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Pilot Study of the Effects of Erythritol on Endothelial Function in Patients With Type 2 Diabetes Mellitus

Pilot Study of the Effects of Erythritol on Endothelial Function in Patients With Type 2 Diabetes Mellitus

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01609088
Enrollment
24
Registered
2012-05-31
Start date
2012-05-31
Completion date
2012-12-31
Last updated
2013-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

endothelium, diabetes mellitus, oxidative stress

Brief summary

The study will determine whether acute and chronic consumption of a beverage containing erythritol will improve endothelial function in patients with type 2 diabetes mellitus.

Interventions

DIETARY_SUPPLEMENTErythritol-containing beverage

Orange flavored beverage containing erythritol

Sponsors

Cargill
CollaboratorINDUSTRY
Boston University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
35 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Type 2 diabetes mellitus * Otherwise healthy

Exclusion criteria

* Pregnant * BMI\>35 kg/m2 * Long acting insulin treatment * Other major illness, drug abuse * Treatment with an investigational drug within 12 weeks * Treatment with dietary or vitamin supplements * Smoking within 3 months

Design outcomes

Primary

MeasureTime frame
Brachial artery flow mediated dilationChange from baseline at 28 days

Secondary

MeasureTime frameDescription
Brachial artery flow-mediated dilationChange from baseline at 2 hoursReactive hyperemia, carotid femoral pulse wave velocity, fingertip tonometry.
Reactive hyperemiaChange from baseline at 2 hours and 28 days
Carotid femoral pulse wave velocityChange from baseline at 28 days
Fingertip tonometryChange from baseline at 2 hours and 28 days
Urine F2 isoprostanesChange from baseline at 28 days
C-reactive proteinChange from baseline at 28 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026