None listed
Conditions
Interventions
Intervention1: Sugar (P1): Investigational Product 1 Name: NLSPL Sugar (P1)
Investigational Product Packaging: Pouch
Form: Granules
Dose: 50 gms
Administration:Each subject will be administered as
Sponsors
Natural Life Speciality Pvt. Ltd (NLSPL).
Eligibility
Inclusion criteria
Inclusion criteria: To be eligible for this trial, subjects must fulfill all inclusion criteria listed below: 1. Healthy Males and/or Female subjects with the age group 18 to 45 years. 2. The subject should be not obese with a Body mass index (BMI) in the range =18.5 to = 24.9 3. 3.The subject should be willing to refrain from smoking, alcohol, and caffeine containing drinks during the study period. 4. The subject should be willing to comply with study protocol requirements including adherence to diet and lifestyle modifications. 5. Subject with random blood sugar = 200 mg/dl 6. The subject should be willing to provide a voluntary written informed consent.
Exclusion criteria
Exclusion criteria: Subject meeting any of the following exclusion criteria will not be eligible for participation in this trial: 1. Diabetic Individual, type I/II diabetics, Gestational Diabetes 2. Subject who has been diagnosed to have acute infections like viral fever, typhoid, cold, diarrhea within one month prior to enrollment. 3. Subject with a history of complications such as respiratory disorders, cancer or heart attack and stroke 4. History of malignancy in the past 1 year. 5. Having an eating disorder 6. History of hypoglycemia in last 3 months 7. Taking any herbal/Ayurveda/Traditional preparation that could profoundly affect blood glucose 8. Pregnant and lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the glycemic index and glycemic response of NLSPL product Sugar (P1) in comparison to standard glucose (R1). To evaluate the glycemic index and glycemic response of NLSPL product Atta (P2) in comparison to standard glucose (R1). To evaluate the glycemic index and glycemic response of NLSPL product Jaggery (P3), in comparison to standard glucose (R1). To evaluate the glycemic index and glycemic response of NLSPL product Honey (P4) in comparison to standard glucose (R1). Timepoint: This is a cross over study with 7 scheduled visits with treatment duration of 1 day for each product. timepoint: Visit 2 and Visit 5: Standard Glucose (R1) Visit 3,Visit 4, Visit 6 and Visit 7: NLSPL product Sugar (P1), NLSPL product Atta (P2), NLSPL product Jaggery (P3),NLSPL product Honey (P4) | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety of NLSPL Sugar (P1), Atta (P2), Jaggery (P3), Honey (P4) products in subjects.Timepoint: This is a cross over study with 7 scheduled visits with treatment duration of 1 day for each product. timepoint: Visit 2 & Visit 5: Standard Glucose (R1) Visit 3,Visit 4, Visit 6 & Visit 7: NLSPL product Sugar (P1), NLSPL product Atta (P2), NLSPL product Jaggery (P3),NLSPL product Honey (P4) | — |
Countries
India
Contacts
Public ContactDr Ruchi Joshi
CRO-Jehangir Clinical Development Centre
Outcome results
None listed