Functional drink NE-S01 in improving wellbeing and stamina
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2019/12/022553
- Lead Sponsor
- aturedge Beverages Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method