Идёт набор NCT06965699

The Effect of a Plant-based, Protein-dense Sauce on Essential Amino Acid Concentrations and Gut Fullness in Older Adults

Без фазы С лечением Malnutrition Elderly Protein Malnutrition

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: ProSauce, low-protein sauce.
Кому может быть актуально: Состояния в реестре: Malnutrition Elderly, Protein Malnutrition. Базовые параметры: от 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: Великобритания
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Testing the Effect of a Plant-based, Protein-dense Sauce (ProSauce) on Metabolic Availability of Essential Amino Acids and Gut Fullness and Satiety in Older Adults

Обзор

The goal of this clinical trial is to determine whether meals fortified with plant-based high protein sauce (ProSauce) provide better metabolic availability of essential amino acids compared to meals with standard lower-protein sauce without resulting in excessive gut fullness and satiety. The main questions it aims to answer are: Does meals with high-protein sauce deliver better metabolic availability of amino acid profile? Does this high-protein sauce also not lead to excessive appetite suppression due to its liquid form? Researchers will compare high protein sauce to a commercially available standard low protein sauce. Participants will consume two meals, either protein-fortified or standard low-protein sauce, in a randomised order with at least a one-week washout period between each meal. The investigators will collect venous blood samples over a 6-hour postprandial period to measure plasma essential (and non-essential) amino acid and insulin concentrations. The investigators will also measure appetite-related hormones from venous plasma and assess subjective appetite using a visual analogue scale, taken in parallel with the blood sample time points.

Вмешательства

Пищевая добавка ProSauce
10g additional protein from ProSauce
Пищевая добавка low-protein sauce
Commercially available standard low-protein sauce

Первичные конечные точки

Concentrations of essential amino acids [Срок оценки: Essential amino acid concentrations at time points of baseline, immediately after breakfast (t =0 minute) and t = 20, 40, 60, 90, 120, 180, 240, 300, 360 minutes.]

Вторичные конечные точки (1)

Concentrations of appetite-related gut hormones [Срок оценки: Appetite-related gut hormones will be measured at time points of baseline, immediately after breakfast (t =0 minute) and t = 20, 40, 60, 90, 120, 150, 180, 210, 240 minutes.]

Критерии участия

Критерии включения

Aged 60 and over
Living independently in the community
Capacity to provide informed consent
Non-smoking (vaping is considered smoking)
No known medical conditions that might influence the study outcomes, e.g., heart disease, diabetes mellitus, obesity, disthyroidism and other endocrinopathies and renal failure
Not taking any medications that might influence the study outcomes e.g., taking anabolic steroids or corticosteroids long term
No clinically diagnosed eating disorders
No severe dislike or allergy to any of the study food
No hospitalisations in the last 6 months
Not dieting and weight stable for 3 months before the study (< 3 kg change in weight)