NCT01609088

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started May 2012

Shorter than P25 for not_applicable type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

May 25, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 31, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

July 24, 2013

Status Verified

July 1, 2013

Enrollment Period

7 months

First QC Date

May 25, 2012

Last Update Submit

July 23, 2013

Conditions

Type 2 Diabetes Mellitus

Keywords

endotheliumdiabetes mellitusoxidative stress

Outcome Measures

Primary Outcomes (1)

  • Brachial artery flow mediated dilation

    Change from baseline at 28 days

Secondary Outcomes (6)

  • Brachial artery flow-mediated dilation

    Change from baseline at 2 hours

  • Reactive hyperemia

    Change from baseline at 2 hours and 28 days

  • Carotid femoral pulse wave velocity

    Change from baseline at 28 days

  • Fingertip tonometry

    Change from baseline at 2 hours and 28 days

  • Urine F2 isoprostanes

    Change from baseline at 28 days

  • +1 more secondary outcomes

Study Arms (1)

Erythritol-containing beverage

EXPERIMENTAL
Dietary Supplement: Erythritol-containing beverage

Interventions

Erythritol-containing beverageDIETARY_SUPPLEMENT

Orange flavored beverage containing erythritol

Erythritol-containing beverage

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes mellitus
  • Otherwise healthy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston University School of Medicine

Boston, Massachusetts, 02118, United States

Location

Related Publications (1)

  • Flint N, Hamburg NM, Holbrook M, Dorsey PG, LeLeiko RM, Berger A, de Cock P, Bosscher D, Vita JA. Effects of erythritol on endothelial function in patients with type 2 diabetes mellitus: a pilot study. Acta Diabetol. 2014;51(3):513-6. doi: 10.1007/s00592-013-0534-2. Epub 2013 Dec 24.

    PMID: 24366423DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Joseph A. Vita, MD

    Boston University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

May 25, 2012

First Posted

May 31, 2012

Study Start

May 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

July 24, 2013

Record last verified: 2013-07

Locations

US(1)