A study to find glycemic index of pronocte protein powder in healthy humans

Phase 3

Completed

• Registration Number: CTRI/2022/02/040477
• Lead Sponsor: Azista Industries Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-03-31
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 13

Inclusion Criteria

Normal healthy, adult subjects between 18-45 years of age, who voluntarily give their consent to participate in this trial.

Exclusion Criteria

1. History or presence of significant:

- Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease.

- Alcohol dependence, alcohol abuse or drug abuse within the past one year.

- Moderate to heavy smoking ( >10 cigarettes/day) or consumption of tobacco products.

- Asthma, urticaria or other allergic type reactions after taking any medication.

2. Subjects who, through completion of the study, would have donated in excess of 500 ml of blood in 60 days or 450 ml in 10 week period or more than 900 ml of blood in 20 week period.

3. Subjects who have participated in another clinical trial within 60 days of study start.

4. Subjects who have (1) a Systolic blood pressure less than 90 mm of Hg and higher than 150 mm of Hg (2) Diastolic blood pressure less than 60 mm of Hg and more than 95 mm of Hg (3) Pulse rate below 50 / min. and above 105/min. Minor deviations (1-3 mm Hg) at check-in may be acceptable at the discretion of the physician / investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incremental area under the curveTimepoint: 30 min Before dosing, and at 0, 15, 30, 45, 60, 90 and 120 minutes

Secondary Outcome Measures

Name	Time	Method
Adverse eventsTimepoint: End of each study period