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Идёт набор NCT06476795

The Influence of Chardonnay Marc Intake on Gut and Cardiometabolic Health

Без фазы С лечением Cardiovascular Diseases Adiposity Cardiometabolic Syndrome

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Chardonnay Marc.
Кому может быть актуально
Состояния в реестре: Cardiovascular Diseases, Adiposity, Cardiometabolic Syndrome. Базовые параметры: 45 лет — 70 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Recently a dietary recommendation of 400 - 600 mg/ day has been proposed for the reduced risk of developing cardiovascular disease. Dietary flavanols can be obtained from the intake of foods such as tea, cocoa, wine, berries and apples. Incorporating Chardonnay Marc (the skins and seeds of Chardonnay grapes) into the diet can be an additional source of dietary flavanols. Like other flavanol-rich foods, Chardonnay Marc provides fiber and polysaccharides that may benefit gut health. This study seeks pilot data on the impact of the daily incorporation of Chardonnay Marc powder into the diet on markers of gut and cardiometabolic health.

Подробное описание

The overall study objective is to obtain data on the impact of the dietary incorporation of Chardonnay marc on measures of gut and cardiometabolic health. Towards this goal, an escalation design will be employed to examine the effects of 6 - 12 weeks of daily Chardonnay marc intake on markers of gut permeability, inflammation and cardiometabolic health in obese individuals. Study procedures will be performed during 3 study visits conducted at baseline, and after 6 and 12 weeks of Chardonnay Marc intake. For each study visit, 50 ml of blood (\~3.5 tbsp) will be collected. For the first six weeks of the study, the participants will be asked to incorporate 1.5 g of Chardonnay Marc into their diet between the hours of 11 am and 4 pm every day. This level of intake will be increased to 4.5 g of Chardonnay marc everyday from weeks 6-12. Therefore, all individuals will consume Chardonnay marc for at least 12 weeks. The participants will be instructed to not cook or add the Chardonnay Marc to hot foods, however, they will be allowed to add the Marc to tepid or warm foods and beverages. They will also be asked to log their intake and how they incorporated the Marc into their diet via a log.

Вмешательства

  • Другое Chardonnay Marc
    Food product made from Chardonnay wine grapes

Первичные конечные точки

  • Microvascular function [Срок оценки: 12 weeks]
Вторичные конечные точки (10)
  • Plasma Cholesterol [Срок оценки: 12 weeks]
  • Cytokines [Срок оценки: 12 weeks]
  • short chain fatty acids [Срок оценки: 12 weeks]
  • plasma bile acids [Срок оценки: 12 weeks]
  • blood glucose [Срок оценки: 12 weeks]
  • Gene expression [Срок оценки: 12 weeks]
  • insulin [Срок оценки: 12 weeks]
  • zonulin [Срок оценки: 12 weeks]
  • lipopolysaccharide binding protein [Срок оценки: 12 weeks]
  • Metabolomics [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

  • Postmenopausal female, with a cessation of menses for at least 2 years
  • 45-70 years of age
  • BMI 25- 49.9 kg/m2
  • Fasting triglycerides > 120 mg/dL
  • Subject is willing and able to comply with the study protocols and procedures.

Критерии исключения

  • Self-reported use of daily anticoagulation agents including aspirin, NSAIDs
  • Prescription medications and supplements, except for a 6 month stable dose of thyroid medications
  • Vegan, Vegetarians, food faddists or those consuming a non-traditional diet
  • Fruit consumption ≥ 3 cups/day
  • Vegetable consumption ≥ 4 cups/day
  • Coffee/tea ≥ 3 cups/day
  • Dark chocolate ≥ 3 oz/day
  • Self-reported restriction of physical activity due to a chronic health condition
  • Self-reported chronic/routine high intensity exercise
  • Blood pressure ≥ 140/90 mm Hg
  • Self-reported renal or liver disease
  • Self-reported heart disease, which includes cardiovascular events and stroke, diabetes
  • Peripheral artery disease Raynaud's syndrome or disease
  • Inability to properly place or wear the PAT probes or abnormal measurements on pre-screening PAT
  • Self-reported cancer within past 5 years
  • Self-reported gastrointestinal disorders, apart from appendix removal
  • Unwillingness to stop any supplement use, including herbal, plant or botanical, fish oil, oil supplements six weeks prior to study enrollment.
  • Indications of substance or alcohol abuse within the last 3 years
  • All forms of smoking (e.g. vaping, cigarette, cannabis)
  • Current enrollee in a clinical research study.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Последовательный дизайн
Маскирование
Открытое
Основная цель
Другое

Центры проведения

США · 1 центр
  • University of California, Davis — Davis

Идентификаторы

NCT: NCT06476795 · 2034985

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗