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NCT Number: NCT05967741

The Effects of Dietary Erythritol on Platelet Reactivity and Vascular Inflammation

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

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Key information

Conditions

Platelet Aggregation, Spontaneous Cardiovascular Diseases Embolism and Thrombosis Thrombosis Vascular Diseases Vascular Thrombosis

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Erythritol

Other

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

Other names: Noncaloric sugar alcohol

aspartame

Other

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.

Other names: Noncaloric sweetener

Primary outcomes

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

    Time frame: 6 weeks

    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

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

    Time frame: 6 weeks

    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

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

    Time frame: 6 weeks

    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

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

    Time frame: 6 weeks

    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

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

    Time frame: 6 weeks

    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

  6. Annexin V, a platelet surface marker, assessed as percentage of annexin V positive cells

    Time frame: 6 weeks

    Change in percentage of annexin V 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

  7. Platelet reactivity to physiologic agonist, assessed as change in median fluorescence intensity

    Time frame: 6 weeks

    The change in median fluorescence intensity induced by physiologic agonists, an index of platelet reactivity, 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

  8. Platelet aggregation in response to physiologic agonist, assessed as aggregation/min

    Time frame: 6 weeks

    The change in aggregation/min induced by physiologic agonists will be measured by light transmission aggregometry 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

  9. Platelet aggregation in response to physiologic agonist, assessed as percent of maximum aggregation

    Time frame: 6 weeks

    The change in % maximum aggregation induced by physiologic agonists will be measured by light transmission aggregometry 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

  10. Platelet-leukocyte interaction, assessed as platelet/leukocyte aggregate size by fluorescence mean intensity

    Time frame: 6 weeks

    Change in platelet/leukocyte aggregate size, an index of platelet-leukocyte interaction, 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

Secondary outcomes

  1. Plasma concentration of E-Selectin

    Time frame: 6 weeks

    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

  2. Plasma concentration of sVCAM1

    Time frame: 6 weeks

    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

  3. Plasma concentration of sICAM1

    Time frame: 6 weeks

    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

  4. Plasma concentration of D-dimer

    Time frame: 6 weeks

    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

  5. Plasma concentration of Platelet factor 4

    Time frame: 6 weeks

    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

  6. Plasma concentration of Fibrinogen

    Time frame: 6 weeks

    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

  7. Plasma concentration of Prothrombin fragment 1+2

    Time frame: 6 weeks

    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

  8. Plasma concentration of Plasmin-antiplasmin complex

    Time frame: 6 weeks

    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

  9. Plasma concentration of Lp(a)

    Time frame: 6 weeks

    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

Other outcomes

  1. Plasma concentration of glucose

    Time frame: 6 weeks

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

  2. Plasma concentration of triglyceride

    Time frame: 6 weeks

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

  3. Plasma concentration of cholesterol

    Time frame: 6 weeks

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

  4. Plasma concentration of low density lipoprotein cholesterol

    Time frame: 6 weeks

    Change in plasma fasting low density lipoprotein cholesterol in subjects before and after sustained consumption of erythritol-sweetened beverage compared with change before and after sustained consumption of aspartame-sweetened beverage

  5. Plasma concentration of high density lipoprotein cholesterol

    Time frame: 6 weeks

    Change in plasma fasting high density lipoprotein cholesterol in subjects before and after sustained consumption of erythritol-sweetened beverage compared with change before and after sustained consumption of aspartame-sweetened beverage

  6. Plasma concentration of apolipoprotein B

    Time frame: 6 weeks

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

  7. Plasma concentration of apolipoprotein CIII

    Time frame: 6 weeks

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

  8. Plasma concentration of uric acid

    Time frame: 6 weeks

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

Study contacts

Contact information is provided by the study sponsor or research team.

Kimber L. Stanhope, Ph.D.

CONTACT

[email protected]

5302190914

Marinelle Nunez, B.S.

CONTACT

[email protected]

530-752-2146

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

Randomized Controlled Clinical Trial to Gauge the Effects of Dietary Erythritol on Platelet Reactivity and Vascular Inflammation

Acronym: EASI

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 1, 2023
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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