Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06440213
Status:
RECRUITING
Last Update Posted:
2024-06-03
First Post:
2024-04-30
Brief Title:
A Study to Determine the Safety and Tolerability of a Range of Doses of PeptiControl in Pre-diabetic Individuals
Sponsor:
Nuritas Ltd
Organization:
Nuritas Ltd
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Parallel Clinical Study to Determine the Safety and Tolerability of a Range of Doses of PeptiControl in Pre-diabetic Individuals
Status:
RECRUITING
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:
A randomised double blind placebo controlled parallel study to examine the effects of a dose range of PeptiControl a plant-based ingredient in pre-diabetic males and females
Detailed Description:
The primary aim of this study is to evaluate safety and establish the effective dose to see acute effects in males and females with elevated fasting blood glucose PeptiControl will be supplemented 30 minutes before lunch as a single oral dose of either 2610mg 870mg or 435mgday A placebo group will also be included who will receive microcrystalline cellulose Capsule number will be matched across all study arms to retain double blinding
This trial incorporates continuous glucose monitoring CGM as wearable technology to measure blood glucose and time in range of the participants for the duration of the study The trial will be conducted over 12 days which includes a 2 day run-in period to gather baseline CGM data followed by 6 days of PeptiControl supplementation and 4 days follow up on safety and blood glucose tracking post supplementation
The primary endpoint will measure safety and tolerability via adverse event reporting and occurrence of hypoglycemic episodes evaluated by time below target range 70 - 180 mgdL during CGM throughout the intervention
Secondary endpoints investigated during the trial will include safety of a dose range as assessed by a safety blood panel glucose metabolism and insulin sensitivity time in range aspects of cognition and memory and hunger satiety and fullness as assessed by VAS questionnaires
This trial incorporates continuous glucose monitoring CGM as wearable technology to measure blood glucose and time in range of the participants for the duration of the study The trial will be conducted over 12 days which includes a 2 day run-in period to gather baseline CGM data followed by 6 days of PeptiControl supplementation and 4 days follow up on safety and blood glucose tracking post supplementation
The primary endpoint will measure safety and tolerability via adverse event reporting and occurrence of hypoglycemic episodes evaluated by time below target range 70 - 180 mgdL during CGM throughout the intervention
Secondary endpoints investigated during the trial will include safety of a dose range as assessed by a safety blood panel glucose metabolism and insulin sensitivity time in range aspects of cognition and memory and hunger satiety and fullness as assessed by VAS questionnaires
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