Evaluation of Amino Acids Bioavailability in a Food Product Based on a Vegetable Protein Combination: a Randomized, Double-blind Crossover Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 12
- Locations
- 2
- Primary Endpoint
- Bioavailability of essential aminoacids calculated by the Area Under The Curve (EAA-AUC 0-240min) of plasma essential aminoacids levels.
Study Overview
Brief Summary
Proteins can be classified as high or low biological value proteins depending on their composition in essential amino acids, which are those amino acids that the body cannot synthesize and must be provided through food. In recent years, there has been growing interest in reducing the consumption of proteins of animal origin, leading to the search for more sustainable protein options, such as vegetable proteins. However, vegetable options do not have a complete profile of essential amino acids. In this sense, soy protein is considered the reference vegetable protein because it has an adequate amino acid profile. However, the amount of methionine is considerably lower than that of an animal source, and it also has a considerable allergenic potential. The mixture of two types of complementary vegetable protein sources could serve as a strategy to achieve the profile of essential amino acids like that of an animal protein.
The hypothesis of the present study is that the consumption of a mixture of vegetable proteins from legume and cereal sources will complement each other to achieve a bioavailability of essential amino acids equal to or greater than that observed when consuming soy protein.
Detailed Description
An adequate protein intake is essential for the body's well-being and performance, because the body uses this nutrient in many cellular functions.
Proteins are nitrogen-containing substances made up of amino acids (AA). Not only the quantity but also the quality of protein in the diet is important for the body's proper functioning. Protein quality depends on the AA profile, among other factors. 20 total AA (TAA) have been identified as necessary for human growth and metabolism. Of the 20 TAAs, nine of them are defined as essential AA (EAAs, histidine, isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan and valine), and the remaining eleven are considered non-essential AA (NEAAs, alanine, arginine, asparagine, aspartic acid, cysteine, glutamic acid, glutamine, glycine, proline, serine and tyrosine). In addition, branched-chain amino acids (BCAA, leucine, isoleucine, and valine) are found within the EAAs.
The NEAAs can be synthesized by the body, while the EAAs must be ingested from the diet. In this sense, proteins can be classified into two groups: high or low biological value, depending on the presence or absence of all the EAAs in their composition. Today, this distinction is usually called animal or vegetable proteins, respectively, because proteins from meat, eggs, and dairy products have higher amounts of EAAs, including leucine, while proteins from legumes, seeds, or nuts have a deficit in some of them.
In the diet, the consumption of a mixture of plant-based proteins (i.e., complementary proteins) is a common strategy to compensate for the fact that individual sources of plant-based proteins are often deficient in one or more EAAs. For example, the combination of rice protein (high in methionine but low in lysine) and pea protein (low in methionine but high in lysine) can produce a pea-rice protein blend with a balanced amino acid profile, free of deficiencies. Therefore, the formulation of a plant-based protein blend represents an opportunity to develop a high-quality protein option.
The present study has as its main objective to evaluate the postprandial bioavailability of EAA from two plant-based protein sources present in a complete powdered meal, where one will have soy protein and the other product with a protein source from a mixture of rice and pea protein.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Men and women between 18 and 50 years old.
- •Be willing to limit intentional physical exercise during the 24 hours prior to each day of testing.
- •Be willing to not consume alcoholic beverages 48 hours before the start of the study.
- •Sign the informed consent.
- •Be able to read, write and speak Spanish.
Exclusion Criteria
- •Present values of body mass index (BMI) ≤ 18kg/m^2 or ≥ 30 kg/m^
- •Present allergy or intolerance to any of the ingredients of the products to be evaluated, mainly pea flour, rice flour, soy, flax, spirulina or olive oil.
- •Follow a vegan or vegetarian diet.
- •Use of medication that affects muscle anabolism or metabolism in general.
- •Consume multivitamin supplements (Vit. D, Vit. E and Vit. C), minerals (Zinc, Selenium), essential fatty acids (omega-3), polyphenols, or any type of supplements that may affect oxidative or inflammatory metabolic pathways in the last 30 days before the start of the study.
- •Consumption of alcoholic beverages:
- •Men: consume 4 or more Standard Drink Units (SDU) daily or 28 SDU weekly.
- •Women: Consume 2 or more Standard Drink Units (SDU) daily or 17 SDU weekly.
- •Be an active smoker or have been one less than 6 months ago.
- •Have a chronic disease with clinical manifestations: coronary disease, cardiovascular disease, diabetes, celiac disease, Crohn's disease, chronic kidney disease, active cancer, gastrointestinal diseases that may compromise the absorption of the compound.
- •Take protein or amino acid supplements up to 1 week before the start of the study.
- •Perform vigorous exercise for more than 3 hours a week.
- •Have anemia.
- •Have lost 3 kg or more in the last 3 months.
- •Be pregnant or intend to become pregnant.
- •Be breastfeeding.
- •Not be able to follow the study guidelines.
- •Be participating or have participated in a clinical trial or nutritional intervention study in the last 30 days prior to inclusion in the study.
Outcomes
Primary Outcomes
Bioavailability of essential aminoacids calculated by the Area Under The Curve (EAA-AUC 0-240min) of plasma essential aminoacids levels.
Time Frame: At week 1 and week 2
Fasting EAA levels in plasma will be determined before consuming the products until 4 hours postprandially at 6 points after consuming the product (30 min., 60min., 90min., 120 min., 180 min., 240 min.). Plasma EAA will be quantified by liquid chromatography coupled to triple quadrupole mass spectrometry (LC-MS/MS).
Secondary Outcomes
- Bioavailability of total amino acids (TAA-AUC0-240 min) levels in plasma.(At week 1 and week 2)
- Bioavailability of non-essential amino acids (NEAA-AUC0-240 min) levels in plasma.(At week 1 and week 2)
- Bioavailability of branched chain amino acids (BCAA-AUC0-240min) levels in plasma.(At week 1 and week 2)
- Bioavailability of each of the essential amino acids individually (AUC0-240min) levels in plasma.(At week 1 and week 2)
- Time for maximum plasma concentration (Tmax)(At week 1 and week 2)
- Maximum plasma concentration (Cmax)(At week 1 and week 2)
- Insulinotropic response: Change in serum insulin levels (mU/L).(At week 1 and week 2)
- Insulinotropic response: Change in serum glucose levels (mg/dL).(At week 1 and week 2)
- Change of blood glucagon-like peptide-1 (GLP-1) levels (ng/mL).(At week 1 and week 2)
- Change of blood peptide YY (PPY) levels (pg/mL).(At week 1 and week 2)
- Change of blood ghrelin levels (pg/mL)(At week 1 and week 2)
- Modulation of subjective hunger(At week 1 and week 2)
- Modulation of subjective satiety(At week 1 and week 2)
- Modulation of subjective fullness.(At week 1 and week 2)
- Modulation of subjective desire to eat food.(At week 1 and week 2)
- Modulation of subjective desire to eat anything fatty, salty, sweet or tasty.(At week 1 and week 2)
- Expression of genes involved in inflammatory and oxidative metabolism(At week 1 and week 2)