Recruiting

Erythritol

Sponsor:

UCLA

Code:

NCT05967741

Conditions

Platelet Aggregation, Spontaneous

Vascular Thrombosis

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Interventions

Erythritol

Aspartame

Study Details

Brief summary:

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

Conditions

Platelet Aggregation, Spontaneous

Vascular Thrombosis

Study ID

NCT05967741

Start date

Jul 20, 2023

Status verified date

Dec, 2025

Completion date

Jun, 2026

Anticipated

Primary completion date

May 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Erythritol-sweetened beverage

1-gram erythritol/kg body weight/day, divided into three beverage servings and fruit-flavored with Kool-Aid® unsweetened drink mix.

placebo comparator: Aspartame-sweetened beverage

Control beverages will be made from a noncaloric aspartame-sweetened, fruit-flavored drink mix at the concentration needed to match the sweetness (\~3 mg aspartame/kg/day) and flavoring of the erythritol beverages on a per volume basis.

Interventions

Erythritol

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

Aspartame

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.

Primary outcome measure

  • P-selectin, a platelet surface marker, assessed as median fluorescence intensity [ Time Frame: 6 weeks ]
  • P-selectin, a platelet surface marker, assessed as percentage of P-selectin positive cells [ Time Frame: 6 weeks ]
  • PAC-1 (GPIIb/IIIa complex), a platelet surface marker, assessed as median fluorescence intensity [ Time Frame: 6 weeks ]
  • PAC-1 (GPIIb/IIIa complex), a platelet surface marker, assessed as percentage of PAC-1 positive cells [ Time Frame: 6 weeks ]
  • Annexin V, a platelet surface marker, assessed as median fluorescence intensity [ Time Frame: 6 weeks ]
  • Annexin V, a platelet surface marker, assessed as percentage of annexin V positive cells [ Time Frame: 6 weeks ]
  • Platelet reactivity to physiologic agonist, assessed as change in median fluorescence intensity [ Time Frame: 6 weeks ]
  • Platelet aggregation in response to physiologic agonist, assessed as aggregation/min [ Time Frame: 6 weeks ]
  • Platelet aggregation in response to physiologic agonist, assessed as percent of maximum aggregation [ Time Frame: 6 weeks ]
  • Platelet-leukocyte interaction, assessed as platelet/leukocyte aggregate size by fluorescence mean intensity [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Kimber L. Stanhope, Ph.D.

5302190914klstanhope@ucdavis.edu

Marinelle Nunez, B.S.

530-752-2146mvnunez@ucdavis.edu

Locations

Ragle Human Nutrition Research Center, University of California, Davis

Recruiting

Davis, California, United States, 95616

Contacts

Kimber Stanhope, Ph.D.

530-752-3720klstanhope@ucdavis.edu

Marinelle Nunez, B.S.

530-752-2146mvnunez@ucdavis.edu

More Information

Sponsor

University of California, Davis

Last update posted

Dec 5, 2025

Last verified

Dec, 2025

Keywords

  • platelet activation
  • vascular inflammation
  • erythritol
  • aspartame
  • dietary intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Davis on 2025-12-05.