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

Launched by NURITAS LTD · May 28, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating the safety and tolerability of a plant-based ingredient called PeptiControl in individuals who are pre-diabetic and overweight. The study aims to understand how different doses of this ingredient affect blood sugar levels and overall health in people aged 30 to 60, with a Body Mass Index (BMI) between 25 and 33. Eligible participants must have specific fasting blood glucose levels and be non-smokers. They should also have maintained a stable weight for the last three months and be willing to wear a continuous glucose monitor during the study.

If you join this trial, you’ll be randomly assigned to receive either PeptiControl or a placebo (a treatment that doesn’t contain the active ingredient) while ensuring you keep your usual diet and exercise. Throughout the study, you’ll need to attend regular visits to the site, where you’ll provide blood samples and follow specific guidelines. This is a great opportunity to contribute to research that may help improve health outcomes for those at risk of diabetes.

Gender

ALL

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.

Trial Officials