The Effects of Dietary Erythritol on Platelet Reactivity and Vascular Inflammation

Официальное название

Randomized Controlled Clinical Trial to Gauge the Effects of Dietary Erythritol on Platelet Reactivity and Vascular Inflammation

Обзор

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

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• P-selectin, a platelet surface marker, assessed as median fluorescence intensity [Срок оценки: 6 weeks]
• P-selectin, a platelet surface marker, assessed as percentage of P-selectin positive cells [Срок оценки: 6 weeks]
• PAC-1 (GPIIb/IIIa complex), a platelet surface marker, assessed as median fluorescence intensity [Срок оценки: 6 weeks]
• PAC-1 (GPIIb/IIIa complex), a platelet surface marker, assessed as percentage of PAC-1 positive cells [Срок оценки: 6 weeks]
• Annexin V, a platelet surface marker, assessed as median fluorescence intensity [Срок оценки: 6 weeks]
• Annexin V, a platelet surface marker, assessed as percentage of annexin V positive cells [Срок оценки: 6 weeks]
• Platelet reactivity to physiologic agonist, assessed as change in median fluorescence intensity [Срок оценки: 6 weeks]
• Platelet aggregation in response to physiologic agonist, assessed as aggregation/min [Срок оценки: 6 weeks]
• Platelet aggregation in response to physiologic agonist, assessed as percent of maximum aggregation [Срок оценки: 6 weeks]
• Platelet-leukocyte interaction, assessed as platelet/leukocyte aggregate size by fluorescence mean intensity [Срок оценки: 6 weeks]

Вторичные конечные точки (9)

• Plasma concentration of E-Selectin [Срок оценки: 6 weeks]
• Plasma concentration of sVCAM1 [Срок оценки: 6 weeks]
• Plasma concentration of sICAM1 [Срок оценки: 6 weeks]
• Plasma concentration of D-dimer [Срок оценки: 6 weeks]
• Plasma concentration of Platelet factor 4 [Срок оценки: 6 weeks]
• Plasma concentration of Fibrinogen [Срок оценки: 6 weeks]
• Plasma concentration of Prothrombin fragment 1+2 [Срок оценки: 6 weeks]
• Plasma concentration of Plasmin-antiplasmin complex [Срок оценки: 6 weeks]
• Plasma concentration of Lp(a) [Срок оценки: 6 weeks]

Критерии участия

Критерии включения

• BMI ≥ 27 kg/m2

Критерии исключения

• • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Тройное слепое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• Ragle Human Nutrition Research Center, University of California, Davis — Davis

Публикации

• 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. PMID 36849732

Идентификаторы

NCT: NCT05967741 · 2030510

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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