EryAdo: Effect of Daily Erythritol Versus Sucrose Intake Over 5 Weeks on Glucose Tolerance in Adolescents

Sponsor
University Hospital, Basel, Switzerland (Other)
Overall Status
Recruiting
CT.gov ID
NCT04966299
Collaborator
(none)
30
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2
23.4
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Study Details

Study Description

Brief Summary

Childhood and adolescence are crucial periods for prevention of obesity, as obese children are five times more likely to be obese at adulthood than lean children. To this purpose, sugar consumption should be reduced. The sugar alcohol erythritol is increasingly popular as sugar substitute in the food industry and is also recommended to diabetic patients. The substance is freely available. Recent acute studies show that erythritol has a positive influence on satiation and gastric emptying without affecting insulin and plasma glucose. In this trial, the investigators aim to assess the effect of a chronic intake of erythritol versus sucrose on insulin resistance in healthy adolescents.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Eryhtritol
  • Dietary Supplement: Sucrose
N/A

Detailed Description

This trial aims to assess the effects of the daily intake of an erythritol-sweetened beverage over 5 weeks on insulin resistance, glucose tolerance and metabolism as well as on gut microbiota. Moreover, this study will also assess the effect of the above-mentioned intervention on food intake, body composition and gastrointestinal tolerance in this population.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Effect of Daily Erythritol Versus Sucrose Intake Over 5 Weeks on Glucose Tolerance in Adolescents: a Pilot Trial
Actual Study Start Date :
Aug 18, 2021
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Sucrose

15 participants receive 25g sucrose per day during 5 weeks

Dietary Supplement: Sucrose
Sucrose-sweetened beverages twice a day (25g sucrose/day) with main meals during 5 weeks

Experimental: Erythritol

15 participants receive 36g eryhtritol per day during 5 weeks

Dietary Supplement: Eryhtritol
Eryhtritol-sweetened beverages twice a day (36g erythritol/day) with main meals during 5 weeks
Other Names:
  • E968-Erythritol
  • Outcome Measures

    Primary Outcome Measures

    1. Insulin resistance [Change from baseline to 5 weeks after polyol/sucrose intake]

      Insulin resistance as measured by the HOMA Index.

    Secondary Outcome Measures

    1. Glucose tolerance: Insulin [Change from baseline to 5 weeks after polyol/sucrose intake]

      Insulin levels during OGTT

    2. Glucose tolerance: Glucose [Change from baseline to 5 weeks after polyol/sucrose intake]

      Glucose levels during OGTT

    3. Glucose tolerance: C-Peptide [Change from baseline to 5 weeks after polyol/sucrose intake]

      C-peptide levels during OGTT

    4. Glucose tolerance: Glucagon [Change from baseline to 5 weeks after polyol/sucrose intake]

      Glucagon levels during OGTT

    5. Glucose tolerance: Fructosamin [Change from baseline to 5 weeks after polyol/sucrose intake]

      Fructosamin levels

    6. Glucose tolerance: HbA1C [Change from baseline to 5 weeks after polyol/sucrose intake]

      HbA1C levels

    7. Glucose tolerance: Continuous glucose monitoring average [Change from baseline to 5 weeks after polyol/sucrose intake]

      Continuous glucose monitoring for average glucose levels

    8. Glucose tolerance: Continuous glucose monitoring glucose variability [Change from baseline to 5 weeks after polyol/sucrose intake]

      Continuous glucose monitoring for glucose variability

    9. Glucose tolerance: Continuous glucose monitoring time within range [Change from baseline to 5 weeks after polyol/sucrose intake]

      Continuous glucose monitoring for time within range

    10. Glucose absorption [Change from baseline to 5 weeks after polyol/sucrose intake]

      Glucose absorption measured by 3-OMG concetrations during OGTT

    11. Metabolomics [Change from baseline to 5 weeks after polyol/sucrose intake]

      Metabolomics in plasma, urine and stool samples, measured by 1H-NMR and Liquid Chromatography-Mass Spectrometry (LC-MS).

    12. Gut microbiota composition [Change from baseline to 5 weeks after polyol/sucrose intake]

      The taxonomic and functional profiles of the gut microbiota (stool samples) assessed by metagenomic shotgun sequencing.

    13. Gastrointestinal hormones secretion: GLP-1 [Change from baseline to 5 weeks after polyol/sucrose intake]

      Secretion of GLP-1 during OGTT

    14. Gastrointestinal hormones secretion: PYY [Change from baseline to 5 weeks after polyol/sucrose intake]

      Secretion of PYY during OGTT

    15. Gastrointestinal hormones secretion: Ghrelin [Change from baseline to 5 weeks after polyol/sucrose intake]

      Secretion of Ghrelin during OGTT

    16. Gastrointestinal hormones secretion: CCK [Change from baseline to 5 weeks after polyol/sucrose intake]

      Secretion of CCK during OGTT

    17. Food intake [Change from baseline to 5 weeks after polyol/sucrose intake]

      Food intake assessed with self-reported food records

    18. Gastrointestinal tolerance [Change from baseline to 3 and 5 weeks after polyol/sucrose intake]

      Gastrointestinal tolerance recorded by the "Gastrointestinal Symptoms Rating Scale" (GSRS), 15 items rated on 7 Point Likert-Scale, a higher score means a worse outcome. Maximum score: 90, Minimum score: 0

    19. Body composition: fat mass [Change from baseline to 5 weeks after polyol/sucrose intake]

      Body composition assessed by mean of bioimpedance analysis: fat mass in kg

    20. Body composition: fat free mass [Change from baseline to 5 weeks after polyol/sucrose intake]

      Body composition assessed by mean of bioimpedance analysis: fat free mass in kg

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    14 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Healthy adolescents

    • Aged 14-18 years

    • Normal weight (BMI between 15th and 85th percentile for age and gender)

    • Minimum weight of 45kg

    • Regular sugar consumption >25g/d

    Exclusion Criteria:
    • Severe acute or chronic diseases

    • Pregnancy

    • Regular intake of prebiotics

    • Regular intake of probiotics

    • Regular intake of pro-/prebiotic foods

    • Antibiotics cure within 3 months preceding the present study

    • Substance abuse

    • Inability to follow procedures due to psychological disorders or insufficient knowledge of project language (German)

    • Participation in another study with investigational drug within the 30 days preceding and during the present study.

    • Pre-existing regular consumption (>1/week) of erythritol

    • Fructose-intolerance

    • Pre-existing diet (vegetarian, vegan, gluten-free, lactose-free, caloric restriction, etc.)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 St. Claraspital Basel Basel-Stadt Switzerland 4002

    Sponsors and Collaborators

    • University Hospital, Basel, Switzerland

    Investigators

    • Principal Investigator: Bettina K. Wölnerhanssen, PD. MD, St. Clara Research Ltd.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Basel, Switzerland
    ClinicalTrials.gov Identifier:
    NCT04966299
    Other Study ID Numbers:
    • EryAdo
    First Posted:
    Jul 19, 2021
    Last Update Posted:
    Oct 5, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 5, 2021