ENSO 16 - Study in Healthy Subjects
Condition: Sugar; Blood, Low
MeSH terms: Hypoglycemia
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      This is a randomized, double-blind, active-controlled, cross-over study to assess the effect
      of the sugar substitute "ENSO 16" on glucose metabolism parameters in healthy male or female
      subjects. 15 healthy subects ≥ 18 years will be included and 30 g of ENSO 16 or 30 g glucose
      will be orally administered to assess the impact on markers of glucose metabolism. The study
      medication will be dissolved in 200 mL tap water. After randomization, subjects will receive
      ENSO 16 (group A) or glucose (group B) on the first study day. Following a wash-out period of
      at least on week, subjects will receive glucose (group A) or ENSO 16 (group B) on the second
      study day. A screening examination (inclusion/ exclusion criteria, medical history, etc.)
      will be done on the first study day before the study medication will be administered. The
      study medication will be administered after an overnight fast of at least 10h. Subjects will
      receive a venular cannula and blood is going to be collected at 8 pre-defined timepoints (0 -
      15 - 30 - 45 - 60 - 90 - 120 - 180 minutes; 3 min at each time point). In total, 192 mL of
      blood are going to be collected per study participant. Study participants will also have to
      fill in a questionnaire to rate gastrointestinal symptoms using a checklist including the
      following questions: ((a) abdominal pain, (b) nausea, (c) vomiting, (d) diarrhoea, (e)
      abdominal rumbling, (f) bloating, (g) belching and (h) flatulence. Participants were asked to
      choose between "no symptom" (0 points), "mild symptoms" (1 point) and "severe symptoms" (2
      points) for each question at each time point.

      Primary Endpoint 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.

      Null and alternative hypotheses:

      H0: There is no difference in blood glucose AUC (0-60 min) between glucose and ENSO 16. H1:
      There is a difference in blood glucose AUC (0-60 min) between glucose and ENSO 16. Sample
      size calculation No formal sample size calculation could be performed for this trial as ENSO
      16 has never been tested on glucose metabolism parameters in a clinical trial. There is
      evidence that sugar substitutes have to be studied separately because sweeteners differ
      considerably in their chemical structure and their physiologic effect on glucose metabolism.
      However, based on a cross-over trial with the sugar substitute xylitol at high doses, a
      sample size of 12 was appropriate to detect significant differences in outcome parameters.
      Based on these study results and on available statistical recommendations, a sample size of
      15 was chosen, which is considered to be appropriate for this cross over trial to detect
      significant differences in the main outcome parameters if present. Statistical methodology
      Calculation of the AUC (0-60 min) for plasma glucose, insulin and Cpeptide profiles. Paired
      T-tests or Wilcoxon signed rank tests (for skewed distributions) will be applied to describe
      differences between treatments (glucose and ENSO 16)
    

Intervention name(s): ENSO 16; Glucose Powder
Intervention type(s): Drug; Drug
Intervention description(s): 30 g ENSO 16 dissolved in Water; 30 g Glucose Powder dissolved in Water
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 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.
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Sugar Substitutes; Fibers; Blood Glucose Rise; Blood Glucose Level; Polyols; Blood Glucose Spike