PreDiabetesNCT06445569
Safety and Efficacy of KH-1 for Stimulating Autophagy in Non-diabetic Adults With Elevated Blood Glucose Concentration
A study testing KH-1 in people with PreDiabetes and Aging, run by Kalin Health, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- PreDiabetes, Aging
- What is being tested?
- KH-1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2021to 8 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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.
- Conditions
- PreDiabetes, Aging
- Being tested
- KH-1, Placebo
- Keywords
- Elevated Blood Glucose, Spermidine, Autophagy, Probiotic
- Medical subject headings
- Prediabetic State, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KH-1Dietary supplement
3 capsules and one stick packet consumed daily around the same time
PlaceboOther
3 capsules and one stick packet consumed daily around the same time
| Study group | Role | What they receive |
|---|---|---|
| KH-1 | Active comparator | Three capsules containing spermidine and amino acids. One stick packet containing probiotics. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin resistance
Between placebo and test product, change from baseline to 3 months in fasting insulin
Measured: 3 months
Insulin resistance
Between placebo and test product, change from baseline to 3 months in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Measured: 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
Measured: 3 months
Secondary outcomes (100)
Long-term effect on Insulin Resistance
Within-group change from baseline to 3 months for fasting insulin
Measured: 3 months
Long-term effect on Insulin Resistance
Within-group change from baseline to 6 months for fasting insulin
Measured: 6 months
Long-term effect on Insulin Resistance
Within-group change from baseline to 3 months for HOMA-IR
Measured: 3 months
Long-term effect on Insulin Resistance
Within-group change from baseline to 6 months for HOMA-IR
Measured: 6 months
Long-term effect on Insulin resistance
Within-group change from baseline to 3 months for OGTT-derived indices
Measured: 3 months
Long-term effect on Insulin Resistance
Within-group change from baseline to 6 months for OGTT-derived indices
Measured: 6 months
Post-prandial Glycemic Response
Between placebo and test product, change from baseline to 3 months in area under the glucose concentration (AUC) post-OGTT
Measured: 3 months
Post-prandial Glycemic Response
Within-group change from baseline to 3 months in area under the glucose concentration (AUC) post-OGTT
Measured: 3 months
Post-prandial Glycemic Response
Within-group change from baseline to 6 months in area under the glucose concentration (AUC) post-OGTT
Measured: 6 months
Post-prandial Glycemic Response
Between placebo and test product, change from baseline to 3 months in 2-hour post-prandial glucose
Measured: 3 months
Post-prandial Glycemic Response
Within-group change from baseline to 3 months in 2-hour post-prandial glucose
Measured: 3 months
Post-prandial Glycemic Response
Within-group change from baseline to 6 months in 2-hour post-prandial glucose
Measured: 6 months
Glycemic Control
Between placebo and test product, change from baseline to 3 months in fasting glucose
Measured: 3 months
Glycemic Control
Within-group change from baseline to 3 months in fasting glucose
Measured: 3 months
Glycemic Control
Within-group change from baseline to 6 months in fasting glucose
Measured: 6 months
Glycemic Control
Between placebo and test product, change from baseline to 3 months in HbA1c
Measured: 3 months
Glycemic Control
Within-group change from baseline to 3 months in HbA1c
Measured: 3 months
Glycemic Control
Within-group change from baseline to 6 months in HbA1c
Measured: 6 months
β-cell Function
Between placebo and test product, change from baseline to 3 months in oral disposition index (DI) calculated by the ratio of the insulinogenic index over fasting insulin
Measured: 3 months
β-cell Function
Within-group change from baseline to 3 months in oral DI
Measured: 3 months
β-cell Function
Within-group change from baseline to 6 months in oral DI
Measured: 6 months
Cardiovascular Biomarkers
Between placebo and test product, change from baseline to 3 months in fasting triglycerides (TG)
Measured: 3 months
Cardiovascular Biomarkers
Within-group change from baseline to 3 months in fasting TG
Measured: 3 months
Cardiovascular Biomarkers
Within-group change from baseline to 6 months in fasting TG
Measured: 6 months
Cardiovascular Biomarkers
Between placebo and test product, change from baseline to 3 months in fasting total cholesterol
Measured: 3 months
Cardiovascular Biomarkers
Within-group change from baseline to 3 months in fasting total cholesterol
Measured: 3 months
Cardiovascular Biomarkers
Within-group change from baseline to 6 months in fasting total cholesterol
Measured: 6 months
Cardiovascular Biomarkers
Between placebo and test product, change from baseline to 3 months in fasting low-density lipoprotein (LDL)
Measured: 3 months
Cardiovascular Biomarkers
Within-group change from baseline to 3 months in fasting LDL
Measured: 3 months
Cardiovascular Biomarkers
Within-group change from baseline to 6 months in fasting LDL
Measured: 6 months
Cardiovascular Biomarkers
Between placebo and test product, change from baseline to 3 months in high-density lipoprotein (HDL)
Measured: 3 months
Cardiovascular Biomarkers
Within-group change from baseline to 3 months in HDL
Measured: 3 months
Cardiovascular Biomarkers
Within-group change from baseline to 6 months in HDL
Measured: 6 months
Inflammatory Biomarkers
Between placebo and test product, change from baseline to 3 months in high-sensitivity C-reactive protein (hs-CRP)
Measured: 3 months
Inflammatory Biomarkers
Within-group change from baseline to 3 months in hs-CRP
Measured: 3 months
Inflammatory Biomarkers
Within-group change from baseline to 6 months in hs-CRP
Measured: 6 months
Inflammatory Biomarkers
Between placebo and test product, change from baseline to 3 months in tumor necrosis factor (TNF)-alpha
Measured: 3 months
Inflammatory Biomarkers
Within-group change from baseline to 3 months in TNF-alpha
Measured: 3 months
Inflammatory Biomarkers
Within-group change from baseline to 6 months in TNF-alpha
Measured: 6 months
Inflammatory Biomarkers
Between placebo and test product, change from baseline to 3 months in interleukin-6 (IL-6)
Measured: 3 months
Inflammatory Biomarkers
Within-group change from baseline to 3 months in IL-6
Measured: 3 months
Inflammatory Biomarkers
Within-group change from baseline to 6 months in IL-6
Measured: 6 months
Autophagy
Between placebo and test product, change from baseline to 3 months in Beclin-1
Measured: 3 months
Autophagy
Within-group change from baseline to 3 months in Beclin-1
Measured: 3 months
Autophagy
Within-group change from baseline to 6 months in Beclin-1
Measured: 6 months
Immunity Biomarkers
Between placebo and test product, change from baseline to 3 months in Cluster of Differentiation (CD) 3
Measured: 3 months
Immunity Biomarkers
Within-group change from baseline to 3 months in CD3
Measured: 3 months
Immunity Biomarkers
Within-group change from baseline to 6 months in CD3
Measured: 6 months
Immunity Biomarkers
Between placebo and test product, change from baseline to 3 months in CD4
Measured: 3 months
Immunity Biomarkers
Within-group change from baseline to 3 months in CD4
Measured: 3 months
Immunity Biomarkers
Within-group change from baseline to 6 months in CD4
Measured: 6 months
Immunity Biomarkers
Between placebo and test product, change from baseline to 3 months in CD8
Measured: 3 months
Immunity Biomarkers
Within-group change from baseline to 3 months in CD8
Measured: 3 months
Immunity Biomarkers
Within-group change from baseline to 6 months in CD8
Measured: 6 months
Immunity Biomarkers
Between placebo and test product, change from baseline to 3 months in CD25
Measured: 3 months
Immunity Biomarkers
Within-group change from baseline to 3 months in CD25
Measured: 3 months
Immunity Biomarkers
Within-group change from baseline to 6 months in CD25
Measured: 6 months
Overall Patient Health
Between placebo and test product, change from baseline to 3 months in Patient Health Questionnaire scores
Measured: 3 months
Overall Patient Health
Within-group change from baseline to 3 months in Patient Health Questionnaire scores
Measured: 3 months
Overall Patient Health
Within-group change from baseline to 6 months in Patient Health Questionnaire scores
Measured: 6 months
Overall Quality of Life
Between placebo and test product, change from baseline to 3 months in RAND-36 questionnaire scores
Measured: 3 months
Overall Quality of Life
Within-group change from baseline to 3 months in RAND-36 questionnaire scores
Measured: 3 months
Overall Quality of Life
Within-group change from baseline to 6 months in RAND-36 questionnaire scores
Measured: 6 months
Stress
Between placebo and test product, change from baseline to 3 months in Perceived Stress Scale (PSS) scores
Measured: 3 months
Stress
Within-group change from baseline to 3 months in PSS scores
Measured: 3 months
Stress
Within-group change from baseline to 6 months in PSS scores
Measured: 6 months
Systolic Blood Pressure (SBP)
Change from baseline to 6 months in SBP (mmHg)
Measured: 6 months
Diastolic Blood Pressure (DBP)
Change from baseline to 6 months in DBP (mmHg)
Measured: 6 months
Heart Rate
Change from baseline to 6 months in heart rate (beats per minute)
Measured: 6 months
Weight
Change from baseline to 6 months in weight (kg)
Measured: 6 months
Percent Body Fat
Change from baseline to 6 months in percent body fat (%)
Measured: 6 months
Body Mass Index (BMI)
Change from baseline to 6 months in BMI (kg/m2)
Measured: 6 months
Whole Blood Hemoglobin
Change from baseline in fasting whole blood hemoglobin (g/dL)
Measured: 6 months
Whole Blood Hematocrit
Change from baseline in fasting whole blood hematocrit (%)
Measured: 6 months
Whole Blood Red Blood Cell Count
Change from baseline in fasting whole blood red blood cell count (x10^6/uL)
Measured: 6 months
Whole Blood Red Blood Cell Distribution Width
Change from baseline in fasting whole blood red blood cell distribution width (%)
Measured: 6 months
Whole Blood Mean Corpuscular Volume
Change from baseline in fasting whole blood mean corpuscular volume (fL)
Measured: 6 months
Whole Blood Mean Corpuscular Hemoglobin
Change from baseline in fasting whole blood mean corpuscular hemoglobin (pg)
Measured: 6 months
Whole Blood Mean Corpuscular Hemoglobin Concentration
Change from baseline in fasting whole blood mean corpuscular hemoglobin concentration (g/dL)
Measured: 6 months
Whole Blood White Blood Cells
Change from baseline in fasting whole blood white blood cells (x10^3/uL)
Measured: 6 months
Whole Blood Neutrophils
Change from baseline in fasting whole blood neutrophils (cells/uL)
Measured: 6 months
Whole Blood Basophils
Change from baseline in fasting whole blood basophils (cells/uL)
Measured: 6 months
Whole Blood Eosinophils
Change from baseline in fasting whole blood eosinophils (cells/uL)
Measured: 6 months
Whole Blood Lymphocytes
Change from baseline in fasting whole blood lymphocytes (cells/uL)
Measured: 6 months
Whole Blood Monocytes
Change from baseline in fasting whole blood monocytes (cells/uL)
Measured: 6 months
Whole Blood Mean Platelet Volume
Change from baseline in fasting whole blood mean platelet volume (fL)
Measured: 6 months
Whole Blood Platelet Count
Change from baseline in fasting whole blood platelet count (x10^9/L)
Measured: 6 months
Serum Creatinine
Change from baseline in fasting serum creatinine (umol/L)
Measured: 6 months
Serum Blood Urea Nitrogen
Change from baseline in fasting serum blood urea nitrogen (mg/dL)
Measured: 6 months
Serum Alkaline Phosphatase (ALP)
Change from baseline in fasting serum ALP (U/L)
Measured: 6 months
Serum Asparatate Transaminase (AST)
Change from baseline in fasting serum AST (U/L)
Measured: 6 months
Serum Alanine Transaminase (ALT)
Change from baseline in fasting serum ALT (U/L)
Measured: 6 months
Serum Albumin
Change from baseline in fasting serum albumin (g/dL)
Measured: 6 months
Serum Total Protein
Change from baseline in fasting serum total protein (g/dL)
Measured: 6 months
Serum Chloride
Change from baseline in fasting serum chloride (mmol/L)
Measured: 6 months
Serum Sodium
Change from baseline in fasting serum sodium (mmol/L)
Measured: 6 months
Serum Potassium
Change from baseline in fasting serum potassium (mmol/L)
Measured: 6 months
Serum Calcium
Change from baseline in fasting serum calcium (mg/dL)
Measured: 6 months
Serum Urea
Change from baseline in fasting serum urea (mg/dL)
Measured: 6 months
Incidence of Adverse Events
Number of participants with adverse events
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start20 Dec 2021
- Primary completion8 Jun 2023
- Study completion8 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kalin Health, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Responsible party
- Sponsor
- Investigators
- Pedro Velasquez, MD, Principal investigator, LifeDOC Research, PLLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06445569
- Sponsor's protocol ID
- K02-21-01-T0012
- Status last verified
- May 2024
- First submitted
- 31 May 2024
- Last updated
- 6 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06445569
- Acronym / sponsor ID
- K02-21-01-T0012
- Conditions
- PreDiabetes, Aging
- Keywords
- Elevated Blood Glucose, Spermidine, Autophagy, Probiotic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Kalin Health, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Study start
- 20 Dec 2021 (actual)
- Primary completion
- 8 Jun 2023 (actual)
- Study completion
- 8 Jun 2023 (actual)
- First posted
- 6 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| KH-1 | Active comparator | Dietary Supplement: KH-1Three capsules containing spermidine and amino acids. One stick packet containing probiotics. |
| Placebo | Placebo comparator | Other: PlaceboThree capsules containing hypromellose, hypromellose acetate succinate, purified water, pigments and gellen gum. One stick packet containing microcrystalline cellulose. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KH-13 capsules and one stick packet consumed daily around the same time | Dietary supplement | KH-1 |
| Placebo3 capsules and one stick packet consumed daily around the same time | Other | Placebo |
Primary outcome
Insulin resistance
Time frame: 3 months
Between placebo and test product, change from baseline to 3 months in fasting insulin
Insulin resistance
Time frame: 3 months
Between placebo and test product, change from baseline to 3 months in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Insulin Resistance
Time frame: 3 months
Between placebo and test product, change from baseline to 3 months Oral Glucose Tolerance Test (OGTT)- derived indices of insulin dynamics
100 secondary outcomes
Long-term effect on Insulin Resistance
Time frame: 3 months
Long-term effect on Insulin Resistance
Time frame: 6 months
Long-term effect on Insulin Resistance
Time frame: 3 months
Long-term effect on Insulin Resistance
Time frame: 6 months
Long-term effect on Insulin resistance
Time frame: 3 months
Long-term effect on Insulin Resistance
Time frame: 6 months
Post-prandial Glycemic Response
Time frame: 3 months
Post-prandial Glycemic Response
Time frame: 3 months
Post-prandial Glycemic Response
Time frame: 6 months
Post-prandial Glycemic Response
Time frame: 3 months
Post-prandial Glycemic Response
Time frame: 3 months
Post-prandial Glycemic Response
Time frame: 6 months
Glycemic Control
Time frame: 3 months
Glycemic Control
Time frame: 3 months
Glycemic Control
Time frame: 6 months
Glycemic Control
Time frame: 3 months
Glycemic Control
Time frame: 3 months
Glycemic Control
Time frame: 6 months
β-cell Function
Time frame: 3 months
β-cell Function
Time frame: 3 months
β-cell Function
Time frame: 6 months
Cardiovascular Biomarkers
Time frame: 3 months
Cardiovascular Biomarkers
Time frame: 3 months
Cardiovascular Biomarkers
Time frame: 6 months
Cardiovascular Biomarkers
Time frame: 3 months
Cardiovascular Biomarkers
Time frame: 3 months
Cardiovascular Biomarkers
Time frame: 6 months
Cardiovascular Biomarkers
Time frame: 3 months
Cardiovascular Biomarkers
Time frame: 3 months
Cardiovascular Biomarkers
Time frame: 6 months
Cardiovascular Biomarkers
Time frame: 3 months
Cardiovascular Biomarkers
Time frame: 3 months
Cardiovascular Biomarkers
Time frame: 6 months
Inflammatory Biomarkers
Time frame: 3 months
Inflammatory Biomarkers
Time frame: 3 months
Inflammatory Biomarkers
Time frame: 6 months
Inflammatory Biomarkers
Time frame: 3 months
Inflammatory Biomarkers
Time frame: 3 months
Inflammatory Biomarkers
Time frame: 6 months
Inflammatory Biomarkers
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pedro Velasquez, MD principal investigator
LifeDOC Research, PLLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KH-1 in people with PreDiabetes and Aging, run by Kalin Health, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin resistance (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2024.