Biological AvailabilityBIODISPROTNCT06774911
Evaluation of Amino Acids Bioavailability in a Food Product Based on a Vegetable Protein Combination
A study testing YUIT and P_PS in people with Biological Availability and Bioavailability and AUC, run by Fundació Eurecat at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Biological Availability, Bioavailability and AUC
- What is being tested?
- YUIT and P_PS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSpain
- Study dates
- 18 Dec 2024to 4 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 18Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Amino Acids Bioavailability in a Food Product Based on a Vegetable Protein Combination: A Randomized, Double-blind Crossover Study
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.
Read the 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.
The secondary objectives of the study are to compare the following kinetic parameters and the metabolic response of the two products with different plant-based protein sources.
- Bioavailability of AAT (AAT-AUC0-240min), AANE (AANE-AUC0-240min), BCAA (BCAA-AUC0-240min) and of each of the EAA individually (EAA-AUC0-240min).
- Time to reach maximum concentration of AAT (AAT-Tmax), AAE (AAE-Tmax), AANE (AANE-Tmax), BCAA (BCAA-Tmax) and of each EAA individually.
- Maximum concentration of AAT (AAT-CMax), AAE (AAE-CMax), AANE (AANE-CMax), BCAA (BCAA-CMax) and of each EAA individually.
- Insulinotropic response: insulin and blood glucose levels.
- Objective hunger and satiety modulation: blood levels of hunger and satiety regulating hormones: glucagon-like peptide-1 (GLP-1), peptide YY (PPY), ghrelin.
- Modulation of hunger and subjective satiety.
- Changes in the expression of genes involved in oxidative and inflammatory metabolism.
During the study there will be 3 visits: a preselection visit (V0), a visit for the first postprandial study (V1) and after one week washing period, a visit for the second postprandial study (V2).
- Conditions
- Biological Availability, Bioavailability and AUC
- Being tested
- YUIT, P_PS
- Keywords
- vegetal proteins, Inflammation, Satiety, Hunger, Amino acids
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YUITOther
Product with protein source from pea and rice.
P_PSOther
Product with protein source from soy protein.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: P_PS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At week 1 and week 2
Secondary outcomes (17)
Bioavailability of total amino acids (TAA-AUC0-240 min) levels in plasma.
Fasting TAA levels in plasma will be determined before consuming the product until 4 hours postprandially at 6 points after consuming the product ( 30 min., 60min., 90 min., 120 min., 180 min., 240 min.).
Plasma TAA will be quantified by liquid chromatography coupled to triple quadrupole mass spectrometry (LC-MS/MS).
Measured: At week 1 and week 2
Bioavailability of non-essential amino acids (NEAA-AUC0-240 min) levels in plasma.
Fasting NEAA levels in plasma will be determined before consuming the product until 4 hours postprandially at 6 points after consuming the product (30 min., 60min., 90 min., 120 min., 180 min., 240 min.).
Plasma NEAA will be quantified by liquid chromatography coupled to triple quadrupole mass spectrometry (LC-MS/MS).
Measured: At week 1 and week 2
Bioavailability of branched chain amino acids (BCAA-AUC0-240min) levels in plasma.
Fasting BCAA levels in plasma will be determined before consuming the product until 4 hours postprandially at 6 points after consuming the product ( 30 min., 60min., 90 min., 120 min., 180 min., 240 min.).
Plasma BCAA will be quantified by liquid chromatography coupled to triple quadrupole mass spectrometry (LC-MS/MS).
Measured: At week 1 and week 2
Bioavailability of each of the essential amino acids individually (AUC0-240min) levels in plasma.
Fasting each essential aminoacids levels in plasma will be determined before consuming the product until 4 hours postprandially at 6 points after consuming the product ( 30 min., 60min., 90 min., 120 min., 180 min., 240 min.).
Plasma each essential aminoacids levels will be quantified by liquid chromatography coupled to triple quadrupole mass spectrometry (LC-MS/MS).
Measured: At week 1 and week 2
Time for maximum plasma concentration (Tmax)
Time period for the maximum plasma concentration of TAA, NEAA, BCAA and each essential aminoacids
Measured: At week 1 and week 2
Maximum plasma concentration (Cmax)
Maximum plasma concentration of TAA, NEAA, BCAA and each essential aminoacids.
Measured: At week 1 and week 2
Insulinotropic response: Change in serum insulin levels (mU/L).
Fasting insulin levels in serum will be determined before consuming the product until 3 hours postprandially at 7 points after consuming the product (15min., 30min., 45min., 60min., 90min., 120min. and 180min.) Insulin levels will be measured by standardized chemiluminescence methods.
Measured: At week 1 and week 2
Insulinotropic response: Change in serum glucose levels (mg/dL).
Fasting glucose levels in serum will be determined before consuming the product until 3 hours postprandially at 7 points after consuming the product (15min., 30min., 45min., 60min., 90min., 120min. and 180min.) Serum glucose levels will be determined by standardized spectrophotometry methods.
Measured: At week 1 and week 2
Change of blood glucagon-like peptide-1 (GLP-1) levels (ng/mL).
Levels of blood GLP-1, will be measured by standardized chemiluminescence methods at extraction points: 0min., 30min., 60min., 120min., 180min. and 240 min.
Measured: At week 1 and week 2
Change of blood peptide YY (PPY) levels (pg/mL).
Levels of blood PPY, will be measured by standardized chemiluminescence methods at extraction points: 0min., 30min., 60min., 120min., 180min. and 240 min.
Measured: At week 1 and week 2
Change of blood ghrelin levels (pg/mL)
Levels of blood ghrelin will be measured by standardized chemiluminescence methods at extraction points: 0min., 30min., 60min., 120min., 180min. and 240 min.
Measured: At week 1 and week 2
Modulation of subjective hunger
The evaluation of the sensation of subjective hunger will be assessed by using a 100 mm Visual Analogue Scale (VAS) at the following points: 0 min (baseline time), 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 180 and 240 min.
The VAS is presented as a horizontal line 100 mm long, with two ends that represent the limits of the phenomenon to be evaluated: One end of the line is labeled "No hunger" (0), while the other end is marked as "extreme hunger" (100). The volunteer is asked to mark on the line the point that best represents the intensity of what he or she is feeling at that moment. The mark made is measured in millimeters from the bottom end (zero), and the value obtained is the quantitative representation of the phenomenon evaluated.
Measured: At week 1 and week 2
Modulation of subjective satiety
The evaluation of the sensation of subjective satiety will be assessed by using a 100 mm Visual Analogue Scale (VAS) at the following points: 0 min (baseline time), 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 180 and 240 min.
The VAS is presented as a horizontal line 100 mm long, with two ends that represent the limits of the phenomenon to be evaluated: One end of the line is labeled "not at all satisfied" (0), while the other end is marked as "totally satisfied" (100). The volunteer is asked to mark on the line the point that best represents the intensity of what he or she is feeling at that moment. The mark made is measured in millimeters from the bottom end (zero), and the value obtained is the quantitative representation of the phenomenon evaluated.
Measured: At week 1 and week 2
Modulation of subjective fullness.
The evaluation of the sensation of subjective fullnes will be assessed by using a 100 mm Visual Analogue Scale (VAS) at the following points: 0 min (baseline time), 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 180 and 240 min.
The VAS is presented as a horizontal line 100 mm long, with two ends that represent the limits of the phenomenon to be evaluated: One end of the line is labeled "no feeling of fullness" (0), while the other end is marked as "I have the greatest feeling of fullness I have ever had" (100). The volunteer is asked to mark on the line the point that best represents the intensity of what he or she is feeling at that moment. The mark made is measured in millimeters from the bottom end (zero), and the value obtained is the quantitative representation of the phenomenon evaluated.
Measured: At week 1 and week 2
Modulation of subjective desire to eat food.
The evaluation of the sensation of subjective fullnes will be assessed by using a 100 mm Visual Analogue Scale (VAS) at the following points: 0 min (baseline time), 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 180 and 240 min.
The VAS is presented as a horizontal line 100 mm long, with two ends that represent the limits of the phenomenon to be evaluated: One end of the line is labeled "I have no desire to eat food" (0), while the other end is marked as "I have the greatest desire to eat any food" (100). The volunteer is asked to mark on the line the point that best represents the intensity of what he or she is feeling at that moment. The mark made is measured in millimeters from the bottom end (zero), and the value obtained is the quantitative representation of the phenomenon evaluated.
Measured: At week 1 and week 2
Modulation of subjective desire to eat anything fatty, salty, sweet or tasty.
The evaluation of the sensation of subjective desire to eat anything fatty, salty, sweet or tasty.will be assessed by using a 100 mm Visual Analogue Scale (VAS) at the following points: 0 min (baseline time), 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 180 and 240 min.
The VAS is presented as a horizontal line 100 mm long, with two ends that represent the limits of the phenomenon to be evaluated: One end of the line is labeled "I have no desire to eat anything fatty, salty, sweet or tasty" (0), while the other end is marked as "I have the greatest desire to eat anything fatty, salty, sweet or tasty" (100). The volunteer is asked to mark on the line the point that best represents the intensity of what he or she is feeling at that moment. The mark made is measured in millimeters from the bottom end (zero), and the value obtained is the quantitative representation of the phenomenon evaluated.
Measured: At week 1 and week 2
Expression of genes involved in inflammatory and oxidative metabolism
Changes in gene expression of genes involved in oxidative and inflammatory pathways will be quantified by transcriptomics of blood samples at baseline and at 240 min.
Measured: At week 1 and week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start18 Dec 2024
- Primary completion4 Mar 2025
- Study completion4 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biological AvailabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover Assignment Crossover, Randomized, Double-Blind Study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundació Eurecat
- Sponsor type
- University, hospital or other
- Collaborators
- ANFACO-CECOPESCA
- Responsible party
- Sponsor
- Investigators
- Antoni Caimari PhD, Principal investigator, Fundació Eurecat
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06774911
- Sponsor's protocol ID
- BIODISPROT
- Acronym
- BIODISPROT
- Status last verified
- Mar 2025
- First submitted
- 9 Jan 2025
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Amino Acids Bioavailability in a Food Product Based on a Vegetable Protein Combination: A Randomized, Double-blind Crossover Study
- ClinicalTrials.gov ID
- NCT06774911
- Acronym / sponsor ID
- BIODISPROT / BIODISPROT
- Conditions
- Biological Availability, Bioavailability and AUC
- Keywords
- vegetal proteins, Inflammation, Satiety, Hunger, Amino acids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Fundació EurecatUniversity, hospital or other
- Collaborators
- ANFACO-CECOPESCA
- Study start
- 18 Dec 2024 (actual)
- Primary completion
- 4 Mar 2025 (actual)
- Study completion
- 4 Mar 2025 (actual)
- First posted
- 14 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
The secondary objectives of the study are to compare the following kinetic parameters and the metabolic response of the two products with different plant-based protein sources.
- Bioavailability of AAT (AAT-AUC0-240min), AANE (AANE-AUC0-240min), BCAA (BCAA-AUC0-240min) and of each of the EAA individually (EAA-AUC0-240min).
- Time to reach maximum concentration of AAT (AAT-Tmax), AAE (AAE-Tmax), AANE (AANE-Tmax), BCAA (BCAA-Tmax) and of each EAA individually.
- Maximum concentration of AAT (AAT-CMax), AAE (AAE-CMax), AANE (AANE-CMax), BCAA (BCAA-CMax) and of each EAA individually.
- Insulinotropic response: insulin and blood glucose levels.
- Objective hunger and satiety modulation: blood levels of hunger and satiety regulating hormones: glucagon-like peptide-1 (GLP-1), peptide YY (PPY), ghrelin.
- Modulation of hunger and subjective satiety.
- Changes in the expression of genes involved in oxidative and inflammatory metabolism.
During the study there will be 3 visits: a preselection visit (V0), a visit for the first postprandial study (V1) and after one week washing period, a visit for the second postprandial study (V2).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Crossover Assignment Crossover, Randomized, Double-Blind Study
| Arm | Type | Receives |
|---|---|---|
| Protein from rice and pea (YUIT) | Experimental | Other: YUITParticipants will receive 100g of powdered product with a complete and balanced nutritional profile with pea and rice protein source + 500 mL of water. |
| Protein from soy (P_PS) | Active comparator | Other: P_PSParticipants 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YUITProduct with protein source from pea and rice. | Other | Protein from rice and pea (YUIT) |
| P_PSProduct with protein source from soy protein. | Other | Protein from soy (P_PS) |
Primary outcome
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).
17 secondary outcomes
Bioavailability of total amino acids (TAA-AUC0-240 min) levels in plasma.
Time frame: At week 1 and week 2
Bioavailability of non-essential amino acids (NEAA-AUC0-240 min) levels in plasma.
Time frame: At week 1 and week 2
Bioavailability of branched chain amino acids (BCAA-AUC0-240min) levels in plasma.
Time frame: At week 1 and week 2
Bioavailability of each of the essential amino acids individually (AUC0-240min) levels in plasma.
Time frame: At week 1 and week 2
Time for maximum plasma concentration (Tmax)
Time frame: At week 1 and week 2
Maximum plasma concentration (Cmax)
Time frame: At week 1 and week 2
Insulinotropic response: Change in serum insulin levels (mU/L).
Time frame: At week 1 and week 2
Insulinotropic response: Change in serum glucose levels (mg/dL).
Time frame: At week 1 and week 2
Change of blood glucagon-like peptide-1 (GLP-1) levels (ng/mL).
Time frame: At week 1 and week 2
Change of blood peptide YY (PPY) levels (pg/mL).
Time frame: At week 1 and week 2
Change of blood ghrelin levels (pg/mL)
Time frame: At week 1 and week 2
Modulation of subjective hunger
Time frame: At week 1 and week 2
Modulation of subjective satiety
Time frame: At week 1 and week 2
Modulation of subjective fullness.
Time frame: At week 1 and week 2
Modulation of subjective desire to eat food.
Time frame: At week 1 and week 2
Modulation of subjective desire to eat anything fatty, salty, sweet or tasty.
Time frame: At week 1 and week 2
Expression of genes involved in inflammatory and oxidative metabolism
Time frame: At week 1 and week 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Technological Centre of Nutrition and Health. Eurecat\_Reus.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoni Caimari PhD principal investigator
Fundació Eurecat
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing YUIT and P_PS in people with Biological Availability and Bioavailability and AUC, run by Fundació Eurecat at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.