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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights
EASI Trial Summary
This trial tests how two different sweeteners affect people's health when consumed for 2 weeks each.
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.Check my eligibility
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.See study design
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.
EASI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreSecondary outcome measures
Plasma concentration of D-dimer
Plasma concentration of E-Selectin
Plasma concentration of Fibrinogen
+6 moreOther outcome measures
Plasma concentration of apolipoprotein B
Plasma concentration of apolipoprotein CIII
Plasma concentration of cholesterol
+5 moreEASI 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.
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Who is running the clinical trial?
University of California, DavisLead Sponsor
911 Previous Clinical Trials
4,709,495 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am taking or might take medication for high cholesterol, high blood pressure, or diabetes.You do very intense exercise for more than 4 hours a week.I have a history of heart or blood vessel problems, or I currently have cancer.Your body mass index (BMI) is 27 or higher.You smoke or use tobacco products.I have had surgery or taken medication to lose weight.
Research Study Groups:
This trial has the following groups:- Group 1: Erythritol-sweetened beverage
- Group 2: Aspartame-sweetened beverage
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research project encompass individuals below the age of twenty-five?
"This experimental trial is open to applicants that are aged 18 or above and below 70 years old."
Answered by AI
What are the expected results of this experiment?
"This 6 week long trial will measure the percentage of P-selectin positive cells, a platelet surface marker. Secondary objectives include analyzing changes in sVCAM1, sICAM1 and D-dimer plasma concentrations before and after sustained consumption of either erythritol or aspartame sweetened beverages."
Answered by AI
Are new participants accepted in this research endeavor?
"According to the information posted on clinicaltrials.gov, this study is not currently recruiting any new patients. The trial was first advertised back in July 20th of last year and its most recent update came a day later. Nonetheless, there are still 500 other medical studies that are actively accepting patient enrolment at this moment in time."
Answered by AI
For whom is this trial open to participation?
"The requirements for this trial are that potential participants must have a blood clot and be between 18 - 70 years old. Altogether, 24 individuals will ultimately take part in the project."
Answered by AI
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