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

NCT06445569 | Completed

• 1 other identifier: K02-21-01-T0012
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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

PreDiabetes; Aging

Keywords

Elevated Blood Glucose; Spermidine; Autophagy; Probiotic

Outcome Measures

Primary Outcomes (3)

• Insulin resistance

  Between placebo and test product, change from baseline to 3 months in fasting insulin

  3 months

• Insulin resistance

  Between placebo and test product, change from baseline to 3 months in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)

  3 months

• Insulin Resistance

  Between placebo and test product, change from baseline to 3 months Oral Glucose Tolerance Test (OGTT)- derived indices of insulin dynamics

  3 months

Secondary Outcomes (100)

• Long-term effect on Insulin Resistance

  3 months

• Long-term effect on Insulin Resistance

  6 months

• Long-term effect on Insulin Resistance

  3 months

• Long-term effect on Insulin Resistance

  6 months

• Long-term effect on Insulin resistance

  3 months

Study Arms (2)

KH-1

ACTIVE COMPARATOR

Three capsules containing spermidine and amino acids. One stick packet containing probiotics.

Dietary Supplement: KH-1

Placebo

PLACEBO COMPARATOR

Three capsules containing hypromellose, hypromellose acetate succinate, purified water, pigments and gellen gum. One stick packet containing microcrystalline cellulose.

Other: Placebo

Interventions

KH-1 DIETARY_SUPPLEMENT

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

KH-1

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adult participants who are at least 50 years of age (inclusive) at the time of signing the informed consent form.
• Have a body mass index (BMI) between 25.0 to 45.0 kg/m2 (inclusive).
• In good general health and good oral health (no active or uncontrolled diseases, infections or conditions).
• Impaired glucose metabolism evidence by either fasting glucose of 100 to 125 mg/dL at screening or an HbA1c between 5.7 and 6.4%.
• Female participants of childbearing potential (i.e., participants who are not surgically sterilized or not post-menopausal (defined as amenorrhea for greater than 1 year), or transgendered males with retained ovaries and uterus) must agree to use a medically approved method of birth control for at least one month prior (or three months prior in the case of oral or long-acting injective contraceptives) to the first dose of study product and throughout the study, or abstain from heterosexual intercourse throughout the duration of the study and have a negative urine pregnancy result at baseline. For males of reproductive potential: use of condoms, abstinence from heterosexual intercourse, or other methods to ensure that their partners (if able) do not become pregnant during the course of the study.
• Willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, and carry out all study-related procedures.

You may not qualify if:

• Participant has a medical history of uncontrolled hypertension (i.e., ≥160 mmHg systolic and/or ≥100 mmHg diastolic)
• Participant has a medical history of heart disease and/or cardiovascular disease, kidney disease (dialysis or renal failure), hepatic impairment or disease, or Type 1 or Type 2 diabetes.
• Participant has a medical history of unstable thyroid disease, previously diagnosed major affective disorder, psychiatric disorder that required hospitalization in the year prior to screening, immune disorder (i.e., HIV/AIDS), or a history of cancer (except localized skin cancer without metastases or in situ cervical cancer) within 5 years prior to screening visit.
• Female participants who are lactating, pregnant, or planning to become pregnant during the study.
• Have a known intolerance, sensitivity, or allergy to any of the study products or their ingredients, or any of the excipients used in the formulation.
• Have a known intolerance, sensitivity, or allergy to milk.
• Unable to be prescribed at least one of the antibiotics outlined in the study protocol.
• Any condition or abnormality that, in the opinion of the Investigator, would compromise the safety of the participant or the quality of the study data.
• Currently taking dietary supplements other than vitamins (a 14-day washout period prior to baseline/Visit 2 would be permitted).
• Taking any prescription medication at the time of randomization that is known to impact blood sugar and or blood sugar metabolism, as per Principal Investigator's (PI) discretion.
• Use of certain medications in timeframes defined in the study protocol (Ampicillin, Gentamicin, Kanamycin, Streptomycin, Erythromycin, Clindamycin, Tetracycline, Chloramphenicol, Potassium sparing diuretics, Nitroglycerin and other nitrates, antidiabetic/Blood sugar lowering medications, any blood thinning medications (i.e., anticoagulant/antiplatelet drugs), antidepressants (use is permitted if dosage is maintained throughout the study), anxiolytics, antipsychotics , anticholinergics/antispasmodics, calcium-channel blockers (use is permitted if dosage is maintained throughout the study), Opioids.
• Use of supplements dietary supplements/food/drink within 2 weeks or 7 half-lives (whichever is longer) prior to baseline and for the duration of the study, including foods/drinks rich in probiotics or prebiotics (e.g., yogurt, sauerkraut, kombucha) or synbiotics, Any herbs and supplements with hypoglycemic potential, any herbs or supplements that induce weight loss, any blood sugar lowering herbs or supplements, any blood thinning herbs or supplements
• History of alcohol or substance abuse in the 12 months prior to screening.
• Receipt or use of an investigational product in another research study within 28 days prior to baseline/Visit 2.

Sponsors & Collaborators

• Kalin Health, LLC: lead
• Nutrasource Pharmaceutical and Nutraceutical Services, Inc.: collaborator

Study Sites (1)

LifeDOC Research, PLLC

Memphis, Tennessee, 38119, United States

Location

MeSH Terms

Conditions

Prediabetic State; Hyperglycemia

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Pedro Velasquez, MD

  LifeDOC Research, PLLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will consume their assigned study product for 3 months, after which all participants will be assigned to consume the KH-1 for the remaining 3 months in an open-label fashion.

Study Record Dates

• First Submitted: May 31, 2024
• First Posted: June 6, 2024
• Study Start: December 20, 2021
• Primary Completion: June 8, 2023
• Study Completion: June 8, 2023
• Last Updated: June 6, 2024

Record last verified: 2024-05

Locations

US (1)