Effects of Erythritol on Blood Platelets and Inflammation
Randomized Controlled Clinical Trial to Gauge the Effects of Dietary Erythritol on Platelet Reactivity and Vascular Inflammation
This study tests whether drinking beverages sweetened with erythritol affects blood platelets and inflammation in people compared to those sweetened with aspartame.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University of California, Davis Academic / other |
| Locations | 1 site (Davis, California) |
| Trial ID | NCT05967741 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of dietary erythritol on platelet reactivity and vascular inflammation through a randomized crossover design. Participants will consume beverages sweetened with either erythritol or aspartame for two weeks each. The study aims to establish a direct link between erythritol consumption and platelet activation, addressing a gap in current cardiovascular research. By comparing the effects of these two sweeteners, the researchers hope to provide insights into dietary influences on cardiovascular health.
Who should consider this trial
Good fit: Ideal candidates are individuals with a BMI of 27 kg/m2 or higher who do not have a history of significant cardiovascular issues.
Not a fit: Patients with a history of blood clots, strokes, or other serious cardiovascular conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable information on the safety of erythritol consumption for individuals at risk of cardiovascular events.
How similar studies have performed: While there is existing evidence linking erythritol to platelet activation in vitro, this study represents a novel approach to directly assess its effects in humans.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Davis, California
- Ragle Human Nutrition Research Center, University of California, Davis — Davis, California, United States (Recruiting)
Study contacts
- Study coordinator: Kimber L. Stanhope, Ph.D.
- Email: klstanhope@ucdavis.edu
- Phone: 5302190914
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.