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

NCT06440213 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2025-03-13

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

PeptiControl™ (Low - Dose 435 mg/day)

Plant protein hydrolysate

DIETARY_SUPPLEMENT

PeptiControl™ (Mid - Dose 870 mg/day)

Plant protein hydrolysate

DIETARY_SUPPLEMENT

PeptiControl™ (High - Dose 2610 mg/day)

Plant protein hydrolysate

DIETARY_SUPPLEMENT

Placebo Microcrystalline Cellulose

Placebo MCC micro-crystalline cellulose

Sponsors & Collaborators

  • Nuritas Ltd

    lead INDUSTRY

Principal Investigators

  • Dr. Ravindra Kulkarni, MBBS,DNB,MD · Ashwin Medical Foundation Pune, Maharashtra, India, 411033

  • Dr. Vishwajeet Gaikwad, MBBS, MD · Imperial Multispecialty Hospital Pune, Maharashtra, India, 411062

  • Dr. Nilesh Tuplondhe, MBBS, MD · Chopda Medicare & Research centre Nashik, Maharashtra, India, 422005

  • Dr. Sagar Mandlik, MBBS, MD · Vakratund Hospital Pvt. Ltd Nashik, Maharashtra, India, 422010

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-20
Primary Completion
2024-12-22
Completion
2025-02-01

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06440213 on ClinicalTrials.gov