A Randomized, Double-blind, Placebo-controlled, Proof-of-concept Study to Evaluate the Safety and Efficacy of the Test Product KH-1 for Stimulating Autophagy in Non-diabetic Adults With Elevated Blood Glucose Concentration

Kalin Health, LLC1 site in 1 country42 target enrollmentDecember 20, 2021

ConditionsPreDiabetes Aging

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: PreDiabetes
Sponsor: Kalin Health, LLC
Enrollment: 42
Locations: 1
Primary Endpoint: Insulin Resistance
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Detailed Description

Prediabetes is the intermediate state and precursor that can lead to an eventual diagnosis of diabetes. The presence of an elevated hemoglobin A1c (HbA1c), as well as insulin resistance with concomitant β-cell dysfunction is a strong indicator of prediabetes. Dietary and lifestyle changes are the most effective methods to control and prevent prediabetes, but maintenance of these changes is often difficult. Pharmaceutical options are indicated for treatment of diabetes rather than prevention of prediabetes, however many are associated with side effects. Therefore, a safe and effective alternative to prevent disease in metabolically dysregulated individuals is necessary. The novel nutraceutical KH-1 is comprised of spermidine, amino acids, and a probiotic. This nutraceutical may offer a promising strategy for managing prediabetes. This study is a double-blinded randomized controlled trial with 48 healthy volunteers to test the efficacy and safety of the novel nutraceutical KH-1. A total of 48 participants will be randomized in a double-blinded fashion, with 24 participants in each study group (KH-1 vs. placebo). After screening and randomization, 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. Upon arrival at the clinic at the screening visit, participants will review the informed consent form (ICF), and if they agree to participate in the study, will sign and date the ICF, complete a brief screening, provide demographic information, and take part in other study activities indicated to be done on the screening visit. Participants who complete the screening process and qualify to continue are randomized to receive either the KH-1 or placebo in a 1:1 ratio for the first 3 months and assigned a unique randomization code. After the first 3 months, all participants will take KH-1. Participants will be instructed on the use of the nutraceutical product/placebo, according to label instructions. Participants will self-administer the study product at home and compliance will be assessed and documented at each visit. Venous blood samples will be collected at Week 0, Week 12 and Week 24 and analysed for biomarkers of glucose regulation and metabolism, cardiovascular health, inflammatory and autophagy biomarkers. Haematology and biochemistry parameters will be measured at screening, week 0, week 12 and week 24. A qualitative health questionnaire will be completed at 3 in-clinic visits and physical measurements to assess safety of the nutraceutical.

Registry

clinicaltrials.gov

Start Date

December 20, 2021

End Date

June 8, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Kalin Health, LLC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.
•Exclusion criteria:
•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.