Pre DiabetesNCT06440213
A Study to Determine the Safety and Tolerability of a Range of Doses of PeptiControl in Pre-diabetic Individuals
A study of Pre Diabetes and Overweight, run by Nuritas Ltd at 4 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pre Diabetes, Overweight
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 4 sitesIndia
- Study dates
- 20 May 2024to 1 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
4 sites in 1 country.
India4 sites
Chopda Medicare & Research Centre
Nashik, Maharashtra, 422005
Vakretund Hospital
Nashik, Maharashtra, 422010
Ashwin Medical Foundation
Pune, Maharashtra, 411033
Imperial Multispeciality Hospital
Pune, Maharashtra, 411062
About this study
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.
Read the 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.
- Conditions
- Pre Diabetes, Overweight
- Being tested
- PeptiControl™ (Low - Dose 435 mg/day), PeptiControl™ (Mid - Dose 870 mg/day), PeptiControl™ (High - Dose 2610 mg/day), Placebo Microcrystalline Cellulose
- Medical subject headings
- Glucose Intolerance, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PeptiControl™ (Low - Dose 435 mg/day)Dietary supplement
Plant protein hydrolysate
PeptiControl™ (Mid - Dose 870 mg/day)Dietary supplement
Plant protein hydrolysate
PeptiControl™ (High - Dose 2610 mg/day)Dietary supplement
Plant protein hydrolysate
Placebo Microcrystalline CelluloseDietary supplement
Placebo MCC micro-crystalline cellulose
| Study group | Role | What they receive |
|---|---|---|
| PeptiControl™ (Low - Dose 435 mg/day) | Active comparator | 6 capsules, 30 minutes prior to lunch every day for 6 days Receives: 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 Receives: 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 Receives: 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 Receives: Dietary Supplement: Placebo Microcrystalline Cellulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Blood samples will be taken from participants pre and post consumption of PeptiControl and analysed in a safety blood panel assessing liver, kidney and lipid markers for the identification of any changes from baseline.
Measured: 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
Thirty minutes post IP consumption, participants will consume a glucose solution (comprising of 75g glucose in approximately 250 ml water). Blood samples will then be collected at 15, 30, 60, 90, 120 and 180 mins for the assessment of blood glucose concentrations
Measured: Day 0
To assess the efficacy of range of doses of PeptiControl™ on Glucose metabolism as assessed by incremental Area Under Curve (iAUC)
The glucose iAUC will be derived from the OGTT. This assessment will be conducted at 0, 15, 30, 60, 90, 120 and 180 mins after glucose solution consumption
Measured: Day 0
To assess the efficacy of range of doses of PeptiControl™ on Pancreatic efficiency
Pancreatic efficiency will be evaluated by fasting serum insulin levels in blood Fasting insulin: Normal range - 2.6-24.9 μU/mL (17.8-173 pmol/L)
Measured: Day 0 and Day 6
To assess the efficacy of range of doses of PeptiControl™ Time in range via CGM (Continuous Glucose Monitoring).
Continuous glucose monitoring device automatically calculates the time in the blood glucose target range (70 - 180 mg/dl) as well as above and below the target range
Measured: Starting from day -2 and worn continuously until day 10 with readings taken at day -2, day 0, day 6, day 10
To assess the efficacy of range of doses of PeptiControl™ on Insulin sensitivity as assessed by Homeostatic Model Assessment for Insulin Resistance (HOMA-IR).
Insulin sensitivity will be assessed by HOMA-IR.
The HOMA - IR score will be calculated using the formula:
fasting insulin (mU/L) x fasting glucose (mmol/L)/22.5.
Fasting insulin: Normal range - 2.6-24.9 μU/mL (17.8-173 pmol/L) Fasting Glucose: Normal range - 4.11-6.05 mmol/L(74-109 mg/dL)
Measured: Day 0 and Day 6
To assess the efficacy of range of doses of PeptiControl™ on Working memory as assessed by Paired Associate Learning test
Working memory will be assessed using the Validated Paired Associate Learning test by Creyos.
Measured: Day 0, Day 6, and Day 10
To assess the efficacy of range of doses of PeptiControl™ on Selective attention as assessed by Stroop test.
Selective attention will be assessed using the Double Trouble/Stroop test by Creyos
Measured: Day 0, Day 6, and Day 10
To assess the efficacy of range of doses of PeptiControl™ on Hunger, satiety and fullness as assessed by the Visual Analog Scale (VAS)
The VAS will be 100 mm in length with words anchored at each end expressing the most positive and the most negative rating. It will assess five components: hunger, satiety, fullness, prospective food consumption and desire to eat.
Measured: Day 0, Day 6, and Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start20 May 2024
- Primary completion22 Dec 2024
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo-controlled, parallel group study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nuritas Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Ravindra Kulkarni, MBBS,DNB,MD, Principal investigator, Ashwin Medical Foundation Pune, Maharashtra, India, 411033Dr. Vishwajeet Gaikwad, MBBS, MD, Principal investigator, Imperial Multispecialty Hospital Pune, Maharashtra, India, 411062Dr. Nilesh Tuplondhe, MBBS, MD, Principal investigator, Chopda Medicare & Research centre Nashik, Maharashtra, India, 422005Dr. Sagar Mandlik, MBBS, MD, Principal investigator, Vakratund Hospital Pvt. Ltd Nashik, Maharashtra, India, 422010
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06440213
- Sponsor's protocol ID
- NRS/230703/PF/PDI
- Status last verified
- Mar 2025
- First submitted
- 30 Apr 2024
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06440213
- Acronym / sponsor ID
- NRS/230703/PF/PDI
- Conditions
- Pre Diabetes, Overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Nuritas LtdIndustry (pharma, biotech, devices)
- Study start
- 20 May 2024 (actual)
- Primary completion
- 22 Dec 2024 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 3 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Randomized, double-blind, placebo-controlled, parallel group study
| Arm | Type | Receives |
|---|---|---|
| PeptiControl™ (Low - Dose 435 mg/day) | Active comparator | Dietary Supplement: PeptiControl™ (Low - Dose 435 mg/day)6 capsules, 30 minutes prior to lunch every day for 6 days |
| PeptiControl™ (Mid - Dose 870 mg/day) | Active comparator | Dietary Supplement: PeptiControl™ (Mid - Dose 870 mg/day)6 capsules, 30 minutes prior to lunch every day for 6 days |
| PeptiControl™ (High - Dose 2610 mg/day) | Active comparator | Dietary Supplement: PeptiControl™ (High - Dose 2610 mg/day)6 capsules, 30 minutes prior to lunch every day for 6 days |
| Placebo Microcrystalline Cellulose | Placebo comparator | Dietary Supplement: Placebo Microcrystalline Cellulose6 capsules, 30 minutes prior to lunch every day for 6 days |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PeptiControl™ (Low - Dose 435 mg/day)Plant protein hydrolysate | Dietary supplement | PeptiControl™ (Low - Dose 435 mg/day) |
| PeptiControl™ (Mid - Dose 870 mg/day)Plant protein hydrolysate | Dietary supplement | PeptiControl™ (Mid - Dose 870 mg/day) |
| PeptiControl™ (High - Dose 2610 mg/day)Plant protein hydrolysate | Dietary supplement | PeptiControl™ (High - Dose 2610 mg/day) |
| Placebo Microcrystalline CellulosePlacebo MCC micro-crystalline cellulose | Dietary supplement | Placebo Microcrystalline Cellulose |
Primary outcome
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)
Time frame: Day 0 to Day 10
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.
9 secondary outcomes
To explore the safety of a range of doses of PeptiControl™ as assessed by a safety blood panel comparing baseline and post dose parameters.
Time frame: 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
Time frame: Day 0
To assess the efficacy of range of doses of PeptiControl™ on Glucose metabolism as assessed by incremental Area Under Curve (iAUC)
Time frame: Day 0
To assess the efficacy of range of doses of PeptiControl™ on Pancreatic efficiency
Time frame: Day 0 and Day 6
To assess the efficacy of range of doses of PeptiControl™ Time in range via CGM (Continuous Glucose Monitoring).
Time frame: Starting from day -2 and worn continuously until day 10 with readings taken at day -2, day 0, day 6, day 10
To assess the efficacy of range of doses of PeptiControl™ on Insulin sensitivity as assessed by Homeostatic Model Assessment for Insulin Resistance (HOMA-IR).
Time frame: Day 0 and Day 6
To assess the efficacy of range of doses of PeptiControl™ on Working memory as assessed by Paired Associate Learning test
Time frame: Day 0, Day 6, and Day 10
To assess the efficacy of range of doses of PeptiControl™ on Selective attention as assessed by Stroop test.
Time frame: Day 0, Day 6, and Day 10
To assess the efficacy of range of doses of PeptiControl™ on Hunger, satiety and fullness as assessed by the Visual Analog Scale (VAS)
Time frame: Day 0, Day 6, and Day 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Ravindra Kulkarni, MBBS,DNB,MD principal investigator
Ashwin Medical Foundation Pune, Maharashtra, India, 411033
Dr. Vishwajeet Gaikwad, MBBS, MD principal investigator
Imperial Multispecialty Hospital Pune, Maharashtra, India, 411062
Dr. Nilesh Tuplondhe, MBBS, MD principal investigator
Chopda Medicare & Research centre Nashik, Maharashtra, India, 422005
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Pre Diabetes and Overweight, run by Nuritas Ltd at 4 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: Day 0 to Day 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.