Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: NE-S01: Subjects will be advised to
consume 1 bottle of 400 ml
NE-S01 orally throughout day
for 14 days as a nutritional
supplement.
Control Intervention1: NIL: NIL
Sponsors
Naturedge Beverages Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subject of age 18 to 60 years has a B.W in between 45 to 75 kg. 2. Subject is a non-smoker. 3. Subject is in good health and appropriate for exercise. 4. Subjects with diabetes mellitus type 2 with fasting blood sugar between 120-180 mg/dl with or without ongoing oral hypoglycemic agents 5. Subject agrees to not use any new vitamins and/or minerals until after study completion and to not take any vitamins and/or minerals 24 hours prior to the test visits. 6. Subject agrees to not use any dietary or herbal supplements until after study completion. A 7-day washout is allowed for study inclusion. 7. Subject is willing and able to comply with the protocol including: Attending 3 visits; Refraining from caffeine, over-the-counter medications and alcohol for the 24 hours prior to the test visits; Refraining from taking any dietary or herbal supplements throughout the study. 8. Subject is able to understand and sign the informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: The subjects will be excluded based on the following criteria during screening and during the study. 1. Subjects with or prior history or presence of clinically significant Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease. 2. Subject has any orthopedic problem(s) or history of musculoskeletal injury(ies). 3. Subject has a history of cancer (except localized skin cancer without metastases) within 5 years prior to screening. 4. No prescription or chronic medication use allowed without PI discretion. 5. Subject has an allergy to any of the ingredients in the test product. 6. Subject is currently taking and unwilling to refrain from taking any over-the-counter stimulant medications/ supplements; seven-day washout required for study inclusion. 7. Subject is currently taking and unwilling to refrain from taking any over-the-counter allergy or asthma medication containing pseudoephedrine or ephedrine; seven-day washout required for study inclusion. 8. Subject reports being a regular caffeine consumer defined as consuming > 600 mg of caffeine per day. 9. Subject has a clinically relevant abnormality as defined by the PI or interpreting physician with respect to the physical examination. 10. Subject has a history of drug or alcohol abuse in the past 12 months. 11. Subject has any condition or abnormality that, in the opinion of the investigator, would compromise the safety of the subject or the quality of the study data. 12. Subject with type 1 diabetes 13. Subjects receiving insulin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Plasma glucose levels fasting and post 2 hr meal for diabetic population 2.Rating of perceived exertion score at baseline and end of study 3.Self-efficacy For Exercise (SEE) Scale at baseline and end of study 4.Subjective Vitality Score at baseline and end of study 5.Perceived Stress Scale at baseline and end of study 6.satisfaction with life score at baseline and end of studyTimepoint: Baseline, Visit 1 (Day 7), Visit 2 (Day 14) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Tolerance of NE-S01 by patients 2.Global evaluation for overall improvement by physician and subject 3.Adverse events in diabetic population armTimepoint: Baseline, Visit 1 (Day 7), Visit 2 (Day 14) | — |
Countries
India
Contacts
Public ContactDr Veena Deo
Naturedge Beverages Pvt. Ltd.
Outcome results
None listed