A Meal-based Comparison of Protein Quality, Complementary Proteins and Muscle Anabolism (MAPP)
27 april 2021 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
23
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
Texas
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Galveston, Texas, Verenigde Staten, 77555
- Unversity of Texas Medical Branch
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
45 jaar tot 60 jaar (Volwassen)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: PRO-A
Beef protein
|
30 g of beef protein will be consumed at each meal
|
|
Experimenteel: PRO-B
Complementary proteins at each meal
|
30 g of complementary proteins will be consumed at each meal
|
|
Experimenteel: PRO-C
Complementary proteins over 24 hours
|
30 g of complementary proteins will be consumed over 24 hours
|
|
Geen tussenkomst: CON
Low protein (<5 g) meal
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Acute muscle protein synthesis: PRO-A
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Approximately 5 hours
|
Blood samples will be drawn to measure amino acid concentrations response to CON breakfast (µmol/L)
|
Approximately 5 hours
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Blood glucose response to diet: PRO-A
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: Doug Paddon-Jones, PhD, University of Texas
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
26 maart 2019
Primaire voltooiing (Werkelijk)
21 januari 2021
Studie voltooiing (Werkelijk)
21 januari 2021
Studieregistratiedata
Eerst ingediend
22 januari 2019
Eerst ingediend dat voldeed aan de QC-criteria
24 januari 2019
Eerst geplaatst (Werkelijk)
25 januari 2019
Updates van studierecords
Laatste update geplaatst (Werkelijk)
29 april 2021
Laatste update ingediend die voldeed aan QC-criteria
27 april 2021
Laatst geverifieerd
1 december 2020
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- 18-0147
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Nee
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
product vervaardigd in en geëxporteerd uit de V.S.
Nee
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