Legume-Enriched Mediterranean Diet and Cellular Hydration in Competitive Swimmers
NCT ID: NCT07315529
Last Updated: 2026-01-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
39 participants
INTERVENTIONAL
2025-02-01
2025-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Reproducibility of Acute Caffeine Effect
NCT06606639
Nutritional Supplements and Nitric Oxide Bioactivity
NCT03625596
Caffeine, Resistance Exercise and Muscle/Cerebral Oxygenation
NCT07001176
Iron Metabolism in Dragon Boat Athletes
NCT01431118
Caffeine, Resistance Exercise and EMG
NCT06606652
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
At baseline, participants completed an online dietary assessment using the validated MEDI-LITE questionnaire to quantify adherence to the Mediterranean diet and habitual legume intake. Based on baseline legume consumption, swimmers were assigned to one of three groups: a control group (\<1 serving/week, no change in diet), a moderate-intake group (≈2 servings/week increased to 3 servings/week), and a high-intake group (≈3-4 servings/week increased to 6 servings/week). A qualified nutrition professional provided counseling to adjust only legume intake, while other aspects of diet were kept stable. Dietary adherence and legume consumption were monitored regularly throughout the study, and the MEDI-LITE questionnaire was repeated at the end of the intervention.
The primary endpoints are phase angle and hydration indices derived from bioelectrical impedance analysis, including extracellular water (ECW), intracellular water (ICW), and the ECW/ICW ratio, which are considered integrated markers of cellular integrity, cell mass, and fluid compartmentalization. Secondary endpoints include measures of autonomic function-heart rate variability and cardiac coherence-assessed with a standardized device, and a critical swim speed test performed in an indoor pool as a functional performance indicator. Anthropometric data and basic clinical information were also collected.
The study was approved by the Lazio Area 5 Territorial Ethics Committee (Approval Code: N.57/SR/23) and conducted in accordance with the Declaration of Helsinki; all participants provided written informed consent before enrollment. By focusing on a feasible dietary modification (greater legume intake) within an otherwise stable Mediterranean-style eating pattern and unchanged training load, the study is designed to generate sport-specific evidence on whether plant-based protein sources such as legumes can enhance cellular hydration, autonomic regulation, and performance-related parameters in competitive athletes.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
3-Legumes
Competitive swimmers increasing legume intake to 3 servings per week while maintaining usual diet and training load.
Legume-enriched Mediterranean diet
Adjustment of habitual legume intake within a Mediterranean diet pattern to 3 or 6 servings per week, without altering other dietary components or training regimen.
6-Legumes
Competitive swimmers increasing legume intake to 6 servings per week while maintaining usual diet and training load.
Legume-enriched Mediterranean diet
Adjustment of habitual legume intake within a Mediterranean diet pattern to 3 or 6 servings per week, without altering other dietary components or training regimen.
Control
Competitive swimmers with habitual legume intake \<1 serving/week, receiving no prescribed change in legume consumption.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Legume-enriched Mediterranean diet
Adjustment of habitual legume intake within a Mediterranean diet pattern to 3 or 6 servings per week, without altering other dietary components or training regimen.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age ≥18 years.
* Ability to complete an online questionnaire in Italian prior to the first clinical evaluation.
* Willingness to comply with the prescribed legume intake pattern for the assigned group.
* Provision of written informed consent.
Exclusion Criteria
* Musculoskeletal injury or medical conditions that could interfere with training or study assessments.
* Consumption of alcohol or caffeinated beverages within 15 hours before testing sessions.
* Inability or unwillingness to complete the scheduled assessments or to provide informed consent.
18 Years
30 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
San Raffaele Telematic University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Mauro Lombardo
Full Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
San Raffaele Open University
Roma, RM, Italy
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Lazio Area 5, N.57/SR/23
Identifier Type: OTHER
Identifier Source: secondary_id
LEGUMES-SWIM
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.