ENSO 16 - Study in Healthy Subjects

• Status: Recruiting
• Trial end date: 2022-07-29
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to evaluate differences in glucose metabolism parameters after oral administration of 30g glucose or 30g ENSO16. Blood samples will be be collected from 15 male or female subjects at defined time points (0 - 15 - 30 - 45 - 60 - 90 - 120

• 180 minutes; 3 min at each time point). Individual plasma glucose, insulin and C-peptide concentrations are going to be evaluated and statistically assessed. Subjects will also be asked to complete a questionnaire regarding their digestion after oral intake of ENSO 16 or glucose defined timepoints.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Alpha Republic GmbH
• Collaborator: Vienna General Hospital

Criteria

Inclusion Criteria:

• Ability of subject to understand the character and individual consequences of the study;

• Signed informed consent before the start of any specific study procedures;

• Age ≥18 years;

• BMI 18-25 and healthy

• Fasting blood glucose ≤ 100mg/dL (point of care device)

Exclusion Criteria:

• Substance or alcohol abuse

• Smoking

• Regular intake of medication (except oral contraceptives) including over the counter drugs within 2 weeks before study day 1

• Chronic medical illness

• Food allergies and dietary restrictions

• Pregnancy

• Participation in another clinical trial 3 weeks before study day 1