TeenagersNCT05307159
Effect of a Bean Protein-added Supplement on Body Composition in High-performance Adolescent Athletes
A study testing bean protein supplement in people with Teenagers and Athletes, run by Hospital Regional de Alta Especialidad de la Península de Yucatán at 1 site in Mexico.
Trial summary
Background: Sport is a specialized competitive physical activity that is regulated and requires daily physical training. The workouts allow athletes to increase strength, endurance exercise performance, and muscle mass. Read more about this study
- Who is it for?
- Ages 11 to 18 yearsHealthy volunteers can take part
- What is being tested?
- bean protein supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteMexico
- Study dates
- 2 May 2022to 1 Aug 2022
- 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 11 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Athletes who play table tennis
- Age between 11 and 18 years
- Male and female
- Signature of informed consent by parents or guardians
- Approval of the informed assent by the minor under 18 years of age
Who cannot join
- High-performance athletes who are injured
- Athletes who are not carrying out a quantified diet
- Athletes who present any pathology and/or consume any medication
- Athlete who consumes another nutritional supplement
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Regional de Alta Especialidad de la Península de Yucatán
Mérida, Yucatán, 97130
About this study
Official title: Effect of a Bean (Phaseolus Vulgaris L.) Protein-added Supplement on Body Composition in High-performance Adolescent Athletes: a Pilot Study
Background: Sport is a specialized competitive physical activity that is regulated and requires daily physical training. The workouts allow athletes to increase strength, endurance exercise performance, and muscle mass. Due to this, it is extremely important to consider that high-performance athletes require a meal plan with a higher energy requirement compared to a normal person who does not perform high-intensity activity. The diet of these athletes needs higher protein requirements to support the accumulation and/or maintenance of lean mass. Specifically athletes between 4 to 17 years of age, the protein requirement is of utmost importance to maintain muscle mass between 68-73%. Therefore, the recommendations for protein intake for athletes in this age range is approximately between 10 and 30% of the total energy intake. One of the strategies that has been used is supplementation with protein isolates, since in this way there is greater protein accessibility to maintain a balance between protein synthesis and degradation. The main protein supplements that are currently consumed come from proteins of animal origin; however, these usually have high costs, which makes them difficult to access for the population. Due to this, strategies have begun to be sought through the use of different proteins to generate similar effects.
Objective: To evaluate the effect of a bean protein supplement on body composition in high-performance adolescent athletes.
Methodology: The protocol will be divided into two stages, in the first one a supplement added with bean protein will be elaborated. First, the extraction of protein from the bean will be carried out, then it will be subjected to a heat treatment to eliminate anti-nutrients and finally its chemical composition will be analyzed. In the second stage, a pilot study will be carried out to evaluate the effect of the bean protein supplement in high-performance adolescent athletes. High-performance table tennis athletes, adolescents who agree to collaborate with the study will be included. Bean protein supplementation will be for 21 continuous days in the athletes' snack. Anthropometric measurements will be taken at the beginning and at the end of the intervention. A control of the diet and supplementation of the athletes will be carried out with the support of their coaches.
Read the detailed description
The protocol will include high-performance table tennis athletes, adolescents who are a minimum of 11 years old and a maximum of 18 years and 11 months who have the consent of their parents and/or guardians and the assent signed by them. Bean protein supplementation will be a mesocycle of 21 continuous days. The supplement will be consumed daily during these 21 days in the athletes' snack. Anthropometric measurements will be taken at the beginning and at the end of the intervention. Their usual diet and adherence to the supplementation of the athletes will be evaluated.
- Being tested
- bean protein supplement
- Keywords
- teenagers, bean, supplement, muscle mass, sporty
- Medical subject headings
- Spinocerebellar Ataxia 31
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bean protein supplementDietary supplement
They will have a snack with bean protein for 21 days Participants will follow their usual diet, which will be quantified and evaluated.
| Study group | Role | What they receive |
|---|---|---|
| bean protein supplement | Experimental | The supplement will be consumed daily for 21 days in the athletes' snack, the supplement contains 7 g of bean protein mixed in 60 mL of milk and 60 mL of strawberry drinkable yogurt Receives: Dietary Supplement: bean protein supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kilograms of muscle mass
Muscle tissue in relation to total body weight and is estimated from body folds
Measured: 21 days
Secondary outcomes (2)
Percentage of fat Mass
Fat mass is determined through panicle measurements using the ISAK method.
Measured: 21 days
Kilograms of body weight
Measured in kilograms, using the scale
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start2 May 2022
- Primary completion4 Jul 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for TeenagersStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Regional de Alta Especialidad de la Península de Yucatán
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Azalia Avila Nava, PhD, Hospital Regional de Alta Especialidad de la Península de Yucatán
- Investigators
- Azalia Ávila-Nava, Principal investigator, Hospital Regional de Alta Especialidad de la Península de Yucatán
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05307159
- Sponsor's protocol ID
- 2020-005
- Status last verified
- Jun 2022
- First submitted
- 23 Mar 2022
- Last updated
- 2 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nemet D, Eliakim A. Pediatric sports nutrition: an update. Curr Opin Clin Nutr Metab Care. 2009 May;12(3):304-9. doi: 10.1097/MCO.0b013e32832a215b.
PubMed 19337125Shenoy S, Dhawan M, Singh Sandhu J. Four Weeks of Supplementation With Isolated Soy Protein Attenuates Exercise-Induced Muscle Damage and Enhances Muscle Recovery in Well Trained Athletes: A Randomized Trial. Asian J Sports Med. 2016 May 23;7(3):e33528. doi: 10.5812/asjsm.33528. eCollection 2016 Sep.
PubMed 27826398Tang JE, Moore DR, Kujbida GW, Tarnopolsky MA, Phillips SM. Ingestion of whey hydrolysate, casein, or soy protein isolate: effects on mixed muscle protein synthesis at rest and following resistance exercise in young men. J Appl Physiol (1985). 2009 Sep;107(3):987-92. doi: 10.1152/japplphysiol.00076.2009. Epub 2009 Jul 9.
PubMed 19589961Avila-Nava A, Noriega LG, Tovar AR, Granados O, Perez-Cruz C, Pedraza-Chaverri J, Torres N. Food combination based on a pre-hispanic Mexican diet decreases metabolic and cognitive abnormalities and gut microbiota dysbiosis caused by a sucrose-enriched high-fat diet in rats. Mol Nutr Food Res. 2017 Jan;61(1). doi: 10.1002/mnfr.201501023. Epub 2016 Aug 8.
PubMed 27352915
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Bean (Phaseolus Vulgaris L.) Protein-added Supplement on Body Composition in High-performance Adolescent Athletes: a Pilot Study
- ClinicalTrials.gov ID
- NCT05307159
- Acronym / sponsor ID
- 2020-005
- Keywords
- teenagers, bean, supplement, muscle mass, sporty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Hospital Regional de Alta Especialidad de la Península de YucatánUniversity, hospital or other
- Study start
- 2 May 2022 (actual)
- Primary completion
- 4 Jul 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 1 Apr 2022 (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.
Background: Sport is a specialized competitive physical activity that is regulated and requires daily physical training. The workouts allow athletes to increase strength, endurance exercise performance, and muscle mass. Due to this, it is extremely important to consider that high-performance athletes require a meal plan with a higher energy requirement compared to a normal person who does not perform high-intensity activity. The diet of these athletes needs higher protein requirements to support the accumulation and/or maintenance of lean mass. Specifically athletes between 4 to 17 years of age, the protein requirement is of utmost importance to maintain muscle mass between 68-73%. Therefore, the recommendations for protein intake for athletes in this age range is approximately between 10 and 30% of the total energy intake. One of the strategies that has been used is supplementation with protein isolates, since in this way there is greater protein accessibility to maintain a balance between protein synthesis and degradation. The main protein supplements that are currently consumed come from proteins of animal origin; however, these usually have high costs, which makes them difficult to access for the population. Due to this, strategies have begun to be sought through the use of different proteins to generate similar effects.
Objective: To evaluate the effect of a bean protein supplement on body composition in high-performance adolescent athletes.
Methodology: The protocol will be divided into two stages, in the first one a supplement added with bean protein will be elaborated. First, the extraction of protein from the bean will be carried out, then it will be subjected to a heat treatment to eliminate anti-nutrients and finally its chemical composition will be analyzed. In the second stage, a pilot study will be carried out to evaluate the effect of the bean protein supplement in high-performance adolescent athletes. High-performance table tennis athletes, adolescents who agree to collaborate with the study will be included. Bean protein supplementation will be for 21 continuous days in the athletes' snack. Anthropometric measurements will be taken at the beginning and at the end of the intervention. A control of the diet and supplementation of the athletes will be carried out with the support of their coaches.
Detailed description
The protocol will include high-performance table tennis athletes, adolescents who are a minimum of 11 years old and a maximum of 18 years and 11 months who have the consent of their parents and/or guardians and the assent signed by them. Bean protein supplementation will be a mesocycle of 21 continuous days. The supplement will be consumed daily during these 21 days in the athletes' snack. Anthropometric measurements will be taken at the beginning and at the end of the intervention. Their usual diet and adherence to the supplementation of the athletes will be evaluated.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| bean protein supplement | Experimental | Dietary Supplement: bean protein supplementThe supplement will be consumed daily for 21 days in the athletes' snack, the supplement contains 7 g of bean protein mixed in 60 mL of milk and 60 mL of strawberry drinkable yogurt |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Athletes who play table tennis
- Age between 11 and 18 years
- Male and female
- Signature of informed consent by parents or guardians
- Approval of the informed assent by the minor under 18 years of age
Key exclusion criteria (4 listed)
- High-performance athletes who are injured
- Athletes who are not carrying out a quantified diet
- Athletes who present any pathology and/or consume any medication
- Athlete who consumes another nutritional supplement
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 |
|---|---|---|
| bean protein supplementThey will have a snack with bean protein for 21 days Participants will follow their usual diet, which will be quantified and evaluated. | Dietary supplement | bean protein supplement |
Primary outcome
Kilograms of muscle mass
Time frame: 21 days
Muscle tissue in relation to total body weight and is estimated from body folds
2 secondary outcomes
Percentage of fat Mass
Time frame: 21 days
Kilograms of body weight
Time frame: 21 days
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 2 Sep 2022.
- Background: PubMed 19337125Nemet D, Eliakim A. Pediatric sports nutrition: an update. Curr Opin Clin Nutr Metab Care. 2009 May;12(3):304-9. doi: 10.1097/MCO.0b013e32832a215b.
- Background: PubMed 27826398Shenoy S, Dhawan M, Singh Sandhu J. Four Weeks of Supplementation With Isolated Soy Protein Attenuates Exercise-Induced Muscle Damage and Enhances Muscle Recovery in Well Trained Athletes: A Randomized Trial. Asian J Sports Med. 2016 May 23;7(3):e33528. doi: 10.5812/asjsm.33528. eCollection 2016 Sep.
- Background: PubMed 19589961Tang JE, Moore DR, Kujbida GW, Tarnopolsky MA, Phillips SM. Ingestion of whey hydrolysate, casein, or soy protein isolate: effects on mixed muscle protein synthesis at rest and following resistance exercise in young men. J Appl Physiol (1985). 2009 Sep;107(3):987-92. doi: 10.1152/japplphysiol.00076.2009. Epub 2009 Jul 9.
- Background: PubMed 27352915Avila-Nava A, Noriega LG, Tovar AR, Granados O, Perez-Cruz C, Pedraza-Chaverri J, Torres N. Food combination based on a pre-hispanic Mexican diet decreases metabolic and cognitive abnormalities and gut microbiota dysbiosis caused by a sucrose-enriched high-fat diet in rats. Mol Nutr Food Res. 2017 Jan;61(1). doi: 10.1002/mnfr.201501023. Epub 2016 Aug 8.
- 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.
Azalia Ávila-Nava principal investigator
Hospital Regional de Alta Especialidad de la Península de Yucatán
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bean protein supplement in people with Teenagers and Athletes, run by Hospital Regional de Alta Especialidad de la Península de Yucatán at 1 site in Mexico.
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 4 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 2 Sep 2022. 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 Mexico. 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?
Kilograms of muscle mass (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05307159, which also lists 4 linked publications.
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 2 Sep 2022; AzTrials last refreshed its copy on 2 Nov 2026.