Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06628349
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-04-26
Brief Title:
Prandial Metabolic Phenotyping in Sarcopenic Older Adults Comparing Plant Based and Whey Based Protein
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prandial Metabolic Phenotyping in Sarcopenic Older Adults Comparing Plant Based and Whey Based Protein
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The researchers overall objective is to determine whether plant and animal protein based proteins affect the anabolic responses across aging populations differently due to specific changes in the essential amino acids EAA and non-essential amino acids NEAA kinetic responses The researchers central hypothesis is that a high EAA to NEAA ratio in a protein meal is related to higher anabolic response to the meal The researchers also hypothesize that the type of NEAA in a protein meal also affects the anabolic capacity of the meal The researchers rationale is that finding the amino acid composition of a meal that will maximally induce protein anabolism will guide novel nutritional approaches to prevent and treat sarcopenia thereby reducing both overall economic burden and improving individual patient outcomes
Detailed Description:
The study will be conducted in sarcopenic and non-sarcopenic older adults stratified into different age categories A sip feeding model will be used as it is a good model to establish the anabolic capacity of meals The researchers hypothesize that plant-based protein induces less protein anabolism due to lower production of EAA and higher production of non-essential amino acids NEAA as compared to dairy protein The NEAA kinetics will be different between the plant proteins as soy protein has relatively high levels of the NEAA arginine and Pea protein of aspartateglutamate The researchers results will guide future nutritional advice on replacing daily protein with plant-based proteins while keeping the overall effects on metabolism comparable for both the EAA and NEAA The study will take place at the research facility of the Center for Translational Research on Aging and Longevity CTRAL Texas AM University located in the Human Clinical Research Building affiliated with Texas AM University The study involves 1 screening visit of approx 3 hours and 4 study days Some study procedures eg body composition skeletal muscle function questionnaires may be skipped if completed within the past 3 months at CTRAL All data will be recorded in Case Report Form and stored in the Texas AM REDCap System Subjects will be asked to arrive in the fasted state on all study days Fasting prior to screening is not required On the screening day body weight height and body composition by Dual-energy X-ray absorptiometry DXA will be measured In addition The Six-Minute Walk Test 6MWT and skeletal muscle function tests will be assessed at the end of each screening visit Each study visit will begin with vital signs Before administration of the feeding or the tracer solution baseline blood will be collected for measurement of the natural enrichment of metabolites After the baseline sample is collected feeding will begin and will be followed by tracers of several compounds that may be administered by IV pulse Participants will receive the liquid nutritional supplement as sip feeds every 20 minutes for 5 hours The liquid nutrition supplements will contain the following proteins 1 45g of whey protein dairy based 2 45g of soy protein plant based 3 45g of pea protein plant based or 4 Placebo water Participants will have the option of adding sugar free SF vanilla syrup SF caramel syrup or SF chocolate syrup to their meals
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None