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

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).

Conditions

• Insulin Resistance
• Obesity
• Cardiovascular Diseases
• Cognitive Impairment
• Physical Disability
• Depression
• Inflammation
• Hormone Deficiency
• Physical Inactivity
• Hyperlipidemias
• Hypertension
• Overeating

Interventions

BIOLOGICAL

GLY-LOW

This supplement is available for over-the-counter purchase. Each capsule is a combination of vitamins and natural products: Vitamin B1 (100mg); Vitamin B6 (50mg); Niacin (200mg); Alpha Lipoic Acid (150mg); and Piperine (15mg). The supplement, GLY-LOW, is FDA approved for use as a dietary supplement (IND 162006)

Sponsors & Collaborators

• Buck Institute for Research on Aging

  collaborator OTHER

• University of Wyoming

  collaborator OTHER

• Hoskinson Health and Wellness Clinic

  lead INDUSTRY

Principal Investigators

• Sanjay Dhar, PhD · Hoskinson Health and Wellness Clinic

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

56 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-07-27

Primary Completion

2024-05-31

Completion

2024-05-31

FDA Drug

Yes

Countries

• United States

Study Locations