Clinical trial NCT06440213: A Study to Determine the Safety and Tolerability of a Range of Doses of PeptiControl in Pre-diabetic Individuals
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre Diabetes
Overweight
Lead sponsor: Nuritas Ltd
Sponsor class: INDUSTRY
First posted: 2024-06-03
Enrollment: 132
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind, placebo-controlled, parallel group study
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

* Males and Females (30-60 years of age)
* Individuals with Body Mass Index (BMI) more than or equal to 25 and less than or equal to 33.0 kg/m²
* Individuals with fasting blood glucose (FBG) more than or equal to 100 mg/dL and less than or equal to 125 mg/dL after 8-10 hours fasting.
* Individual must be a non-smoker or an ex-smoker (5 years or more).
* Have a stable body weight (less than or equal to 4.5 kgs change) in the last 3 months (as self-reported by the individual).
* Be willing to maintain existing dietary habits and physical activity levels throughout the study period.
* Individual must be willing to wear a continuous glucose monitor during the specific time in the study
* Individual must be willing to attend all site visits and follow protocols for that visit, e.g., arrive fasting and provide blood samples.
* Individuals who have given their signed Informed Consent.

Exclusion Criteria:

* Individuals having fasting blood glucose levels less than 100 mg/dL or more than 125 mg/dL.
* Individuals having BMI outside the range of 25 - 33 kg/m².
* Individuals who are presently dieting, or who were using medications affecting body weight or who had experienced a change in weight of more than 4.5 kg or a change in physical activity within the six months preceding the screening visit.
* Individuals diagnosed with Type I Diabetes mellitus.
* Individuals diagnosed with Type II Diabetes mellitus and currently on medication.
* Individuals with Triglyceride levels more than 200 mg/dL, and/or liver function tests (AST, ALT) levels 1.5 times than the normal range, and/or kidney function test (serum creatinine) levels 1.5 times than the normal range.
* Individuals with low haemoglobin or haematocrit (i.e., lower than normal ranges \[less than 12.0 g/dL hemoglobin levels in women and less than 13.0 g/dL hemoglobin levels in men\])
* Individuals having a significant acute or chronic co-existing illnesssuch as cardiovascular disease, chronic kidney or liver disease, gastrointestinal disorder, endocrine disorder, immunological disorder, metabolic disease, or any condition which contraindicates, in the investigator's judgement, entry to the study or which poses a significant risk to the individual.
* Individuals diagnosed with hypertension (systolic blood pressure more than 140 mm Hg and/or diastolic blood pressure more than 90 mm Hg) and currently on medication.
* Individuals who have unstable medical conditions or who are on chronic medication that has not been at a stable dose for at least 1 month.
* Consumption of more than the recommended alcohol guidelines i.e., more than 21 alcohol units/week for males and more than 14 alcohol units/week for females.
* Currently or recently (within 3 months of study entry) taking any medication, which in the opinion of the investigator, could interfere with the outcome of the study, including insulin, acetylsalicylic acid, thyroxine, beta blockers, or hypolipidemic agents.
* Individuals on any medications associated with weight loss such as medication for the treatment of deficit hyperactivity, medication associated with weight gain like antipsychotics, or glucocorticoids, and/or immunosuppressants.
* Have a known allergy or sensitivity to any compounds in the test material's active or inactive ingredients or placebo.
* Individuals having a history of drug or alcohol abuse.
* Individuals who have a history of neurological disorders or significant psychiatric illness, who are cognitively impaired and/or who are unable to give informed consent.
* Present or recent use (within 3 months of pre-screening) of dietary supplements that may affect the level of blood glucose, e.g., chromium, dietary fibres, and non-digestible carbohydrates e.g., fructooligosaccharides chicory inulin, mulberry leaf extract.
* Females who are pregnant, lactating or wish to become pregnant during the study.
* Individuals with evidence of a clinically unstable disease (such as depression), as determined by medical history, physical examination, that, in the Investigator and medical monitors opinion, preclude entry into the study.
* Breast feeding women.
* Immune compromised individuals.
* Individuals who have participated in a clinical study with an investigational product (IP) within 90 days before pre-screening, or who plan to participate in another study during the study period.

Primary outcomes:
measure: To investigate the safety and tolerability of a range of doses of PeptiControl™ as assessed by occurrence of hypoglycemic episodes evaluated by time below target range (70 - 180 mg/dL) during Continuous Glucose Monitoring (CGM)
timeFrame: Day 0 to Day 10
Secondary outcomes:
measure: To explore the safety of a range of doses of PeptiControl™ as assessed by a safety blood panel comparing baseline and post dose parameters.
timeFrame: Day 0 and Day 6
measure: To assess the efficacy of range of doses of PeptiControl™ on blood glucose concentrations when given 30 minutes prior to Oral Glucose Tolerance Test (OGTT) compared to placebo
timeFrame: Day 0
measure: To assess the efficacy of range of doses of PeptiControl™ on Glucose metabolism as assessed by incremental Area Under Curve (iAUC)
timeFrame: Day 0
measure: To assess the efficacy of range of doses of PeptiControl™ on Pancreatic efficiency
timeFrame: Day 0 and Day 6
measure: To assess the efficacy of range of doses of PeptiControl™ Time in range via CGM (Continuous Glucose Monitoring).
timeFrame: Starting from day -2 and worn continuously until day 10 with readings taken at day -2, day 0, day 6, day 10
measure: To assess the efficacy of range of doses of PeptiControl™ on Insulin sensitivity as assessed by Homeostatic Model Assessment for Insulin Resistance (HOMA-IR).
timeFrame: Day 0 and Day 6
measure: To assess the efficacy of range of doses of PeptiControl™ on Working memory as assessed by Paired Associate Learning test
timeFrame: Day 0, Day 6, and Day 10
measure: To assess the efficacy of range of doses of PeptiControl™ on Selective attention as assessed by Stroop test.
timeFrame: Day 0, Day 6, and Day 10
measure: To assess the efficacy of range of doses of PeptiControl™ on Hunger, satiety and fullness as assessed by the Visual Analog Scale (VAS)
timeFrame: Day 0, Day 6, and Day 10
Other outcomes:
Locations:
city: Nashik
country: India
facility: Chopda Medicare & Research Centre
state: Maharashtra
city: Nashik
country: India
facility: Vakretund Hospital
state: Maharashtra
city: Pune
country: India
facility: Ashwin Medical Foundation
state: Maharashtra
city: Pune
country: India
facility: Imperial Multispeciality Hospital
state: Maharashtra
Study officials:
affiliation: Ashwin Medical Foundation Pune, Maharashtra, India, 411033
name: Dr. Ravindra Kulkarni, MBBS,DNB,MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Imperial Multispecialty Hospital Pune, Maharashtra, India, 411062
name: Dr. Vishwajeet Gaikwad, MBBS, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chopda Medicare & Research centre Nashik, Maharashtra, India, 422005
name: Dr. Nilesh Tuplondhe, MBBS, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vakratund Hospital Pvt. Ltd Nashik, Maharashtra, India, 422010
name: Dr. Sagar Mandlik, MBBS, MD
role: PRINCIPAL_INVESTIGATOR
References: