A Meal-based Comparison of Protein Quality, Complementary Proteins and Muscle Anabolism (MAPP)
2021年4月27日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
23
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Texas
-
Galveston、Texas、アメリカ、77555
- Unversity of Texas Medical Branch
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
45年～60年 (大人)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：PRO-A
Beef protein
|
30 g of beef protein will be consumed at each meal
|
|
実験的：PRO-B
Complementary proteins at each meal
|
30 g of complementary proteins will be consumed at each meal
|
|
実験的：PRO-C
Complementary proteins over 24 hours
|
30 g of complementary proteins will be consumed over 24 hours
|
|
介入なし：CON
Low protein (<5 g) meal
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Acute muscle protein synthesis: PRO-A
時間枠：3 hours after consuming meal
|
Muscle protein synthesis response to PRO-A breakfast meal (%/h)
|
3 hours after consuming meal
|
|
Acute muscle protein synthesis: PRO-B
時間枠：3 hours after consuming meal
|
Muscle protein synthesis response to PRO-B breakfast meal (%/h)
|
3 hours after consuming meal
|
|
Acute muscle protein synthesis: PRO-C
時間枠：3 hours after consuming meal
|
Muscle protein synthesis response to PRO-C breakfast meal (%/h)
|
3 hours after consuming meal
|
|
Acute muscle protein synthesis: CON
時間枠：3 hours after consuming meal
|
Muscle protein synthesis response to CON breakfast meal (%/hour)
|
3 hours after consuming meal
|
|
24-hour muscle protein synthesis: PRO-A
時間枠：Approximately 24 hours
|
Muscle protein synthesis response to PRO-A diet over 24 hours (%/hour)
|
Approximately 24 hours
|
|
24-hour muscle protein synthesis: PRO-B
時間枠：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
時間枠：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
時間枠：Approximately 5 hours
|
Blood samples will be drawn to measure amino acid concentrations response to PRO-A breakfast (µmol/L)
|
Approximately 5 hours
|
|
Blood amino acid response to diet: PRO-B
時間枠：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
時間枠：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
時間枠：Approximately 5 hours
|
Blood samples will be drawn to measure amino acid concentrations response to CON breakfast (µmol/L)
|
Approximately 5 hours
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Blood glucose response to diet: PRO-A
時間枠：Approximately 24 hours
|
Blood samples will be drawn to measure blood glucose response to PRO-A diet (mg/dl)
|
Approximately 24 hours
|
|
Blood glucose response to diet: PRO-B
時間枠：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
時間枠：Approximately 24 hours
|
Blood samples will be drawn to measure blood glucose response to PRO-C diet (mg/dl)
|
Approximately 24 hours
|
|
Blood glucose response to diet: CON
時間枠：Approximately 5 hours
|
Blood samples will be drawn to measure blood glucose response to CON breakfast meal (mg/dl)
|
Approximately 5 hours
|
|
Appetite and Hedonic Questionnaire: PRO-A
時間枠：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-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.
|
Approximately 8 hours
|
|
Appetite and Hedonic Questionnaire: PRO-B
時間枠：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
時間枠：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.
|
Approximately 8 hours
|
|
Appetite and Hedonic Questionnaire: CON
時間枠：Approximately 5 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 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.
|
Approximately 5 hours
|
|
3 day dietary record: PRO-A
時間枠：Approximately 36 hours
|
Diet records will be collected and analyzed with ASA24 to assess habitual energy intake the week prior to PRO-A study visit
|
Approximately 36 hours
|
|
3 day dietary record: PRO-B
時間枠：Approximately 36 hours
|
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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Doug Paddon-Jones, PhD、University of Texas
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2019年3月26日
一次修了 (実際)
2021年1月21日
研究の完了 (実際)
2021年1月21日
試験登録日
最初に提出
2019年1月22日
QC基準を満たした最初の提出物
2019年1月24日
最初の投稿 (実際)
2019年1月25日
学習記録の更新
投稿された最後の更新 (実際)
2021年4月29日
QC基準を満たした最後の更新が送信されました
2021年4月27日
最終確認日
2020年12月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- 18-0147
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
米国で製造され、米国から輸出された製品。
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。