A Study to Determine the Safety and Tolerability of a Range of Doses of PeptiControl in Pre-diabetic Individuals

NCT06440213 | Completed DMC

• 1 other identifier: NRS/230703/PF/PDI
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 4

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.

Conditions

Pre Diabetes; Overweight

Outcome Measures

Primary Outcomes (1)

• 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)

  The hypoglycemic events will be monitored and recorded from the day of IP initiation (Day 0) until the end of study (Day 10). The tolerability of different doses of PeptiControl™ will be assessed on the basis of the hypoglycemic episodes evaluated by time below target range (70 - 180 mg/dL) during CGM throughout the study in each arm.

  Day 0 to Day 10

Secondary Outcomes (9)

• To explore the safety of a range of doses of PeptiControl™ as assessed by a safety blood panel comparing baseline and post dose parameters.

  Day 0 and Day 6

• 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

  Day 0

• To assess the efficacy of range of doses of PeptiControl™ on Glucose metabolism as assessed by incremental Area Under Curve (iAUC)

  Day 0

• To assess the efficacy of range of doses of PeptiControl™ on Pancreatic efficiency

  Day 0 and Day 6

• To assess the efficacy of range of doses of PeptiControl™ Time in range via CGM (Continuous Glucose Monitoring).

  Starting from day -2 and worn continuously until day 10 with readings taken at day -2, day 0, day 6, day 10

Study Arms (4)

PeptiControl™ (Low - Dose 435 mg/day)

ACTIVE COMPARATOR

6 capsules, 30 minutes prior to lunch every day for 6 days

Dietary Supplement: PeptiControl™ (Low - Dose 435 mg/day)

PeptiControl™ (Mid - Dose 870 mg/day)

ACTIVE COMPARATOR

6 capsules, 30 minutes prior to lunch every day for 6 days

Dietary Supplement: PeptiControl™ (Mid - Dose 870 mg/day)

PeptiControl™ (High - Dose 2610 mg/day)

ACTIVE COMPARATOR

6 capsules, 30 minutes prior to lunch every day for 6 days

Dietary Supplement: PeptiControl™ (High - Dose 2610 mg/day)

Placebo Microcrystalline Cellulose

PLACEBO COMPARATOR

6 capsules, 30 minutes prior to lunch every day for 6 days

Dietary Supplement: Placebo Microcrystalline Cellulose

Interventions

PeptiControl™ (Low - Dose 435 mg/day) DIETARY_SUPPLEMENT

Plant protein hydrolysate

PeptiControl™ (Low - Dose 435 mg/day)

PeptiControl™ (Mid - Dose 870 mg/day) DIETARY_SUPPLEMENT

Plant protein hydrolysate

PeptiControl™ (Mid - Dose 870 mg/day)

PeptiControl™ (High - Dose 2610 mg/day) DIETARY_SUPPLEMENT

Plant protein hydrolysate

PeptiControl™ (High - Dose 2610 mg/day)

Placebo Microcrystalline Cellulose DIETARY_SUPPLEMENT

Placebo MCC micro-crystalline cellulose

Placebo Microcrystalline Cellulose

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nuritas Ltd: lead

Study Sites (4)

Chopda Medicare & Research Centre

Nashik, Maharashtra, 422005, India

Location

Vakretund Hospital

Nashik, Maharashtra, 422010, India

Location

Ashwin Medical Foundation

Pune, Maharashtra, 411033, India

Location

Imperial Multispeciality Hospital

Pune, Maharashtra, 411062, India

Location

MeSH Terms

Conditions

Glucose Intolerance; Overweight

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dr. Ravindra Kulkarni, MBBS,DNB,MD

  Ashwin Medical Foundation Pune, Maharashtra, India, 411033

  PRINCIPAL INVESTIGATOR

• Dr. Vishwajeet Gaikwad, MBBS, MD

  Imperial Multispecialty Hospital Pune, Maharashtra, India, 411062

  PRINCIPAL INVESTIGATOR

• Dr. Nilesh Tuplondhe, MBBS, MD

  Chopda Medicare & Research centre Nashik, Maharashtra, India, 422005

  PRINCIPAL INVESTIGATOR

• Dr. Sagar Mandlik, MBBS, MD

  Vakratund Hospital Pvt. Ltd Nashik, Maharashtra, India, 422010

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled, parallel group study

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: June 3, 2024
• Study Start: May 20, 2024
• Primary Completion: December 22, 2024
• Study Completion: February 1, 2025
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IN (4)