The effectiveness ofNLSPL products on glycemic index and glycemic response in normal healthy adults: Prospective, Open label, Cross-over study.

This is an open-label crossover study aiming to investigate the glycemic index, glycemic response, and safety of NLSPL products Sugar (P1), Atta (P2), Jaggery (P3), Honey (P4) in comparison to standard glucose (R1) as reference product. The study is planned to enroll a total of 12 normal healthy adults aged 18 to 45 years. Participants will receive comprehensive information regarding the nature and objectives of the study. The study procedures will begin only after obtaining written informed consent from the participant. The study investigator/study team will identify prospective participants based on the screening procedure and their qualifications against the study’s inclusion/exclusion criteria. Subjects satisfying the study eligibility criteria will be enrolled.

On screening day subject’s medical history, Demographic data (Age, Gender, Height, Weight, BMI), Random blood sugar (Finger Prick method), UPT kit (Only for females in child bearing age), vital signs (Heart rate, seated blood pressure, respiratory rate, body temperature), prior and concomitant medication and Physical examination will be done. While doing random blood sugar using finger-prick method participants in the study protocol will be encouraged to warm their hands before the finger-prick procedure to facilitate blood flow. Consistently, the third finger on the participant’s left hand will be utilized for finger-prick sampling during blood collection. Care will be taken to avoid fingertip blood extraction by refraining from squeezing, thereby preventing potential dilution of blood with plasma. Female volunteers will not be tested during menstrual period dates; testing will be rescheduled in such cases and in case of visits rescheduled beyond window period, a protocol deviation should be reported with appropriate reason.

After the screening visit, all subjects will undergo a comprehensive six-day testing regimen, comprising two days with the standard glucose (R1) and four days with the NLSPL product (IP)-Sugar (P1), Atta (P2), Jaggery (P3), and Honey (P4).

Subjects will be asked to visit the site at Visit 2, Visit 3, Visit 4, Visit 5, Visit 6, and Visit 7 after 12 hours of overnight fasting. Subjects will be gently reminded to avoid consuming any food or nutritional products, apart from water, before undergoing study procedures. During each visit, vital signs (Heart rate, seated blood pressure, respiratory rate, body temperature) and Prior and Concomitant medication (if any) will be done. Each Subject will then be instructed to consume the standard glucose (R1) during designated visits (visit 2 and visit 5) and NLSPL Products (IP) - Sugar (P1), Atta (P2), Jaggery (P3), and Honey (P4) during visit 3, visit 4, visit 6 and visit 7.

To evaluate the performance of the IP, venous blood sugar measurements will be taken as Fasting Blood Sugar (FBS) at 0 minutes before product administration, followed by assessments at 15, 30, 60, 90, 120-, and 150-minutes post-administration during visits 2, Visit 3, visit 4, visit 5, visit 6 and visit 7/End of study, as outlined in the schedule of events. A minimum washout period of two days will be implemented between measurements to mitigate potential carry-over effects effectively. At the end of 16 days for all 12 subjects, data will be statistically analyzed and changes in FBG and blood sugar level will be estimated as a trend in comparison for the estimation of glycemic index of NLSPL products Sugar (P1), Atta (P2), Jaggery (P3), and Honey (P4).

Study details include:

·         The study duration will be up to 16 days.

·         The treatment duration will be up to 1 day for each product in a cross over manner.

·         The visits frequency will include 7 scheduled physical visits