Changes in Amino Acid Absorption After Adding a Probiotic to an Acute Protein Feeding

Официальное название

Comparative Differences of Amino Acid Appearance with Milk Protein Ingestion with and Without Probiotic Supplementation

Обзор

The purpose of this study is to examine the rate and concentration of amino acid absorption after a three-week pattern of milk protein supplementation with and without the addition of a single strain probiotic.

Подробное описание

The study will be conducted using a randomized, double-blind, crossover study design. Thirty healthy men and women between 18 - 35 years of age will be recruited to participate in this study. Two supplementation protocols that each span three weeks will be completed and separated with a washout period of three weeks. Participants will be assigned in a randomized, double-blind, crossover fashion to ingest a single daily 25-gram dose of a powder milk protein and placebo or a single daily 25-gram dose of a powder milk protein plus a single strain probiotic. Upon arrival for each study visit, participants will have their resting heart rate, blood pressure, body mass, height, and body composition measured. On the day of experimental testing, subjects will arrive to the laboratory in a fasted state. Subjects will rest semi-supine for multiple blood sampling. Following baseline sampling, participants will ingest their respective supplement plus a standard bolus of milk protein (powder form, mixed with 12 fl oz of cold water). Thereafter, blood samples will be taken at 30, 60, 90, 120, 180, and 240 minutes post-ingestion. Study participants will be provided an additional three-week supply of the alternative treatment to begin after observing a three-week washout. After three weeks of supplementation, study participants will return to the laboratory for their remaining testing visit.

Вмешательства

• Пищевая добавка Single Strain Probiotic + Milk Protein
  • Both conditions matched flavor, color, and serving size
• Пищевая добавка Placebo + Milk Protein
  • Both conditions matched flavor, color, and serving size

Первичные конечные точки

• Rate of amino acid absorption [Срок оценки: Day 0, Day 22, Day 65]
• Concentration of amino acid absorption [Срок оценки: Day 0, Day 22, Day 65]

Вторичные конечные точки (2)

• Comprehensive metabolic panel [Срок оценки: Day 0, Day 22, Day 65]
• Blood CBC panel [Срок оценки: Day 0, Day 22, Day 65]

Критерии участия

Критерии включения

• Participants will be male or female between the ages of 18-35 years;
• Participants have not been consuming any nutritional supplements for the preceding 6-week period;
• Participants have not been consuming any ergogenic aids for the preceding 6-week period;
• Participant has provided written and dated informed consent to participate in the study;
• Participant is willing and able to comply with the protocol;
• Participant is apparently healthy and free from disease, as determined by a health history questionnaire;

Критерии исключения

• Participant is allergic to any ingredient in the nutritional supplement or placebo;
• Participant is not pregnant or trying to become pregnant, nor breast feeding;
• Participant reports any unusual adverse events associated with this study that in consultation with the study investigators or their doctor recommends removal from the study;
• Participant currently ingests nicotine or has quit within the last 6 months;

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• The University of Mary Hardin-Baylor — Belton

Идентификаторы

NCT: NCT06701604 · PCTB202104D

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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