A clinical study to determine the blood glucose response in healthy volunteers
- Registration Number
- CTRI/2018/06/014355
- Lead Sponsor
- Signutra Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Males or females in the age 18- 65 years (both inclusive).
2.Be of normal health as determined by the investigator from medical history, clinical and physical examination.
3.Random blood sugar level <= 200 mg/dl at screening.
4.BMI between 18.5 to 25 kg/m2 (both inclusive).
5.Must be willing to or likely to comply with all study requirements.
6.Must be able and willing to provide written informed consent.
7.Women of childbearing potential should have a negative pregnancy test at the time of screening and agree to use contraception during the study.
Exclusion criteria
Patients meeting any of the following exclusion criteria will not be eligible for participation in this trial:
1.Age less than 18yrs and greater than 65yrs
2.Previous history of any clinically significant medical condition e.g. cardiovascular, type 2 diabetes mellitus, eating disorder or serious gastrointestinal indications which in opinion of investigator may jeopardize subjectâ??s safety and preclude trial participation.
3.Use of antihyperglycemic drugs or insulin to treat diabetes and related conditions
4.Suffering from any condition which may interfere with nutrient absorption, distribution, metabolism and excretion in opinion of the Investigator e.g. subacute obstruction.
5.Current use of medication (eg steroids, protease inhibitors or antipsychotics, etc.) which may interfere with the digestion and nutrient absorption or affect glucose tolerance and estimation in opinion of the Investigator.
6.Abuse of drugs or alcohol.
7.Known case of sensitivity to Gluten or Coeliac disease.
8.Pregnant or lactating women.
9.Currently participating or had participated in any other interventional study in last 1 month prior to screening.
10.Patients who are unlikely to comply with protocol requirements (e.g. non-cooperative behavior, illiterate, inability to attend study visits required by the protocol).
Patients meeting any of the following exclusion criteria will not be eligible for participation in this trial:
1.Age less than 18yrs and greater than 65yrs
2.Previous history of any clinically significant medical condition e.g. cardiovascular, type 2 diabetes mellitus, eating disorder or serious gastrointestinal indications which in opinion of investigator may jeopardize subjectâ??s safety and preclude trial participation.
3.Use of antihyperglycemic drugs or insulin to treat diabetes and related conditions
4.Suffering from any condition which may interfere with nutrient absorption, distribution, metabolism and excretion in opinion of the Investigator e.g. subacute obstruction.
5.Current use of medication (eg steroids, protease inhibitors or antipsychotics, etc.) which may interfere with the digestion and nutrient absorption or affect glucose tolerance and estimation in opinion of the Investigator.
6.Abuse of drugs or alcohol.
7.Known case of sensitivity to Gluten or Coeliac disease.
8.Pregnant or lactating women.
9.Currently participating or had participated in any other interventional study in last 1 month prior to screening.
10.Patients who are unlikely to comply with protocol requirements (e.g. non-cooperative behavior, illiterate, inability to attend study visits required by the protocol).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Determination of glycemic index value of Vidavance TMTimepoint: 2 Months
- Secondary Outcome Measures
Name Time Method To to determine the effect of Vidavance TM on satiety ratings in healthy subjects <br/ ><br>To assess safety and tolerability of Vidavance TM in healthy volunteers <br/ ><br>Timepoint: 2 Months