Assessment of Postprandial Glycemic Response to PRP-02 in Individuals with Compromised Blood Glucose Levels: A non-randomized, Controlled, Crossover Study
Trial Snapshot
- Phase
- Phase 3 4
- Status
- Completed
- Sponsor
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Assessment of postprandial glycemic response of PRP-02 in adult individuals
Study Overview
Brief Summary
Postprandial glycaemic response refers to the changes in blood sugar levels after consuming a meal. PRP-02 seems to be a substance or intervention being tested in the trial
During acute feeding trials, consuming a large dose of whey protein (WP) before meals improves postprandial glucose regulation in people with type 2diabetes. It is unclear if the reported benefits of premeal WP supplementation are translatable to everyday care or are associated with clinically meaningful, real-world glycemic outcomes.
This study examined the application of a novel, premeal shot containing a low dose of WP on parameters of free-living glycemic control in people Healthy volunteers .
Purpose: The purpose of the trial appears to be evaluating the impact of PRP-02 on postprandial glycemic response in individuals with compromised blood glucose levels. This kind of study aims to assess whether the intervention (PRP-02) has an effect on how the body handles blood sugar levels after eating
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 30.00 Year(s) to 50.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Apparently healthy adults aged 30 to 50 years with normal blood pressure.
- •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.
- •Individuals capable of understanding and committing to the study protocol, including follow-up visits.
Exclusion Criteria
- •Current use of medication or Hormone Replacement Therapy (HRT).
- •Treatment with injectable therapies, including insulin, GLP 1 receptor agonists, SGLT 2 inhibitors, or metformin.
- •Allergies or intolerance to soy or wheat.
- •Diagnosed with endocrine hypothalamic-pituitary diseases, PCOS, adrenal disorders, or hypothyroidism.
- •Type 1 or Type 2 diabetes.
- •Reproductive-age women unwilling to use standard contraceptives.
- •Medical conditions such as CKD, stones, liver dysfunction, cancer history, eating disorders, chronic gastrointestinal disorders, hypertension, and cardiovascular diseases.
- •Active malignancy or remission for less than five years.
- •Recent surgical procedures within one month.
- •Participation in another clinical study within the past three months.
- •Doubts about the ability to comply with study procedures for mental, psychological, or social reasons.
- •Unwillingness to sign informed consent and adhere to the study protocol.
Outcomes
Primary Outcomes
Assessment of postprandial glycemic response of PRP-02 in adult individuals
Time Frame: 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 Outcomes
- Occurrence and severity of any adverse events during the study period(Baseline and End of the study)
Investigators
Dr Madhu Sudan C
NRR Hospital