Evaluation of Amino Acids Bioavailability in a Food Product Based on a Vegetable Protein Combination

NCT06774911 | Completed

• 1 other identifier: BIODISPROT
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Biological Availability; Bioavailability and AUC

Keywords

vegetal proteins; Inflammation; Satiety; Hunger; Amino acids

Outcome Measures

Primary Outcomes (1)

• Bioavailability of essential aminoacids calculated by the Area Under The Curve (EAA-AUC 0-240min) of plasma essential aminoacids levels.

  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).

  At week 1 and week 2

Secondary Outcomes (17)

• 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

Study Arms (2)

Protein from rice and pea (YUIT)

EXPERIMENTAL

Participants will receive 100g of powdered product with a complete and balanced nutritional profile with pea and rice protein source + 500 mL of water.

Other: YUIT

Protein from soy (P_PS)

ACTIVE COMPARATOR

Participants will receive 94.5 g of powdered product with a complete and balanced nutritional profile (the same as the YUIT product) with soy protein source + 500 mL of water

Other: P_PS

Interventions

YUIT OTHER

Product with protein source from pea and rice.

Protein from rice and pea (YUIT)

P_PS OTHER

Product with protein source from soy protein.

Protein from soy (P_PS)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Present values of body mass index (BMI) ≤ 18kg/m\^2 or ≥ 30 kg/m\^2.
• 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.

Sponsors & Collaborators

• Fundació Eurecat: lead
• ANFACO-CECOPESCA: collaborator

Study Sites (1)

Eurecat

Reus, Spain, 43204, Spain

Location

Related Links

• Technological Centre of Nutrition and Health. Eurecat\_Reus.

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Antoni Caimari PhD

  Fundació Eurecat

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Crossover Assignment Crossover, Randomized, Double-Blind Study

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 14, 2025
• Study Start: December 18, 2024
• Primary Completion: March 4, 2025
• Study Completion: March 4, 2025
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)