What side effects are associated with this type of intervention?

Common treatments for blood clots include anticoagulants such as warfarin, heparin, rivaroxaban, and apixaban. Known side effects of these medications can include bleeding complications, such as gastrointestinal bleeding or intracranial hemorrhage, and other issues like bruising, anemia, and thrombocytopenia. Warfarin specifically requires regular blood monitoring due to its narrow therapeutic range and potential interactions with food and other medications. Newer agents like rivaroxaban and apixaban generally have fewer dietary restrictions but still carry a risk of bleeding.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of blood clots, including anticoagulants like warfarin, heparin, and low-molecular-weight heparins (e.g., enoxaparin). Direct oral anticoagulants (DOACs) such as apixaban, rivaroxaban, and dabigatran have also been approved for preventing and treating thromboembolic events. These medications work by inhibiting various factors in the coagulation cascade to prevent clot formation. While erythritol and aspartame are sweeteners and not directly related to these treatments, understanding their metabolic effects could be relevant for patients with metabolic conditions that may influence clotting risks.

What other types of research exist?

Promising novel alternatives to erythritol and aspartame for blood clot patients include stevia and monk fruit extract. Both are natural sweeteners that have minimal impact on blood glucose levels and do not appear to increase thrombotic risks. Additionally, allulose is another emerging sweetener that has shown potential for minimal glycemic impact and may be suitable for patients concerned with blood clotting issues.

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Erythritol for Blood Clot Prevention and Inflammation (EASI Trial)

N/A

Recruiting

Research Sponsored by University of California, Davis

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

History of blood clot, transient ischemic attack (TIA), stroke, angina, heart attack, or peripheral vascular disease, or current cancer diagnosis

Surgery or medication for weight loss

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Summary

This trial involves participants drinking beverages sweetened with either erythritol or aspartame for a short period. The study focuses on people at high risk for heart problems. Researchers aim to see if erythritol causes changes in the blood that could lead to heart issues, compared to aspartame. Aspartame is a commonly used intense artificial sweetener, being approximately 200 times sweeter than sucrose. There have been concerns over aspartame since approval in the 1980s including a large anecdotal database reporting severe symptoms.

Who is the study for?

This trial is for adults with a BMI of 27 kg/m2 or higher who don't exercise strenuously, aren't pregnant or lactating, and have no major dietary restrictions. It's not for those who drink lots of sugar or alcohol, use certain medications, have had serious cardiovascular issues, are on weight loss drugs or diets, consume erythritol regularly, use anti-inflammatory drugs or marijuana, smoke tobacco, or have had recent surgery.

What is being tested?

The study tests the effects of drinks sweetened with erythritol versus aspartame on blood clotting and inflammation. Participants will try each sweetener in their beverages for two weeks in a random order to see how it affects their body.

What are the potential side effects?

While the side effects are not specified here, artificial sweeteners like aspartame and erythritol can sometimes cause digestive discomfort such as bloating and gas in some individuals.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a history of heart or blood vessel problems, or I currently have cancer.

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I have had surgery or taken medication to lose weight.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

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

+7 more

Secondary study objectives

Plasma concentration of D-dimer

Plasma concentration of E-Selectin

Plasma concentration of Fibrinogen

+6 more

Other study objectives

Plasma concentration of apolipoprotein B

Plasma concentration of apolipoprotein CIII

Plasma concentration of cholesterol

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Erythritol-sweetened beverageExperimental Treatment1 Intervention

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

Group II: Aspartame-sweetened beveragePlacebo Group1 Intervention

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.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for blood clots include antiplatelet agents like aspirin and anticoagulants such as warfarin and heparin. Antiplatelet agents work by inhibiting platelet aggregation, preventing the formation of clots. Anticoagulants interfere with the clotting cascade, reducing the blood's ability to form clots. These treatments are crucial for blood clot patients as they help prevent the progression of clots, which can lead to serious conditions like stroke or myocardial infarction. Sweeteners like erythritol and aspartame, while primarily used to manage metabolic and glycemic responses, could potentially influence platelet reactivity and vascular inflammation, thus indirectly affecting clot formation and stability.

Effect of low cholesterol, linoleic acid enriched diet on thrombotic tendency and plasma lipoproteins in patients with angina pectoris.The effect of hydroxyethyl starch 200 kD on platelet function.