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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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30 May 2022 |
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Main ID: |
NCT02821923 |
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Date of registration:
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27/06/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effect of the Natural Sweeteners Erythritol and Xylitol on Vascular Function in Obese Volunteers
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Scientific title:
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Effect of the Natural Sweeteners Erythritol and Xylitol on Vascular Function in Obese Volunteers: A Pilot Study |
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Date of first enrolment:
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November 7, 2016 |
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Target sample size:
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42 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02821923 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: Double (Participant, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Switzerland
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Contacts
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Name:
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Christoph Beglinger, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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St. Claraspital Basel klinische Forschungsabteilung |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Obese volunteers (BMI > 30kg/m2)
- Aged 18- max. 55 years
- Otherwise healthy.
Exclusion Criteria:
- Known cardiovascular disease
- Diabetes mellitus
- Smoking and drug abuse
- Arterial hypertension with antihypertensive treatment
- Dyslipidaemia with statin therapy
- Known chronic hepatic disease (NASH, hepatitis).
- Known renal disease: kidney failure
- Pregnancy
- Chronical diseases of the gastrointestinal tract, history of gastrointestinal surgery
with major changes to the gastrointestinal tract
- Substance abuse, alcohol abuse.
- Inability to follow procedures due to psychological disorders, dementia or
insufficient knowledge of project language (German).
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Obesity
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Intervention(s)
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Dietary Supplement: E968-Erythritol
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Dietary Supplement: E967-Xylitol
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Primary Outcome(s)
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Central arterial stiffness measured by sonography
[Time Frame: Change from baseline to 5 weeks after intake of polyol]
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Secondary Outcome(s)
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Glucose tolerance measured by oral glucose tolerance test
[Time Frame: Change from baseline to 5 weeks after intake of polyol]
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Secondary ID(s)
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Poly Vasc
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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