic acid	Small molecule	150 mg	Oral

Pilot Study of GLY-LOW Supplementation in Postmenopausal Women With Obesity

Summary

Timeline

Publications

Drugs

Indications