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Safety and Efficacy of KH-1 for Stimulating Autophagy in Non-diabetic Adults With Elevated Blood Glucose Concentration

NCT06445569 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2024-06-06

No results posted yet for this study

Summary

Aging significantly impacts overall health and is a risk factor for developing diabetes. An estimated 50% of U.S. adults aged ≥65 years were reported to have prediabetes (defined as having a fasting glucose concentration of 100-125 mg/dl) in 2005-2008. The Centers for Disease Control and Prevention (CDC) has stated that in the United States, 88 million people (one in every 3 Americans) are currently classified as prediabetic, emphasizing the importance of preventative measures and early intervention to manage and reduce the risk of progression to diabetes. Additionally, an estimated 430 million individuals worldwide are expected to have prediabetes by 2030. Dietary supplementation of polyamines, spermidine in particular, have been touted to have beneficial health effects such as increasing life span and mitigating impacts of aging. Spermidine and spermine are polyamines that are being increasingly investigated for their ability to slow the aging process by inducing autophagy. Nevertheless, literature on these topics is scarce and results from trials have been inconclusive; therefore further research is needed. The novel nutraceutical KH-1, comprised of spermidine, spermidine derivatives and probiotics, is examined in this trial of healthy volunteers aged 18 years or over. This study evaluates KH-1 for its safety and its effect on glucose homeostasis. This study measures the effects of KH-1 on biomarkers for inflammation, cardiovascular disease, insulin sensitivity, and those important for autophagy. A qualitative assessment of the effect of KH-1 on well-being is also examined.

Conditions

Interventions

DIETARY_SUPPLEMENT

KH-1

3 capsules and one stick packet consumed daily around the same time

OTHER

Placebo

3 capsules and one stick packet consumed daily around the same time

Sponsors & Collaborators

  • Nutrasource Pharmaceutical and Nutraceutical Services, Inc.

    collaborator NETWORK

  • Kalin Health, LLC

    lead INDUSTRY

Principal Investigators

  • Pedro Velasquez, MD · LifeDOC Research, PLLC

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-20
Primary Completion
2023-06-08
Completion
2023-06-08

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06445569 on ClinicalTrials.gov