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Идёт набор NCT06867198

Peanuts for Cardiometabolic, Brain, and Intestinal Health

Без фазы С лечением Prediabetes Prediabetes (Insulin Resistance, Impaired Glucose Tolerance) Cognition Microvascular Function

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: Peanuts.
Кому может быть актуально
Состояния в реестре: Prediabetes, Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Cognition, Microvascular Function. Базовые параметры: 20 лет — 59 лет · Все.
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 →
Официальное название

Impact of Peanuts on Cardiometabolic, Cognitive, and Intestinal Health in Prediabetes Among Racially Diverse Populations

Обзор

The overall objective of this 14-month randomized crossover study is to seek evidence demonstrating that daily consumption of peanuts and peanut products improve cardiometabolic, cognitive, and intestinal health in a racially diverse prediabetes population.

Подробное описание

In the US, 37.1 million adults have diabetes mellitus and 96 million have prediabetes. Type 2 diabetes mellitus (T2DM) accounts for 95% of the cases and results in many public health complications that increase economic burden and reduce productivity and quality of life. Eight out of 10 people with T2DM die from cardiovascular disease, while those with T2DM also face a 50% higher risk of developing dementia compared to healthy individuals. Also, studies indicate that intestinal health significantly influences the development of T2DM. Of note, the burden of T2DM is particularly pronounced in non-Hispanic Black and Hispanic populations compared to the non-Hispanic White population. Prevention and treatment of T2DM focus on lifestyle changes including dietary modifications. Plant-based foods, including peanuts and peanut products, have been increasingly recognized for their importance in the prevention and management of prediabetes and T2DM due to their unique nutritional profile, including their favorable fatty acid composition, fiber content, and bioactive compounds. While emerging evidence indicates that peanut improves cardiometabolic, cognitive and intestinal health, no studies have collectively and comprehensively evaluated the effects of peanut or peanut product consumption on the cardiometabolic, cognitive, and intestinal health of individuals with prediabetes or T2DM. Thus, this study aims to investigate whether adults with prediabetes consuming 43 g of peanut butter (1 snack cup) 3 x/week, 42 g of dry roasted peanuts (1/3 of a cup) 3x/week, or 56 g of peanut flour 1x/week for six months will have 1) reduced levels of serum HbA1c, fasting glucose (FBG), insulin, HOMA-IR (homeostatic model assessment of insulin resistance) and improved lipid profile, 2) reduced blood pressure, improved endothelial function, arterial stiffness and microvascular function, 3) Improved gut microbiota composition and reduced intestinal permeability, 4) improved cognitive function (verbal memory and executive functions \[inhibition, working memory, cognitive flexibility\]) and brain health metrics as assessed by neuroimaging, and 5) reduced serum markers of oxidative stress and inflammation. The effectiveness of the intervention on the abovementioned outcomes among races including non-Hispanic Black (NHBA), non-Hispanic White (NHWA), non-Hispanic Asian (NHAA) and Hispanic (HA) adults will also be compared. Lastly, whether changes in cardiometabolic and cognitive outcomes are associated with changes in intestinal microbiota outcomes and whether changes in cardiometabolic outcomes are associated with changes in cognitive function parameters will be explored.

Вмешательства

  • Пищевая добавка Peanuts
    43 g of peanut butter (1 snack cup) 3 x/week, 42 g of dry roasted peanuts (1/3 of a cup) 3x/week, or 56 g of peanut flour 1x/week for 6 months.

Первичные конечные точки

  • Blood Glucose [Срок оценки: Baseline, 3 months, and 6 months]
  • Glycosylated hemoglobin [Срок оценки: Baseline, 3 months, and 6 months]
Вторичные конечные точки (12)
  • Ambulatory Blood Pressure [Срок оценки: Baseline, 3 months, and 6 months]
  • Fasting Insulin [Срок оценки: Baseline, 3 months, and 6 months]
  • Homeostasis model assessment-insulin resistance (HOMA-R) [Срок оценки: Baseline, 3 months, and 6 months]
  • Blood Lipid Profile [Срок оценки: Baseline, 3 months, and 6 months]
  • Gut Microbiota Composition [Срок оценки: Baseline, 3 months, and 6 months]
  • Global Cognitive Ability [Срок оценки: Baseline, 3 months, and 6 months]
  • Performance Validity [Срок оценки: Baseline, 3 months, and 6 months]
  • Verbal Memory & Recognition [Срок оценки: Baseline, 3 months, and 6 months]
  • Cognitive Inhibition [Срок оценки: Baseline, 3 months, and 6 months]
  • Cognitive Flexibility [Срок оценки: Baseline, 3 months, and 6 months]
  • Working Memory [Срок оценки: Baseline, 3 months, and 6 months]
  • Processing Speed [Срок оценки: Baseline, 3 months, and 6 months]

Критерии участия

Критерии включения

  • men and women
  • 20-59 years of age
  • BMI: 24.5 - 35.5 kg/m\^2
  • Prediabetes (fasting blood glucose levels 100-125 mg/dL and/or HbA1c between 5.7-6.4%)
  • Ability to give consent

Критерии исключения

  • Allergies to peanuts and peanut products
  • Use of insulin, antidiabetic, antibiotics, and anti-inflammatory drugs
  • Active cancer, gastrointestinal, renal, cardiovascular, thyroid, and neurological diseases or severe head injury
  • Smoking
  • Consumes greater than 2 alcoholic beverages per day
  • Consumes antioxidant, probiotic, and prebiotic supplements
  • Pregnant or Lactating
  • Actively participating in a weight loss program

MRI Exclusion Criteria:

  • Certain neurological disorders (e.g., uncontrolled seizure disorders)
  • Braces on their teeth, a cardiac pacemaker; hearing aid; other metal in the body or eyes (which may include certain metallic-embedded tattoos), including but not limited to pins, screws, shrapnel, plates, dentures or other metal objects

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Простое слепое
Основная цель
Фундаментальное исследование

Центры проведения

США · 1 центр
  • Georgia State University — Atlanta

Идентификаторы

NCT: NCT06867198 · H25014

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗