- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05307159
Effect of a Bean Protein-added Supplement on Body Composition in High-performance Adolescent Athletes
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Yucatán
-
Mérida, Yucatán, Mexico, 97130
- Hospital Regional de Alta Especialidad de la Península de Yucatán
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: bean protein supplement
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
|
They will have a snack with bean protein for 21 days Participants will follow their usual diet, which will be quantified and evaluated.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Kilograms of muscle mass
Time Frame: 21 days
|
Muscle tissue in relation to total body weight and is estimated from body folds
|
21 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of fat Mass
Time Frame: 21 days
|
Fat mass is determined through panicle measurements using the ISAK method.
|
21 days
|
|
Kilograms of body weight
Time Frame: 21 days
|
Measured in kilograms, using the scale
|
21 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Azalia Ávila-Nava, Hospital Regional de Alta Especialidad de la Península de Yucatán
Publications and helpful links
General 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.
- Shenoy 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.
- Tang 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.
- Avila-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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2020-005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Athletes
-
PepsiCo Global R&DCompletedFluid Intake in Athletes | Sweating Rate in Athletes | Sweat Chloride Concentration in AthletesUnited States
-
Food and Nutrition Research Institute, PhilippinesPhilippine Council for Health Research & DevelopmentNot yet recruitingAthletes | Nutrition Physiology | The Focus of This Study is to Describe the Body Composition and Metabolism of Athletes and Non-athletes
-
Bozok UniversityThe Scientific Research Project Fund of Yozgat Bozok UniversityCompletedAthletes | Sports Performance | Visual-Motor Processing | Neuro-Psychophysiological Responses in AthletesTurkey (Türkiye)
-
University of BrasiliaNot yet recruiting
-
Universiti Putra MalaysiaNot yet recruiting
-
Hong Kong Metropolitan UniversityCompleted
-
São Paulo State UniversityCompleted
-
Dokuz Eylul UniversityRecruitingAthletes | VolleyballTurkey
-
University of PalermoUniversity of Urbino "Carlo Bo"CompletedAthletes | CyclistsItaly
Clinical Trials on bean protein supplement
-
University of ManitobaCompletedInsulin | Appetite | Faba Bean | Post-prandial Blood Glucose | Satiety HormonesCanada
-
University of TorontoActive, not recruiting
-
University of TorontoActive, not recruiting
-
Daniel MooreLesaffre InternationalRecruiting
-
Icahn School of Medicine at Mount SinaiCompletedGrowth in Premature InfantsUnited States
-
McMaster UniversityActive, not recruitingHealthy | Muscle Disuse AtrophyCanada
-
Örebro University, SwedenActive, not recruiting
-
The University of The West IndiesInternational Atomic Energy AgencyCompletedNutrition Deficiency Due to A Particular Kind of FoodJamaica
-
Texas Tech UniversityEHP LabsCompletedBody Weight Changes | Body Composition Changes | Anthropometric Changes | Metabolism Changes | Hemodynamic ChangesUnited States
-
USDA Grand Forks Human Nutrition Research CenterCompleted