Dose-Dependent Effects of Erythritol on Endothelial Function in Type 2 Diabetes Mellitus

NCT ID: NCT01908348

Last Updated: 2018-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-18
• Study Completion Date: 2016-12-31

Brief Summary

This study is an open-label pilot designed to examine the dose-dependent effects of erythritol, a zero calorie sweetener, on endothelial function. Twenty-four subjects with type 2 diabetes mellitus will make three study visits. At each visit, the will consume an orange-flavored beverage containing escalating amounts of erythritol (6, 12, and 18 grams). Endothelial function will be assessed before and two hours after beverage consumption. Endothelial function will be measured as the change in pulse amplitude in response to reactive hyperemia measured in the fingertip by peripheral arterial tonometry. The results will be used to plan a randomized, placebo-controlled study.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Erythritol

Orange-flavored beverage containing 6, 12, or 18 grams of erythritol

Group Type: EXPERIMENTAL

Erythritol

Intervention Type: DIETARY_SUPPLEMENT

Interventions

Erythritol

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Male and Female subjects
• Otherwise healthy patients with Type 2 diabetes mellitus as defined by fasting blood glucose >125 mg/dl or with ongoing treatment for Type 2 diabetes mellitus with the exception of insulin.

Exclusion Criteria

• Women with a positive urine pregnancy test
• Body mass index >35 kg/m2
• Current daily long-acting insulin therapy (short acting, insulin as needed is not an exclusion).
• Clinical history of other major illness including cancer, renal failure, hepatic failure, or other conditions that in the judgment of the principal investigator make a clinical study inappropriate.
• Treatment with an investigational drug within the last twelve weeks
• History of a psychological illness or condition such as to interfere with the subject's ability to understand the requirements of the study.
• Treatment with vitamin E, vitamin C, and beta carotene, lipoic acid, and other food or herbal supplements within 1 month of enrollment. Subjects taking multivitamins or other forms of vitamin E and C in doses that do not exceed two times the recommended daily allowance will not be excluded.
• Recent change in diet or level of physical activity that in the judgment of the investigators would be likely to affect endothelial function (to be evaluated on a case by case basis).
• Ongoing illicit drug use or alcohol abuse.
• Sensitivity/intolerance to dietary polyols.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cargill

INDUSTRY

Sponsor Role: collaborator

Boston University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Naomi M Hamburg, MD

Role: PRINCIPAL_INVESTIGATOR

Boston University

Locations

Boston University School of Medicine

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

H-32353

Identifier Type: -

Identifier Source: org_study_id