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

NCT01908348 | Completed

• 1 other identifier: H-32353
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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

Keywords

Erythritol; Endothelial function

Outcome Measures

Primary Outcomes (1)

• Endothelial function

  Change in pulse amplitude in the fingertip in response to reactive hyperemia measured by peripheral arterial tonometry.

  2 hours

Study Arms (1)

Erythritol

EXPERIMENTAL

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

Dietary Supplement: Erythritol

Interventions

Erythritol DIETARY_SUPPLEMENT

Erythritol

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Women with a positive urine pregnancy test
• Body mass index \>35 kg/m2
• 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.

Sponsors & Collaborators

• Boston University: lead
• Cargill: collaborator

Study Sites (1)

Boston University School of Medicine

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Erythritol

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Study Officials

• Naomi M Hamburg, 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: SPONSOR

Study Record Dates

• First Submitted: July 23, 2013
• First Posted: July 25, 2013
• Study Start: July 18, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2016
• Last Updated: February 28, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)