Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06445569
Status:
COMPLETED
Last Update Posted:
2024-06-06
First Post:
2024-05-31
Brief Title:
Safety and Efficacy of KH-1 for Stimulating Autophagy in Non-diabetic Adults With Elevated Blood Glucose Concentration
Sponsor:
Kalin Health LLC
Organization:
Kalin Health LLC
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Aging significantly impacts overall health and is a risk factor for developing diabetes An estimated 50 of US adults aged 65 years were reported to have prediabetes defined as having a fasting glucose concentration of 100-125 mgdl 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 11 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 productplacebo 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
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 11 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 productplacebo 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None