The Effects of Dietary Erythritol on Platelet Reactivity and Vascular Inflammation

NCT ID: NCT05967741

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-20
• Study Completion Date: 2026-06-30

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

Detailed Description

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.

Conditions

Platelet Aggregation, Spontaneous; Vascular Thrombosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Erythritol-sweetened beverage

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

Group Type: EXPERIMENTAL

Erythritol

Intervention Type: OTHER

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

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.

Group Type: PLACEBO_COMPARATOR

Aspartame

Intervention Type: 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.

Interventions

Erythritol

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

Intervention Type: OTHER

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.

Intervention Type: OTHER

Other Intervention Names

Noncaloric sugar alcohol; Noncaloric sweetener

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ragle Human Nutrition Research Center, University of California, Davis

Davis, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kimber L. Stanhope, Ph.D.

Role: CONTACT

klstanhope@ucdavis.edu

5302190914

Marinelle Nunez, B.S.

Role: CONTACT

mvnunez@ucdavis.edu

530-752-2146

Facility Contacts

Kimber Stanhope, Ph.D.

Role: primary

klstanhope@ucdavis.edu

530-752-3720

Marinelle Nunez, B.S.

Role: backup

mvnunez@ucdavis.edu

530-752-2146

References

Witkowski M, Nemet I, Alamri H, Wilcox J, Gupta N, Nimer N, Haghikia A, Li XS, Wu Y, Saha PP, Demuth I, Konig M, Steinhagen-Thiessen E, Cajka T, Fiehn O, Landmesser U, Tang WHW, Hazen SL. The artificial sweetener erythritol and cardiovascular event risk. Nat Med. 2023 Mar;29(3):710-718. doi: 10.1038/s41591-023-02223-9. Epub 2023 Feb 27.

Reference Type: BACKGROUND

PMID: 36849732 (View on PubMed)

Other Identifiers

2030510

Identifier Type: -

Identifier Source: org_study_id