The effectiveness of NLSPL (Natural Life Speciality Pvt. Ltd) products on glycemic index and glycemic response in normal healthy adults: Prospective, Open label, Cross-over study

Not Applicable

Recruitment & Eligibility

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

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

Primary Outcome Measures

Name	Time	Method
To evaluate the glycemic index and glycemic response of NLSPL product Sugar (P1) in comparison to standard glucose (R1). <br/ ><br> <br/ ><br>To evaluate the glycemic index and glycemic response of NLSPL product Atta (P2) in comparison to standard glucose (R1). <br/ ><br> <br/ ><br>To evaluate the glycemic index and glycemic response of NLSPL product Jaggery (P3), in comparison to standard glucose (R1). <br/ ><br> <br/ ><br>To evaluate the glycemic index and glycemic response of NLSPL product Honey (P4) in comparison to standard glucose (R1). <br/ ><br>Timepoint: This is a cross over study with 7 scheduled visits with treatment duration of 1 day for each product. <br/ ><br>timepoint: <br/ ><br>Visit 2 and Visit 5: Standard Glucose (R1) <br/ ><br>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) <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
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. <br/ ><br>timepoint: <br/ ><br>Visit 2 & Visit 5: Standard Glucose (R1) <br/ ><br>Visit 3,Visit 4, Visit 6 & Visit 7: NLSPL product Sugar (P1), NLSPL product Atta (P2), NLSPL product Jaggery (P3),NLSPL product Honey (P4) <br/ ><br>