Меню
Набор скоро начнётся NCT07561619

Yeast Protein for Muscle Mass

Фаза II / Фаза III С лечением Healthy Adult Participants

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: Yeast Protein, Resistance Training Exercises, Whey Protein.
Кому может быть актуально
Состояния в реестре: Healthy Adult Participants. Базовые параметры: 18 лет — 35 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
Канада
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Yeast Protein for Muscle Anabolism: A Randomized Controlled Trial

Обзор

Protein supplementation is said to be one of the cost-efficient and practical strategies to meet protein needs for growth and exercise, and can help maximize muscle gain from resistance exercise. It facilitates faster recovery from stress-induced tissue damage and enhances performance output. Protein sources derived from animal products are generally recognized as the highest quality protein. However, altering the protein composition of a protein source can improve the protein quality. The yeast protein supplement the investigators will use in this study has a similar amino acid composition to whey protein, which is derived from an animal product, but it is produced more sustainably. The study aims to compare the effects of yeast and whey protein on muscle mass over 16 weeks.

Подробное описание

This is a double-blinded randomized clinical trial of a 16-week nutrition intervention with yeast and whey protein in 72 people (36 per group; 18 male and 18 female) between the ages of 18 and 35, recruited from the University of Alberta campus, Edmonton, Canada. Consenting participants will be randomly assigned to one of two groups: whey protein or yeast protein by the study coordinator, who will not collect study outcome measurements or analyze the data.

The goal of the trial is to determine if consumption of 40 g per day of yeast protein produces similar effects to 40 g supplementation with whey protein. It is anticipated that daily yeast protein consumption will show similar gains in muscle mass and improvement in immune function, increased diversity in gut microbiota, and amino acid-derived metabolites compared to whey protein.

Вмешательства

  • Пищевая добавка Yeast Protein
    60g of protein supplement (40g of protein). Oral administration, 30g during exercise and anytime after exercise, or 30g in the morning and evening if no exercise is performed for a period of 16 weeks.
  • Другое Resistance Training Exercises
    Lower and upper body resistance training exercises 3 times a week for 16 weeks
  • Пищевая добавка Whey Protein
    60g of protein supplement (40g of protein). Oral administration, 30g during exercise and anytime after exercise, or 30g in the morning and evening if no exercise is performed for a period of 16 weeks.

Первичные конечные точки

  • Changes in muscle mass [Срок оценки: 16 weeks]
Вторичные конечные точки (1)
  • Changes in muscle function, inflammatory biomarkers, oxidative stress markers, gut microbiota and metabolites [Срок оценки: 16 weeks]

Критерии участия

Критерии включения

  • Participants must have the ability to read, understand, and sign an informed consent and must be willing to comply with study treatment and follow-up.
  • Prior resistance training experience (defined as performing resistance exercises >1/week for the past 3 months or longer) to enable them to reach a large training stimulus relatively quickly and to avoid the longer phase of neuromuscular adaptations
  • ≥18 years and <35 years of age

Критерии исключения

  • Diabetes, musculoskeletal disease, cancer, Crohn's disease, or any other acute or chronic condition that interferes (or the medication prescribed for those conditions) with muscle anabolism.
  • Diagnosed with or being treated for heart disease, stroke, high blood pressure 130/80 mmHg or higher
  • Pain/discomfort/pressure in the chest during activities of daily living or physical activity
  • Pregnant or not on adequate contraception.
  • A known hypersensitivity/allergy to ingredients in the supplements.
  • Inflammatory bowel diseases
  • Enrolment in any other clinical protocol or investigational study that may interfere with study procedures
  • Taking antibiotics

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
Тройное слепое
Основная цель
Фундаментальное исследование

Центры проведения

Канада · 1 центр
  • The University of Alberta North Campus — Edmonton

Публикации

  • West DWD, Abou Sawan S, Mazzulla M, Williamson E, Moore DR. Whey Protein Supplementation Enhances Whole Body Protein Metabolism and Performance Recovery after Resistance Exercise: A Double-Blind Crossover Study. Nutrients. 2017 Jul 11;9(7):735. doi: 10.3390/nu9070735. PMID 28696380
  • Patel S. Emerging trends in nutraceutical applications of whey protein and its derivatives. J Food Sci Technol. 2015 Nov;52(11):6847-58. doi: 10.1007/s13197-015-1894-0. Epub 2015 Jun 9. PMID 26884639
  • Norton LE, Wilson GJ, Layman DK, Moulton CJ, Garlick PJ. Leucine content of dietary proteins is a determinant of postprandial skeletal muscle protein synthesis in adult rats. Nutr Metab (Lond). 2012 Jul 20;9(1):67. doi: 10.1186/1743-7075-9-67. PMID 22818257
  • Joy JM, Lowery RP, Wilson JM, Purpura M, De Souza EO, Wilson SM, Kalman DS, Dudeck JE, Jager R. The effects of 8 weeks of whey or rice protein supplementation on body composition and exercise performance. Nutr J. 2013 Jun 20;12:86. doi: 10.1186/1475-2891-12-86. PMID 23782948
  • Cermak NM, Res PT, de Groot LC, Saris WH, van Loon LJ. Protein supplementation augments the adaptive response of skeletal muscle to resistance-type exercise training: a meta-analysis. Am J Clin Nutr. 2012 Dec;96(6):1454-64. doi: 10.3945/ajcn.112.037556. Epub 2012 Nov 7. PMID 23134885
  • Banaszek A, Townsend JR, Bender D, Vantrease WC, Marshall AC, Johnson KD. The Effects of Whey vs. Pea Protein on Physical Adaptations Following 8-Weeks of High-Intensity Functional Training (HIFT): A Pilot Study. Sports (Basel). 2019 Jan 4;7(1):12. doi: 10.3390/sports7010012. PMID 30621129

Идентификаторы

NCT: NCT07561619 · Pro00156043

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗