A Meal-based Comparison of Protein Quality, Complementary Proteins and Muscle Anabolism (MAPP)
2021년 4월 27일 업데이트: The University of Texas Medical Branch, Galveston
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.
연구 개요
상세 설명
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:
- 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]
- 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.
- 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
- 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.
- 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.
연구 유형
중재적
등록 (실제)
23
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Texas
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Galveston, Texas, 미국, 77555
- Unversity of Texas Medical Branch
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
45년 (성인)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
- Pregnancy
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: PRO-A
Beef protein
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30 g of beef protein will be consumed at each meal
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실험적: PRO-B
Complementary proteins at each meal
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30 g of complementary proteins will be consumed at each meal
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실험적: PRO-C
Complementary proteins over 24 hours
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30 g of complementary proteins will be consumed over 24 hours
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|
간섭 없음: CON
Low protein (<5 g) meal
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Acute muscle protein synthesis: PRO-A
기간: 3 hours after consuming meal
|
Muscle protein synthesis response to PRO-A breakfast meal (%/h)
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3 hours after consuming meal
|
|
Acute muscle protein synthesis: PRO-B
기간: 3 hours after consuming meal
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Muscle protein synthesis response to PRO-B breakfast meal (%/h)
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3 hours after consuming meal
|
|
Acute muscle protein synthesis: PRO-C
기간: 3 hours after consuming meal
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Muscle protein synthesis response to PRO-C breakfast meal (%/h)
|
3 hours after consuming meal
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Acute muscle protein synthesis: CON
기간: 3 hours after consuming meal
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Muscle protein synthesis response to CON breakfast meal (%/hour)
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3 hours after consuming meal
|
|
24-hour muscle protein synthesis: PRO-A
기간: Approximately 24 hours
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Muscle protein synthesis response to PRO-A diet over 24 hours (%/hour)
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Approximately 24 hours
|
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24-hour muscle protein synthesis: PRO-B
기간: Approximately 24 hours
|
Muscle protein synthesis response to PRO-B diet over 24 hours (%/hour)
|
Approximately 24 hours
|
|
24-hour muscle protein synthesis: PRO-C
기간: Approximately 24 hours
|
Muscle protein synthesis response to PRO-C diet over 24 hours (%/hour)
|
Approximately 24 hours
|
|
Blood amino acid response to diet: PRO-A
기간: Approximately 5 hours
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Blood samples will be drawn to measure amino acid concentrations response to PRO-A breakfast (µmol/L)
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Approximately 5 hours
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Blood amino acid response to diet: PRO-B
기간: Approximately 5 hours
|
Blood samples will be drawn to measure amino acid concentrations response to PRO-B breakfast (µmol/L)
|
Approximately 5 hours
|
|
Blood amino acid response to diet: PRO-C
기간: Approximately 5 hours
|
Blood samples will be drawn to measure amino acid concentrations response to PRO-B C breakfast (µmol/L)
|
Approximately 5 hours
|
|
Blood amino acid response to diet: CON
기간: Approximately 5 hours
|
Blood samples will be drawn to measure amino acid concentrations response to CON breakfast (µmol/L)
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Approximately 5 hours
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Blood glucose response to diet: PRO-A
기간: Approximately 24 hours
|
Blood samples will be drawn to measure blood glucose response to PRO-A diet (mg/dl)
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Approximately 24 hours
|
|
Blood glucose response to diet: PRO-B
기간: Approximately 24 hours
|
Blood samples will be drawn to measure blood glucose response to PRO-B diet (mg/dl)
|
Approximately 24 hours
|
|
Blood glucose response to diet: PRO-C
기간: Approximately 24 hours
|
Blood samples will be drawn to measure blood glucose response to PRO-C diet (mg/dl)
|
Approximately 24 hours
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Blood glucose response to diet: CON
기간: Approximately 5 hours
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Blood samples will be drawn to measure blood glucose response to CON breakfast meal (mg/dl)
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Approximately 5 hours
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Appetite and Hedonic Questionnaire: PRO-A
기간: Approximately 8 hours
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Questionnaires will be given to assess hunger, fullness, desire to eat, thirst, desire to eat something sweet, desire to eat something salty, desire to eat something savory, sleepiness, physical energy, mental energy, and nausea in response to PRO-A diet.
All outcomes are scored individually on a 10 pt visual analog scale using "not at all" being 0 and "extremely" being a 10.
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Approximately 8 hours
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|
Appetite and Hedonic Questionnaire: PRO-B
기간: Approximately 8 hours
|
Questionnaires will be given to assess hunger, fullness, desire to eat, thirst, desire to eat something sweet, desire to eat something salty, desire to eat something savory, sleepiness, physical energy, mental energy, and nausea in response to PRO-B diet.
All outcomes are scored individually on a 10 pt visual analog scale using "not at all" being 0 and "extremely" being a 10.
|
Approximately 8 hours
|
|
Appetite and Hedonic Questionnaire: PRO-C
기간: Approximately 8 hours
|
Questionnaires will be given to assess hunger, fullness, desire to eat, thirst, desire to eat something sweet, desire to eat something salty, desire to eat something savory, sleepiness, physical energy, mental energy, and nausea in response to PRO-C diet.
All outcomes are scored individually on a 10 pt visual analog scale using "not at all" being 0 and "extremely" being a 10.
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Approximately 8 hours
|
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Appetite and Hedonic Questionnaire: CON
기간: Approximately 5 hours
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Questionnaires will be given to assess hunger, fullness, desire to eat, thirst, desire to eat something sweet, desire to eat something salty, desire to eat something savory, sleepiness, physical energy, mental energy, and nausea in response to CON diet.
All outcomes are scored individually on a 10 pt visual analog scale using "not at all" being 0 and "extremely" being a 10.
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Approximately 5 hours
|
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3 day dietary record: PRO-A
기간: Approximately 36 hours
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Diet records will be collected and analyzed with ASA24 to assess habitual energy intake the week prior to PRO-A study visit
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Approximately 36 hours
|
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3 day dietary record: PRO-B
기간: Approximately 36 hours
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Diet records will be collected and analyzed with ASA24 to assess habitual energy intake the week prior to PRO-B study visit
|
Approximately 36 hours
|
|
3 day dietary record: PRO-C
기간: Approximately 36 hours
|
Diet records will be collected and analyzed with ASA24 to assess habitual energy intake the week prior to PRO-C study visit
|
Approximately 36 hours
|
|
3 day dietary record: CON
기간: Approximately 36 hours
|
Diet records will be collected and analyzed with ASA24 to assess habitual energy intake the week prior to CON study visit
|
Approximately 36 hours
|
|
Palatability Questionnaire:PRO-A
기간: Approximately 8 hours
|
Questionnaires will be given to assess palatability of the PRO-A diet.
Outcomes include the participants ranking of the food appearance, aroma intensity, aroma, flavor intensity, flavor, texture and overall appeal of the food.
A 10 pt visual analog scale will be used to assess the subject's response with 0 being "extremely dislike", 5 being "neither like nor dislike" and 10 being "extremely like".
|
Approximately 8 hours
|
|
Palatability Questionnaire:PRO-B
기간: Approximately 8 hours
|
Questionnaires will be given to assess palatability of the PRO-B diet.
Outcomes include the participants ranking of the food appearance, aroma intensity, aroma, flavor intensity, flavor, texture and overall appeal of the food.
A 10 pt visual analog scale will be used to assess the subject's response with 0 being "extremely dislike", 5 being "neither like nor dislike" and 10 being "extremely like".
|
Approximately 8 hours
|
|
Palatability Questionnaire:PRO-C
기간: Approximately 8 hours
|
Questionnaires will be given to assess palatability of the PRO-C diet.
Outcomes include the participants ranking of the food appearance, aroma intensity, aroma, flavor intensity, flavor, texture and overall appeal of the food.
A 10 pt visual analog scale will be used to assess the subject's response with 0 being "extremely dislike", 5 being "neither like nor dislike" and 10 being "extremely like".
|
Approximately 8 hours
|
|
Palatability Questionnaire:CON
기간: Approximately 5 hours
|
Questionnaires will be given to assess palatability of the CON diet.
Outcomes include the participants ranking of the food appearance, aroma intensity, aroma, flavor intensity, flavor, texture and overall appeal of the food.
A 10 pt visual analog scale will be used to assess the subject's response with 0 being "extremely dislike", 5 being "neither like nor dislike" and 10 being "extremely like".
|
Approximately 5 hours
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Doug Paddon-Jones, PhD, University of Texas
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2019년 3월 26일
기본 완료 (실제)
2021년 1월 21일
연구 완료 (실제)
2021년 1월 21일
연구 등록 날짜
최초 제출
2019년 1월 22일
QC 기준을 충족하는 최초 제출
2019년 1월 24일
처음 게시됨 (실제)
2019년 1월 25일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 4월 29일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 4월 27일
마지막으로 확인됨
2020년 12월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 18-0147
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이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .