None listed
Conditions
Interventions
None listed
Sponsors
Amway Global Services India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1) Apparently healthy adults aged 30 to 50 years with normal blood pressure. 2) Participants meeting 2023 ADA guidelines, including fasting glucose levels of 100-125 mg per dl and HbA1c levels between 5.7 percent and 6 percent 3) Stable body mass with a BMI of less or equal30 kg per m2 4) No recent participation in other clinical trials within the past 3 months. 5) Individuals capable of understanding and committing to the study protocol, including follow-up visits.
Exclusion criteria
Exclusion criteria: 1) Current use of medication or Hormone Replacement Therapy (HRT). 2) Treatment with injectable therapies, including insulin, GLP 1 receptor agonists, SGLT 2 inhibitors, or metformin. 3) Allergies or intolerance to soy or wheat. 4) Diagnosed with endocrine hypothalamic-pituitary diseases, PCOS, adrenal disorders, or hypothyroidism. 5) Type 1 or Type 2 diabetes. 6) Reproductive-age women unwilling to use standard contraceptives. 7) Medical conditions such as CKD, stones, liver dysfunction, cancer history, eating disorders, chronic gastrointestinal disorders, hypertension, and cardiovascular diseases. 8) Active malignancy or remission for less than five years. 9) Recent surgical procedures within one month. 10) Participation in another clinical study within the past three months. 11) Doubts about the ability to comply with study procedures for mental, psychological, or social reasons. 12) Unwillingness to sign informed consent and adhere to the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of postprandial glycemic response of PRP-02 in adult individualsTimepoint: Assessment of postprandial glycemic response of PRP-02 by measuring blood sugar levels at predetermined intervals (-10, 15, 30, 45, 60, 90, and 120 minutes) in comparison to a reference product (glucose) on visit 2( Day 1) and visit 3( Day 4) | — |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence and severity of any adverse events during the study periodTimepoint: Baseline and End of the study | — |
Countries
India
Contacts
Public ContactDr Sudha Raj
Amway Global Services India Pvt Ltd
Outcome results
None listed