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Набор скоро начнётся NCT06758869

Pulse Revolution: Enhancing Metabolic Health Through the Power of Processed Chickpeas

Без фазы С лечением Healthy

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: Control, Whole Chickpeas, Puréed Chickpeas, 100% Chickpea Flour Product.
Кому может быть актуально
Состояния в реестре: Healthy. Базовые параметры: 19 лет — 60 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

Effects of Daily Consumption of Processed Pulse-based Food Products on Physiological Responses Related to Energy Metabolism and Metabolic Health

Обзор

The purpose of this research is to test how processing can affect how one's body uses the nutrients in that food. For this study the researchers are examining how making different food products out of chickpeas, such as hummus or pasta, changes how one's body uses those foods for energy.

Подробное описание

The overall objective is to determine the impact of daily consumption of processed pulse-based food products on metabolic health, specifically the physiological responses related to energy metabolism. The primary hypothesis is that consuming a serving of pulses daily for 12 weeks will improve metabolic responses related to energy metabolism, particularly fat oxidation and molecular adaptations related to fat and glucose metabolism, compared to current Dietary Guidelines for Americans (DGA) recommendations. Furthermore, we hypothesize that the degree of processing will influence these metabolic adaptations such that the daily consumption of 100% pulse flour food products will result in the greatest effect on fat oxidation and molecular adaptations related to fat and glucose metabolism followed by the pulse purée which will have a greater effect than the whole cooked pulse (100% pulse flour \> purée \> whole).

Вмешательства

  • Другое Control
    Participants will consume the Base DGA diet with a standardized non-pulse product snack.
  • Другое Whole Chickpeas
    Participants will consume an adjusted DGA diet with a standardized whole chickpea snack.
  • Другое Puréed Chickpeas
    Participants will consume an adjusted DGA diet with a standardized puréed chickpea snack.
  • Другое 100% Chickpea Flour Product
    Participants will consume an adjusted DGA diet with a standardized 100% chickpea flour product snack.

Первичные конечные точки

  • Differences in substrate oxidation in response to eating differentially processed pulse-based food products [Срок оценки: 12 weels]
  • Change from Baseline in substrate oxidation after consuming differentially processed pulse-based food products for 12 weeks [Срок оценки: 12 weeks]
  • Determine participant consumption practices and attitudes towards pulse consumption using a validated questionnaire [Срок оценки: Baseline]
Вторичные конечные точки (2)
  • Changes in the colonic microbiota in response to consuming differentially processed pulse-based food products [Срок оценки: 12 weeks]
  • Changes in me metabolic gene expression and metabolites in response to consuming differentially processed pulse-based food products. [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

  • apparently healthy adults
  • BMI >18.5 or <35 kg/m2 (healthy body weight - class I obesity)
  • ability to understand and sign the consent form
  • availability of transportation (i.e., participants must provide their own transportation to the Center)
  • non-smoking or do not use other tobacco products, including e-cigarettes
  • not taking steroid-based medications
  • not planning to or currently attempting to gain or lose weight
  • not allergic to study foods
  • willing to comply with study demands

Критерии исключения

  • usual pulse consumption greater than DGA recommendation
  • inability or unwillingness to consume any of the provided foods
  • more than a 10% change in body weight within the past 2 months
  • actively trying to lose weight
  • pregnancy or actively trying to get pregnant
  • lactation
  • uncontrolled hypertension (systolic >160 mmHg or diastolic >100 mmHg)
  • diagnosed cardiovascular, pulmonary, skeletal and metabolic diseases
  • HbA1c ≥ 5.7%
  • complete blood count (CBC) outside of the normal range for a healthy adult
  • history of gastrointestinal (GI) disorders (including Celiac's or Crohn's disease, irritable bowel syndrome, acid reflux, ulcerative colitis, chronic constipation or diarrhea, and lactose intolerance)
  • using medications known to affect appetite, blood lipids, body composition, body weight, or food intake (appetite control drugs, steroids)
  • cannot read or understand English

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Другое

Центры проведения

США · 1 центр
  • USDA Grand Forks Human Nutrition Research Center — Grand Forks

Идентификаторы

NCT: NCT06758869 · GFHNRC514

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗