The Effects of Dietary Erythritol on Platelet Reactivity and Vascular Inflammation

Conditions

• Platelet Aggregation, Spontaneous
• Vascular Thrombosis

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Accepted

Interventions

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

Study Details

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

Key Dates

Start date

Jul 20, 2023

Status verified

Dec 2025

Primary completion

May 31, 2026

Completion

Jun 30, 2026

Study Design

Enrollment

24 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

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.

Primary Outcome Measure

P-selectin, a platelet surface marker, assessed as median fluorescence intensity [ Time Frame: 6 weeks ]

Central Contacts

• Kimber L. Stanhope, Ph.D.
  5302190914
  [email protected]
• Marinelle Nunez, B.S.
  530-752-2146
  [email protected]

Locations (1)

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