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The Effects of Dietary Erythritol on Platelet Reactivity and Vascular Inflammation

ConditionsPlatelet Aggregation, SpontaneousVascular Thrombosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of California, Davis

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

BMI ≥ 27 kg/m2

Disqualifiers

• 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.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Erythritol

    Other intervention

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

  • Aspartame

    Other intervention

    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.

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Erythritol-sweetened beverageExperimental treatment 1 intervention
Group B: Aspartame-sweetened beveragePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

1

Plasma concentration of glucose

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

Time frame
6 weeks
2

Plasma concentration of triglyceride

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

Time frame
6 weeks
3

Plasma concentration of cholesterol

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

Time frame
6 weeks
4

Plasma concentration of low density lipoprotein cholesterol

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

Time frame
6 weeks

Sponsors and contacts

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University of California, Davis

Lead sponsor

Source ClinicalTrials.gov
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