Trial Summary
What is the purpose of this trial?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.
What safety data exists for plant and whey protein supplements?The safety data for plant and whey protein supplements includes studies on soy protein isolate and whey protein isolate. In rats, soy protein did not show significant differences in food consumption, body weights, or serum markers compared to other protein sources. In humans, soy protein increased plasma isoflavone concentrations but did not significantly affect cholesterol or platelet aggregation. A study on patients with milk or soy protein enterocolitis showed some adverse reactions to soy protein, indicating potential immune responses. Overall, these studies suggest that while soy and whey proteins are generally safe, individual reactions may vary, especially in those with specific protein sensitivities.236710
Do I have to stop taking my current medications for the trial?The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you are using long-term oral corticosteroids or have used a short course of oral corticosteroids within 4 weeks before the study. Also, you must not use protein or amino acid supplements within 5 days of the study.
Is Organic Pea Protein Isolate, Soy Protein Isolate, and Whey Protein Isolate a promising treatment for protein metabolism?Yes, these protein isolates are promising for protein metabolism. Whey Protein Isolate is particularly effective, providing a high amount of essential amino acids, which are important for muscle building and repair. Soy Protein Isolate is a good plant-based alternative with nutritional quality comparable to animal proteins. Pea Protein Isolate also contributes to a sustainable diet and offers a decent amount of essential amino acids.1691011
What data supports the idea that Plant vs Whey Protein for Protein Metabolism is an effective treatment?The available research shows that both plant-based and whey proteins can be effective for protein metabolism, but they have different strengths. For example, a study found that soy protein improved muscle function in rats, suggesting it can be beneficial for muscle growth. Another study showed that soy protein helped lower certain cholesterol levels in healthy men. However, when comparing plant-based protein blends to whey protein, the plant proteins were not as effective in raising essential amino acid levels in the blood, which are important for muscle building. Overall, while plant proteins like soy can be beneficial, whey protein might be more effective for rapid muscle growth due to its higher amino acid availability.45789
Eligibility Criteria
This trial is for older adults with sarcopenia, which is a condition involving loss of muscle mass and strength. Participants should be interested in how different protein sources affect their metabolism.Inclusion Criteria
I am between 50 and 95 years old.
Exclusion Criteria
I am currently taking long-term oral corticosteroids.
I am scheduled for a surgery that will keep me in the hospital for 2 or more days.
I have never been treated for liver or kidney disorders.
I have had a hysterectomy.
I have a severe illness or an unstable chronic condition.
I am currently being treated for a chronic condition like diabetes, cancer, heart, kidney, liver disease, HIV/AIDS, severe asthma, or hepatitis.
I have had a fever in the last 3 days.
My cognitive function test score is below 23.
Treatment Details
The study aims to compare the effects of plant-based proteins (soy and pea) and animal-based whey protein on muscle building responses in aging individuals. It also looks at whether water, used as a placebo, has any effect.
6Treatment groups
Experimental Treatment
Group I: Sarcopenic male old older adultsExperimental Treatment4 Interventions
Dietary Supplement: Whey Protein Isolate 90%. Commercially available Dietary Supplement: Soy Protein Isolate (90% Protein). Commercially available Dietary Supplement: Organic Pea Protein Isolate. Commercially available Dietary Supplement: Placebo - Water
Group II: Sarcopenic female old older adultsExperimental Treatment4 Interventions
Dietary Supplement: Whey Protein Isolate 90%. Commercially available Dietary Supplement: Soy Protein Isolate (90% Protein). Commercially available Dietary Supplement: Organic Pea Protein Isolate. Commercially available Dietary Supplement: Placebo - Water
Group III: Healthy male older adultsExperimental Treatment4 Interventions
Dietary Supplement: Whey Protein Isolate 90%. Commercially available Dietary Supplement: Soy Protein Isolate (90% Protein). Commercially available Dietary Supplement: Organic Pea Protein Isolate. Commercially available Dietary Supplement: Placebo - Water
Group IV: Healthy male old older adultsExperimental Treatment4 Interventions
Dietary Supplement: Whey Protein Isolate 90%. Commercially available Dietary Supplement: Soy Protein Isolate (90% Protein). Commercially available Dietary Supplement: Organic Pea Protein Isolate. Commercially available Dietary Supplement: Placebo - Water
Group V: Healthy female older adultsExperimental Treatment4 Interventions
Dietary Supplement: Whey Protein Isolate 90%. Commercially available Dietary Supplement: Soy Protein Isolate (90% Protein). Commercially available Dietary Supplement: Organic Pea Protein Isolate. Commercially available Dietary Supplement: Placebo - Water
Group VI: Healthy female old older adultsExperimental Treatment4 Interventions
Dietary Supplement: Whey Protein Isolate 90%. Commercially available Dietary Supplement: Soy Protein Isolate (90% Protein). Commercially available Dietary Supplement: Organic Pea Protein Isolate. Commercially available Dietary Supplement: Placebo - Water
Find a clinic near you
Research locations nearbySelect from list below to view details:
Texas A&M University - CTRALCollege Station, TX
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Who is running the clinical trial?
Texas A&M UniversityLead Sponsor
References
Evaluation of the protein quality of an isolated soy protein in young men: relative nitrogen requirements and effect of methionine supplementation. [2023]The protein nutritional value of an isolated soy protein (Supro-620) was evaluated in a series of nitrogen balance studies in healthy young male MIT students. Experiment 1 involved giving eight subjects graded intakes of the isolated soy protein while seven additional subjects received egg protein. Mean nitrogen intake required for N balance for the isolated soy protein and the egg protein were not significantly different (p greater than 0.1). In experiment 2, nine subjects received soy and the effects on N balance at various levels of L-methionine supplementation were studied. In experiment 3 eight subjects each were studied at two nitrogen intake levels of isolated soy protein/kg/day with methionine supplementation, and an unsupplemented egg protein period included. Results from experiment 2 and 3 at an 82 mg N/kg/day test level showed that N balance for 1.6% supplementation was significantly below that of unsupplemented egg while 1.1% and unsupplemented soy were indistinguishable from egg. No beneficial effects of methionine supplementation were observed when the test nitrogen intake level was 128 mg N/kg/day. These results indicate that for healthy adults, the isolated soy protein is of high nutritional quality, comparable to that of animal protein sources, and that the methionine content is not limiting for adult protein maintenance.
Prospective oral food challenge study of two soybean protein isolates in patients with possible milk or soy protein enterocolitis. [2023]The soybean protein isolate used in powdered soybean formula is hydrolyzed more extensively than the isolate which is used in liquid soybean formula in most commercial soybean formulas. Previous in vitro studies have shown differences in human antibody response to these soybean protein isolates. Therefore, a prospective clinical study was undertaken to determine if there were differences in adverse reaction rates to these soybean protein isolates. Forty-three patients with possible milk- and/or soy-protein enterocolitis were enrolled in this study. Patients had 3 separate oral food challenges; using milk formula, soybean powder formula and soybean liquid formula. Ten (23%) patients challenged with milk had positive challenges. Fourteen (33%) patients challenged with powdered soy formula had positive challenges while thirteen (30%) challenged with liquid soy formula had positive challenges. In the 10 patients with positive milk challenges, 6 (60%) had a positive soy challenge. In the group with positive soy challenges, 5 reacted to the powdered soy challenge done first, but not the second challenge with the liquid soy formula, and 4 patients reacted to the liquid soy formula challenge done first, but not the second challenge with the powdered soy formula. These results indicate that a significant number of patients with milk protein enterocolitis have soy protein enterocolitis. In addition, an order effect can be demonstrated in the soy challenges because of the tendency to react to the first soy challenge regardless of the type of isolate. These results suggest that a local immune effect caused by the protein may be present.
A soy protein isolate rich in genistein and daidzein and its effects on plasma isoflavone concentrations, platelet aggregation, blood lipids and fatty acid composition of plasma phospholipid in normal men. [2018]The effects of consuming a soy protein isolate beverage powder (60 g/d for 28 d) vs. a casein supplement was evaluated in 20 male subjects who were randomly allocated into the two groups. A dramatic rise in plasma isoflavone concentrations was observed after supplementation in the soy protein group, the levels reaching 907 +/- 245 nmol/L for genistein (a 110-fold increase) and 498 +/- 102 nmol/L for daidzein (a 150-fold increase) as measured by isotope dilution gas chromatography - mass spectrometry. These concentrations are higher than previously reported for the plasma of Japanese subjects consuming a traditional diet (276 nmol/L and 107 nmol/L, respectively). No significant differences in collagen- or 9,11-dideoxy-11alpha, 9alpha-epoxymethanoprostaglandin F2alpha (U46619)-induced platelet aggregation were observed in platelet-rich plasma from the two groups; the increase in plasma isoflavonoids from soy protein supplementation is not sufficient to significantly inhibit platelet aggregation ex vivo. Similarly, plasma total and HDL-cholesterol were not affected by protein supplementation, possibly because the men were normocholesterolemic at entry. Analysis of plasma phospholipid polyunsaturated fatty acid composition showed no differences between soy protein and casein supplementation. Previous investigations reported a significant alteration in fatty acid status in animals fed soy protein relative to those fed casein. The present studies indicate that although soy protein supplementation to a typical Western diet can increase plasma concentrations of isoflavones, this may not necessarily be sufficient to counter heart disease risk factors such as high plasma cholesterol and platelet aggregation.
Nutritional value of [15N]-soy protein isolate assessed from ileal digestibility and postprandial protein utilization in humans. [2018]The purpose of this work was to assess the true oro-ileal digestibility, and to concurrently quantify the deamination of absorbed dietary nitrogen to examine the postprandial nutritional value of a soy protein isolate (SPI) in humans. To assess bioavailability and bioutilization of SPI, 10 healthy volunteers ingested 30 g of SPI, intrinsically and uniformly [15N]-labeled, added with 100 g of sucrose and water up to a final volume of 500 mL. True ileal digestibility was assessed by the [15N]-dilution method for 8 h by means of a naso-intestinal intubation technique. To describe and quantify exogenous nitrogen deamination for the same time period, urine and plasma samples were collected. True oro-ileal digestibility of SPI nitrogen was 91%. The amount of absorbed SPI amino acids used for nonoxidative disposal, i.e., postprandial biological value, was 86% 8 h after meal ingestion. Hence, net postprandial protein utilization of SPI was 78%. Compared to previous data that were assessed under the same condition in humans, the nutritional value of SPI is 92% of that in milk protein concentrate.
Effects of soy protein on levels of remnant-like particles cholesterol and vitamin E in healthy men. [2019]We determined the effects of soy protein isolate (SPI) intake on remnant-like particles (RLP), lipolytic enzymes, lipid transfer protein, transaminases, sex hormones, iron, calcium, and vitamin E in healthy men. In the first randomized, crossover experiment, 14 men were given either 20 g per day of SPI or nothing (control) for each 4-week segment. After 3 weeks of SPI intake, TG and RLP cholesterol levels were significantly lower than the baseline by 13.4% (p
Effects of synthetic and natural extraction chemicals on yield, composition and protein quality of soy protein isolates extracted from full-fat and defatted flours. [2020]With increasing preference for all-natural foods to those involving synthetic chemicals, native isoelectrically precipitated soy protein isolate (SPI) was prepared using amaranth (Amaranthus tricolor L.) lye (pH > 12.5) and lemon extract, (pH
Chronic dietary supplementation with soy protein improves muscle function in rats. [2018]Athletes as well as elderly or hospitalized patients use dietary protein supplementation to maintain or grow skeletal muscle. It is recognized that high quality protein is needed for muscle accretion, and can be obtained from both animal and plant-based sources. There is interest to understand whether these sources differ in their ability to maintain or stimulate muscle growth and function. In this study, baseline muscle performance was assessed in 50 adult Sprague-Dawley rats after which they were assigned to one of five semi-purified "Western" diets (n = 10/group) differing only in protein source, namely 19 kcal% protein from either milk protein isolate (MPI), whey protein isolate (WPI), soy protein isolate (SPI), soy protein concentrate (SPC) or enzyme-treated soy protein (SPE). The diets were fed for 8 weeks at which point muscle performance testing was repeated and tissues were collected for analysis. There was no significant difference in food consumption or body weights over time between the diet groups nor were there differences in terminal organ and muscle weights or in serum lipids, creatinine or myostatin. Compared with MPI-fed rats, rats fed WPI and SPC displayed a greater maximum rate of contraction using the in vivo measure of muscle performance (p
Amino Acid Availability of a Dairy and Vegetable Protein Blend Compared to Single Casein, Whey, Soy, and Pea Proteins: A Double-Blind, Cross-Over Trial. [2023]Protein quality is important for patients needing medical nutrition, especially those dependent on tube feeding. A blend of dairy and vegetable proteins (35% whey, 25% casein, 20% soy, 20% pea; P4) developed to obtain a more balanced amino acid profile with higher chemical scores, was compared to its constituent single proteins. Fourteen healthy elderly subjects received P4, whey, casein, soy, and pea (18 g/360 mL bolus) on five separate visits. Blood samples were collected at baseline until 240 min after intake. Amino acid availability was calculated using incremental maximal concentration (iCmax) and area under the curve (iAUC). Availability for P4 as a sum of all amino acids was similar to casein (iCmax and iAUC) and whey (iCmax) and higher vs. soy (iCmax and iAUC) and pea (iCmax). Individual amino acid availability (iCmax and iAUC) showed different profiles reflecting the composition of the protein sources: availability of leucine and methionine was higher for P4 vs. soy and pea; availability of arginine was higher for P4 vs. casein and whey. Conclusions: The P4 amino acid profile was reflected in post-prandial plasma levels and may be regarded as more balanced compared to the constituent single proteins.
Differential Responses of Blood Essential Amino Acid Levels Following Ingestion of High-Quality Plant-Based Protein Blends Compared to Whey Protein-A Double-Blind Randomized, Cross-Over, Clinical Trial. [2020]This study assessed the bio-equivalence of high-quality, plant-based protein blends versus Whey Protein Isolate (WPI) in healthy, resistance-trained men. The primary endpoint was incremental area under the curve (iAUC) of blood essential Amino Acids (eAAs) 4 hours after consumption of each product. Maximum concentration (Cmax) and time to maximum concentration (Tmax) of blood leucine were secondary outcomes. Subjects (n = 18) consumed three plant-based protein blends and WPI (control). An analysis of Variance model was used to assess for bio-equivalence of total sum of blood eAA concentrations. The total blood eAA iAUC ratios of the three blends were [90% CI]: #1: 0.66 [0.58-0.76]; #2: 0.71 [0.62-0.82]; #3: 0.60 [0.52-0.69], not completely within the pre-defined equivalence range [0.80-1.25], indicative of 30-40% lower iAUC versus WPI. Leucine Cmax of the three blends was not equivalent to WPI, #1: 0.70 [0.67-0.73]; #2: 0.72 [0.68-0.75]; #3: 0.65 [0.62-0.68], indicative of a 28-35% lower response. Leucine Tmax for two blends were similar to WPI (#1: 0.94 [0.73-1.18]; #2: 1.56 [1.28-1.92]; #3: 1.19 [0.95-1.48]). The plant-based protein blends were not bio-equivalent. However, blood leucine kinetic data across the blends approximately doubled from fasting concentrations, whereas blood Tmax data across two blends were similar to WPI. This suggests evidence of rapid hyperleucinemia, which correlates with a protein's anabolic potential.
Gel properties of okara dietary fiber-fortified soy protein isolate gel with/without NaCl. [2022]Soy protein isolate (SPI) is widely used as an alternative to animal-based protein, and its gelling property is essential for producing plant protein-based foods. Insoluble dietary fiber has been used to improve the properties of protein gels.
An Investigation of the Protein Quality and Temporal Pattern of Peripheral Blood Aminoacidemia following Ingestion of 0.33 g·kg-1 Body Mass Protein Isolates of Whey, Pea, and Fava Bean in Healthy, Young Adult Men. [2023]An increase in the intake of legumes is recommended in the promotion of plant-sourced (PSP) rather than animal-sourced (ASP) protein intake to produce a more sustainable diet. This study evaluated the quality of novel PSP isolates from pea (PEA) and fava bean (FAVA) and an ASP isolate of whey (WHEY) and compared the magnitude and temporal pattern of peripheral arterial aminoacidemia following ingestion of 0.33 g·kg-1 body mass of protein isolate in healthy young adult men (n = 9). Total indispensable amino acids (IAA) comprised 58% (WHEY), 46% (PEA), and 42% (FAVA) of the total amino acid (AA) composition, with the ingested protein providing 108% (WHEY), 77% (PEA), and 67% (FAVA) of the recommended per diem requirement of IAA. Reflecting the AA composition, the area under the curve (∆AUC0-180), post-ingestion increase in total IAA for WHEY was 41% (p < 0.001) and 57% (p < 0.001) greater than PEA and FAVA, respectively, with PEA exceeding FAVA by 28% (p = 0.003). As a sole-source, single-dose meal-size serving, the lower total IAA for PEA and FAVA would likely evoke a reduced post-prandial anabolic capacity compared to WHEY. Incorporated into a food matrix, the promotion of PSP isolates contributes to a more sustainable diet.