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临床试验/NCT04784806
NCT04784806已完成不适用

Amino Acid Profile and Muscle Protein Synthetic Response to Consuming Meat or Plant-based Alternatives

University of California, Davis2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2021年4月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
17
试验地点
2
主要终点
Quantification of muscle protein synthesis rates in vitro

研究概览

简要总结

The purpose of the study is to quantify and compare the serum amino acid profile, and muscle protein synthesis rates, in response to consuming isonitrogenous amounts of ground meat (beef and pork) or plant-based alternatives -(soy and pea protein-based patties).

Specific aim 1: Describe the post-prandial amino acid profile in serum in the 3 hours following consumption of the following four burger patties, in quantities calculated to deliver 20 grams of protein: ground beef, ground pork, Beyond Meat® burger, and tofu burger.

Specific aim 2: Compare the ability of these four different foods to activate mTORC1 and protein synthesis in muscle.

详细描述

Study design:

The first visit will be a brief meeting conducted over Zoom with one of the investigators (Karine Schaal), who will go over the study details with the volunteer, answer their questions, and obtain informed consent. Subjects will sign the informed consent electronically, using DocuSign. Subjects will be given a copy of their signed informed consent form. A paper copy of the consent form will be kept in a locked file cabinet in the office of the principal investigator.

Study volunteers will come to the CTSC Clinical Research Center (CCRC) on four separate occasions. The CCRC is located in the Cypress Building adjacent to the UC Davis Medical Center (2221 Stockton Blvd, Suite D, Sacramento CA 95817).

The four study visits will be test visits scheduled over a two week period (i.e. twice per week for 2 weeks), at the same time in the morning following and overnight (> 12 hour) fast. They will be asked to refrain from vigorous exercise, caffeine, nicotine and alcohol for 24 hours prior to each visit. Female volunteers will be asked to schedule their study visits within the first two weeks of their menstrual cycle (starting on the first day of menstrual bleeding), in order to control for ovarian hormone fluctuations which may impact digestion and metabolism.

Upon arrival to the CCRC on the first test visit, each volunteer's height and weight will be measured.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy active male (n=8) and female (n=8) volunteers aged 18 - 30 years
  • normal weight (BMI between 18 and 25 kg/m2) will be recruited to participate in the study.
  • To be considered active, volunteers must meet the following American College of Sports Medicine's guideline for physical activity for healthy adults: performing at least 150 minutes per week of moderate-to-vigorous intensity physical activity.

排除标准

  • Health or dietary restriction that would be affected by the foods consumed.
  • Known food allergy to legumes (soybeans, peas, peanuts) or meat (beef or pork)
  • Anemia (low red blood cell count)
  • Overweight or obesity (BMI > 25 kg/m2)
  • Currently not meeting the ACSM physical activity recommendations (IPAQ score < 150 min/week of moderate-to-vigorous physical activity)
  • Metabolic or endocrine disorder that would affect the digestion, absorption, and/or physiological response to any of the nutrients ingested
  • Receiving any medication that may interfere with the study
  • Adults unable to consent
  • Individuals who are not yet adults (infants, children, teenagers)
  • Pregnant women
  • Prisoners

结局指标

主要结局

Quantification of muscle protein synthesis rates in vitro

时间窗: Baseline and 30, 60, 90, 120 and 180 minutes after consuming each test meal

The rest of the serum obtained from the procedures described in Outcome 1 will be used for developing the mTORC1 bioassay and quantify the rate of muscle protein synthesis in vitro.

Quantification of serum amino acid concentrations after consuming each test meal.

时间窗: Baseline and 30, 60, 90, 120 and 180 minutes after consuming each test meal

A fasted 3.5mL baseline blood sample will be collected in serum separating tubes, after which subjects will consume one of the four patties. Five 3.5mL blood samples will be obtained at 30, 60, 90, 120 and 180 minutes following the patty consumption. Blood will be allowed to clot for 1hr before centrifugation at 1000 x g for 10 minutes. The serum will be frozen and kept at -80°C until processed. 100 microliters of each serum sample will be used for determining amino acid concentrations by high performance liquid chromatography (HPLC) at the UC Davis Proteomics Core.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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