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

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ClinicalTrials.gov Identifier: NCT04966299
Recruitment Status : Recruiting
First Posted : July 19, 2021
Last Update Posted : October 5, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

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
Insulin Resistance Glucose Tolerance Body Composition Gastrointestinal Tolerance Dietary Supplement: Eryhtritol Dietary Supplement: Sucrose Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : August 18, 2021
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Sucrose

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 Name: E968-Erythritol




Primary Outcome Measures :
  1. Insulin resistance [ Time Frame: 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 [ Time Frame: Change from baseline to 5 weeks after polyol/sucrose intake ]
    Insulin levels during OGTT

  2. Glucose tolerance: Glucose [ Time Frame: Change from baseline to 5 weeks after polyol/sucrose intake ]
    Glucose levels during OGTT

  3. Glucose tolerance: C-Peptide [ Time Frame: Change from baseline to 5 weeks after polyol/sucrose intake ]
    C-peptide levels during OGTT

  4. Glucose tolerance: Glucagon [ Time Frame: Change from baseline to 5 weeks after polyol/sucrose intake ]
    Glucagon levels during OGTT

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

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

  7. Glucose tolerance: Continuous glucose monitoring average [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Change from baseline to 5 weeks after polyol/sucrose intake ]
    Continuous glucose monitoring for time within range

  10. Glucose absorption [ Time Frame: Change from baseline to 5 weeks after polyol/sucrose intake ]
    Glucose absorption measured by 3-OMG concetrations during OGTT

  11. Metabolomics [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Change from baseline to 5 weeks after polyol/sucrose intake ]
    Secretion of GLP-1 during OGTT

  14. Gastrointestinal hormones secretion: PYY [ Time Frame: Change from baseline to 5 weeks after polyol/sucrose intake ]
    Secretion of PYY during OGTT

  15. Gastrointestinal hormones secretion: Ghrelin [ Time Frame: Change from baseline to 5 weeks after polyol/sucrose intake ]
    Secretion of Ghrelin during OGTT

  16. Gastrointestinal hormones secretion: CCK [ Time Frame: Change from baseline to 5 weeks after polyol/sucrose intake ]
    Secretion of CCK during OGTT

  17. Food intake [ Time Frame: Change from baseline to 5 weeks after polyol/sucrose intake ]
    Food intake assessed with self-reported food records

  18. Gastrointestinal tolerance [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Change from baseline to 5 weeks after polyol/sucrose intake ]
    Body composition assessed by mean of bioimpedance analysis: fat free mass in kg



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04966299


Contacts
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Contact: Bettina K. Wölnerhanssen, PD. MD + 41 61 685 86 32 bettina.woelnerhanssen@claraspital.ch
Contact: Anne Christin Meyer-Gerspach, PD. PhD +41 61685 86 44 annechristin.meyergerspach@unibas.ch

Locations
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Switzerland
St. Claraspital Recruiting
Basel, Basel-Stadt, Switzerland, 4002
Contact: Bettina K. Wölnerhanssen, PD. MD    +41 61 685 86 32    bettina.woelnerhanssen@claraspital.ch   
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Bettina K. Wölnerhanssen, PD. MD St. Clara Research Ltd.
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT04966299    
Other Study ID Numbers: EryAdo
First Posted: July 19, 2021    Key Record Dates
Last Update Posted: October 5, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Erythritol
Vasodilator Agents