ENSO 16 - Study in Healthy Subjects

NCT05457400 | Completed Phase 1 DMC

• 1 other identifier: 00070007
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sugar; Blood, Low

Keywords

Sugar Substitutes; Fibers; Blood Glucose Rise; Blood Glucose Level; Polyols; Blood Glucose Spike

Outcome Measures

Primary Outcomes (1)

• Effect on blood sugar

  To test the effect of orally administered ENSO 16 (30 g) or glucose (30 g) on plasma glucose levels. The area under the curve (AUC) of plasma glucose profiles (0-60 min) will be compared between different study days.

  2 weeks

Study Arms (2)

ENSO 16

ACTIVE COMPARATOR

The participants receive 30g ENSO 16 dissolved in 200 mL water and blood will be collected at defined time points (0 - 15 - 30 - 45 - 60 - 90 - 120 - 180 minutes; ±3 min at each time point).

Drug: ENSO 16

Glucose Powder

ACTIVE COMPARATOR

The participants receive Glucose in the same dosage and blood is also taken at the same time points.

Drug: Glucose Powder

Interventions

ENSO 16 DRUG

30 g ENSO 16 dissolved in Water

ENSO 16

Glucose Powder DRUG

30 g Glucose Powder dissolved in Water

Glucose Powder

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Alpha Republic GmbH: lead
• Vienna General Hospital: collaborator

Study Sites (1)

Universitätsklinik für Klinische Pharmakologie,

Vienna, 1090, Austria

Location

Related Publications (1)

• Lutnik M, Weisshaar S, Mussbacher LM, Steiner D, Wolzt M. The substitute ENSO 16 has low impact on glucose metabolism in healthy humans: a randomized, double-blind, active-controlled, cross-over trial. Sci Rep. 2024 Jun 24;14(1):14534. doi: 10.1038/s41598-024-65560-w.

  PMID: 38914694 DERIVED

MeSH Terms

Conditions

Hypoglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The study medication will be provided in identical looking bottles. Because of the completely identical appearance and smell (white, powdery substance and sweet smell), no difference can be perceived by the investigators or subjects. The bottles will be labelled with the respective labels as shown in chapter 8.1.6. Unblinding will be performed after the database lock (e.g. all pseudonymized data for statistical analysis entered into an Excel and/or SPSS sheet). Emergency envelopes will be provided from the sponsor to the Department of Clinical Pharmacology if emergency unblinding is necessary.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: July 14, 2022
• Study Start: April 28, 2022
• Primary Completion: June 14, 2022
• Study Completion: July 29, 2022
• Last Updated: February 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR

Locations

AU (1)