The Effects of Dietary Erythritol on Platelet Reactivity and Vascular Inflammation

University of California, Davis24 enrolled

Overview

The purpose is to conduct a dietary intervention study in which human participants will consume beverages sweetened with erythritol or aspartame, each for 2 weeks, in a randomized crossover design

There is a strong correlation between plasma erythritol concentrations and adverse cardiovascular events in high risk individuals. It has also been demonstrated that consumption of dietary erythritol leads to high levels of plasma erythritol. There is in vitro evidence that erythritol at comparable concentrations promotes platelet activation. However, there is no direct evidence that links human consumption of erythritol with the onset of platelet activation and adhesion leading to inflammation. The investigators seek to fill this evidence gap by conducting a randomized crossover dietary intervention study in which human participants will consume beverages sweetened with erythritol or aspartame, each for two weeks.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Platelet Aggregation, Spontaneous Vascular Thrombosis

Interventions

ErythritolOTHER

Erythritol is a naturally occurring and non-nutritive sugar alcohol that is classified as generally recognized as safe (GRAS)

AspartameOTHER

Aspartame consists of two amino acids, phenylalanine and aspartic acid, and a methyl group. It does not have metabolic effects and has served as the blinded control beverage in the investigators' completed NIH-funded clinical trials.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * BMI ≥ 27 kg/m2 Exclusion Criteria: * • History of blood clot, transient ischemic attack (TIA), stroke, angina, heart attack, or peripheral vascular disease, or current cancer diagnosis. * Pregnant or lactating women * Current, prior (within 12 months), or anticipated use of medications for treatment of hyperlipidemia, high blood pressure or diabetes, or any medication that in the opinion of the investigators will confound results. * Unwilling to forego the use of anti-inflammatory medication during study. * Unwilling to forego the use of marijuana during the study. * Use of tobacco. * Strenuous exerciser (\>4 hours/week at a level more vigorous than walking). * Surgery or medication for weight loss. * Diet exclusions: Food allergies or dietary restrictions that may undermine compliance to dietary protocol, routine ingestion of more than 2 sugar-sweetened beverages or 2 alcoholic beverage/day. Unwillingness to consume artificial or noncaloric sweeteners. Habitual consumption (\>10 gram/day) of beverage or foods that contain erythritol. Recent or current weight loss diet.

Locations (1)

Ragle Human Nutrition Research Center, University of California, Davis

Davis, California, United States

RECRUITING

Outcomes

Primary Outcomes

P-selectin, a platelet surface marker, assessed as median fluorescence intensity

Change in median fluorescence intensity of P-selectin, an index of platelet activation, will be measured by flow cytometry in whole blood collected from subjects before and after consuming erythritol-sweetened beverage for 2 weeks and compared with change in whole blood collected before and after consuming aspartame-sweetened beverage for 2 weeks

Time frame: 6 weeks

P-selectin, a platelet surface marker, assessed as percentage of P-selectin positive cells

Change in percentage of P-selectin positive cells, an index of platelet activation, will be measured by flow cytometry in whole blood collected from subjects before and after consuming erythritol-sweetened beverage for 2 weeks and compared with change in whole blood collected before and after consuming aspartame-sweetened beverage for 2 weeks

Time frame: 6 weeks

PAC-1 (GPIIb/IIIa complex), a platelet surface marker, assessed as median fluorescence intensity

Change in median fluorescence intensity of PAC-1, an index of platelet activation, will be measured by flow cytometry in whole blood collected from subjects before and after consuming erythritol-sweetened beverage for 2 weeks and compared with change in whole blood collected before and after consuming aspartame-sweetened beverage for 2 weeks

Time frame: 6 weeks

PAC-1 (GPIIb/IIIa complex), a platelet surface marker, assessed as percentage of PAC-1 positive cells

Change in percentage of PAC-1 positive cells, an index of platelet activation, will be measured by flow cytometry in whole blood collected from subjects before and after consuming erythritol-sweetened beverage for 2 weeks and compared with change in whole blood collected before and after consuming aspartame-sweetened beverage for 2 weeks

Time frame: 6 weeks

Annexin V, a platelet surface marker, assessed as median fluorescence intensity

Change in median fluorescence intensity of annexin V, an index of platelet activation, will be measured by flow cytometry in whole blood collected from subjects before and after consuming erythritol-sweetened beverage for 2 weeks and compared with change in whole blood collected before and after consuming aspartame-sweetened beverage for 2 weeks

Central Contacts

Kimber L. Stanhope, Ph.D.

CONTACT

5302190914 klstanhope@ucdavis.edu

Marinelle Nunez, B.S.

CONTACT

530-752-2146 mvnunez@ucdavis.edu

Data from ClinicalTrials.gov

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Secondary Outcomes

Plasma concentration of E-Selectin

Change in plasma E-Selectin in subjects before and after sustained consumption of erythritol-sweetened beverage compared with change before and after sustained consumption of aspartame-sweetened beverage

Time frame: 6 weeks

Plasma concentration of sVCAM1

Change in plasma sVCAM1 in subjects before and after sustained consumption of erythritol-sweetened beverage compared with change before and after sustained consumption of aspartame-sweetened beverage

Time frame: 6 weeks

Plasma concentration of sICAM1

Change in plasma sICAM1 in subjects before and after sustained consumption of erythritol-sweetened beverage compared with change before and after sustained consumption of aspartame-sweetened beverage

Time frame: 6 weeks

Plasma concentration of D-dimer

Change in plasma D-dimer in subjects before and after sustained consumption of erythritol-sweetened beverage compared with change before and after sustained consumption of aspartame-sweetened beverage

Time frame: 6 weeks

Plasma concentration of Platelet factor 4

Change in plasma platelet factor 4 in subjects before and after sustained consumption of erythritol-sweetened beverage compared with change before and after sustained consumption of aspartame-sweetened beverage

Time frame: 6 weeks

Plasma concentration of Fibrinogen

Change in plasma fibrinogen in subjects before and after sustained consumption of erythritol-sweetened beverage compared with change before and after sustained consumption of aspartame-sweetened beverage

Time frame: 6 weeks

Plasma concentration of Prothrombin fragment 1+2

Change in plasma prothrombin fragment 1+2 in subjects before and after sustained consumption of erythritol-sweetened beverage compared with change before and after sustained consumption of aspartame-sweetened beverage

Time frame: 6 weeks

Plasma concentration of Plasmin-antiplasmin complex

Change in plasma plasmin-antiplasmin complex in subjects before and after sustained consumption of erythritol-sweetened beverage compared with change before and after sustained consumption of aspartame-sweetened beverage

Time frame: 6 weeks

Plasma concentration of Lp(a)

Change in plasma Lp(a) in subjects before and after sustained consumption of erythritol-sweetened beverage compared with change before and after sustained consumption of aspartame-sweetened beverage

Time frame: 6 weeks