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临床试验/NCT03816579
NCT03816579已完成不适用

A Meal-based Comparison of Protein Quality, Complementary Proteins and Muscle Anabolism

The University of Texas Medical Branch, Galveston2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2019年3月26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
23
试验地点
2
主要终点
Acute muscle protein synthesis: PRO-B

研究概览

简要总结

To highlight the importance of protein quality rather than the total protein content of a meal, the investigators will demonstrate that unlike high quality proteins, a single meal containing 30 g of an incomplete protein source does not stimulate skeletal muscle protein synthesis. Secondly, the investigators will directly challenge a prevalent, but untested, assertion that has the potential to negatively impact health. The goal is to demonstrate that complementary plant-proteins (i.e., two or more incomplete protein sources) must be consumed at the same meal to stimulate protein synthesis.

详细描述

The investigators will test the following hypotheses in middle-aged men and women (45-60) years old using a randomized, cross over design. All study objectives will be met concurrently:

  1. Meals containing 30 g of high quality, predominantly beef-protein (PRO-A) will stimulate acute (i.e., single meal response) and 24 h skeletal muscle protein synthesis [confirmatory hypothesis]
  2. Meals containing 30 g of complementary plant-based proteins (PRO-B: complete essential amino acid profile at each meal) will stimulate acute and 24 h skeletal muscle protein synthesis, but to a lesser extent than beef-protein.
  3. A single meal containing 30 g of an incomplete plant-based protein source (PRO-C: lacking one essential amino acid) will fail to acutely stimulate skeletal muscle protein synthesis
  4. Meals containing 30 g of plant-based protein that are incomplete at each separate meal, but complementary over a 24 h period, will fail to stimulate 24 h skeletal muscle protein synthesis.
  5. Beef-and plant-based meals will have a similar effect on satiety and 24 h blood glucose [descriptive]

If these hypotheses are correct, the investigators will demonstrate that meals containing a moderate amount of high quality protein, such as beef, are an efficient and effective way to augment a largely plant based diet and stimulate skeletal muscle protein synthesis - a prerequisite for outcomes related to physical function, performance, successful aging and metabolic health.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
45 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • All races and ethnic backgrounds
  • Men and women, age 45-60 years
  • Generally healthy (see exclusion criteria)
  • Able and willing to provide informed consent
  • Ability to speak and read English (* the study procedures, e.g., muscle biopsy, duration of each acute study, e.g. overnight stay; and multiple dietary questionnaires require sound written and spoken English)

排除标准

  • Sarcopenia (defined by: European Working Group on Sarcopenia in Older People, EWGSOP (44))
  • Clinically significant heart disease (e.g. New York Heart Classification greater than grade II; ischemia)
  • Peripheral vascular disease
  • Pulmonary disease
  • History of systemic or pulmonary embolus
  • Uncontrolled blood pressure (systolic BP>170, diastolic BP>95 mmHg)
  • Impaired renal function (creatinine >1.5 mg/dl)
  • Anemia (hematocrit <33)
  • Untreated thyroid disease (abnormal TSH)
  • A recent history (<12 months) of GI bleed
  • Diabetes mellitus or other untreated endocrine or metabolic disease
  • Electrolyte abnormalities
  • Any history of stroke, hypo- or hyper-coagulation disorders
  • Recent (3 years) treated cancer other than basal cell carcinoma
  • Systemic steroids, anabolic steroids, growth hormone or immunosuppressant use within 12 months
  • Recent (6 months) adherence to a weight-loss or weight-gain diet
  • Weight change of 5% or more in previous 6 months
  • Body mass index >30 or excess body fat that compromises muscle biopsy collection
  • Body mass index <20 or recent history (<12 month) of disordered eating
  • Dietary preferences or practices that preclude the consumption of the study meals
  • Acute infectious disease or chronic infection
  • Alcohol or drug abuse
  • Any other condition or event considered exclusionary by study physician

结局指标

主要结局

Acute muscle protein synthesis: PRO-B

时间窗: 3 hours after consuming meal

Muscle protein synthesis response to PRO-B breakfast meal (%/h)

Acute muscle protein synthesis: PRO-A

时间窗: 3 hours after consuming meal

Muscle protein synthesis response to PRO-A breakfast meal (%/h)

Blood amino acid response to diet: PRO-A

时间窗: Approximately 5 hours

Blood samples will be drawn to measure amino acid concentrations response to PRO-A breakfast (µmol/L)

24-hour muscle protein synthesis: PRO-B

时间窗: Approximately 24 hours

Muscle protein synthesis response to PRO-B diet over 24 hours (%/hour)

Acute muscle protein synthesis: CON

时间窗: 3 hours after consuming meal

Muscle protein synthesis response to CON breakfast meal (%/hour)

24-hour muscle protein synthesis: PRO-A

时间窗: Approximately 24 hours

Muscle protein synthesis response to PRO-A diet over 24 hours (%/hour)

24-hour muscle protein synthesis: PRO-C

时间窗: Approximately 24 hours

Muscle protein synthesis response to PRO-C diet over 24 hours (%/hour)

Blood amino acid response to diet: PRO-C

时间窗: Approximately 5 hours

Blood samples will be drawn to measure amino acid concentrations response to PRO-B C breakfast (µmol/L)

Blood amino acid response to diet: CON

时间窗: Approximately 5 hours

Blood samples will be drawn to measure amino acid concentrations response to CON breakfast (µmol/L)

Acute muscle protein synthesis: PRO-C

时间窗: 3 hours after consuming meal

Muscle protein synthesis response to PRO-C breakfast meal (%/h)

Blood amino acid response to diet: PRO-B

时间窗: Approximately 5 hours

Blood samples will be drawn to measure amino acid concentrations response to PRO-B breakfast (µmol/L)

次要结局

  • Blood glucose response to diet: PRO-A(Approximately 24 hours)
  • Blood glucose response to diet: PRO-B(Approximately 24 hours)
  • 3 day dietary record: CON(Approximately 36 hours)
  • Palatability Questionnaire:CON(Approximately 5 hours)
  • Blood glucose response to diet: PRO-C(Approximately 24 hours)
  • Blood glucose response to diet: CON(Approximately 5 hours)
  • Appetite and Hedonic Questionnaire: PRO-A(Approximately 8 hours)
  • Appetite and Hedonic Questionnaire: PRO-B(Approximately 8 hours)
  • Appetite and Hedonic Questionnaire: CON(Approximately 5 hours)
  • 3 day dietary record: PRO-A(Approximately 36 hours)
  • Palatability Questionnaire:PRO-C(Approximately 8 hours)
  • Appetite and Hedonic Questionnaire: PRO-C(Approximately 8 hours)
  • 3 day dietary record: PRO-B(Approximately 36 hours)
  • 3 day dietary record: PRO-C(Approximately 36 hours)
  • Palatability Questionnaire:PRO-A(Approximately 8 hours)
  • Palatability Questionnaire:PRO-B(Approximately 8 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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