Overweight Clinical Trial
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.
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.
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 435mg/day. 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 mg/dL) 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. ;
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