NCT07315529

Brief Summary

This study investigates whether increasing legume consumption within a Mediterranean diet framework improves cellular hydration, autonomic regulation, and functional performance in competitive swimmers. Thirty-nine adolescent and young adult swimmers were monitored over a five-month competitive season under standardized training conditions. Participants were allocated to three groups according to habitual legume intake: a control group (\<1 serving/week, no dietary change), a moderate-intake group (≈2 servings/week increased to 3/week), and a high-intake group (≈3-4 servings/week increased to 6/week). Dietary counseling focused exclusively on adjusting legume intake, while overall training load and other dietary components were maintained. Primary outcomes include bioelectrical impedance-derived phase angle and body water distribution indices (extracellular water, intracellular water, ECW/ICW ratio) as markers of cellular health and hydration. Secondary outcomes include heart rate variability, cardiac coherence as indices of autonomic balance, and critical swim speed as a performance-related measure. The study aims to clarify whether a simple, sustainable increase in legume intake can support athletes' cellular integrity, autonomic function, and functional status without altering standard training programs.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 2, 2026

Completed
Last Updated

January 2, 2026

Status Verified

December 1, 2025

Enrollment Period

6 months

First QC Date

December 18, 2025

Last Update Submit

December 18, 2025

Conditions

Keywords

Mediterranean dietLegume consumptionCompetitive swimmersAthletesBioelectrical impedance analysisPhase angleExtracellular waterIntracellular waterHeart rate variabilityCritical swim speed

Outcome Measures

Primary Outcomes (1)

  • Change in phase angle (degrees)

    Phase angle derived from whole-body bioelectrical impedance analysis, reflecting cellular integrity and body cell mass. Measured at baseline and after 5 months in each arm.

    Baseline and 5 months

Secondary Outcomes (2)

  • Change in extracellular water percentage (ECW)

    Baseline and 5 months

  • Change in ECW/ICW ratio

    Baseline and 5 months

Study Arms (3)

3-Legumes

EXPERIMENTAL

Competitive swimmers increasing legume intake to 3 servings per week while maintaining usual diet and training load.

Other: Legume-enriched Mediterranean diet

6-Legumes

EXPERIMENTAL

Competitive swimmers increasing legume intake to 6 servings per week while maintaining usual diet and training load.

Other: Legume-enriched Mediterranean diet

Control

NO INTERVENTION

Competitive swimmers with habitual legume intake \<1 serving/week, receiving no prescribed change in legume consumption.

Interventions

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.

3-Legumes6-Legumes

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Competitive swimmers training at least six sessions per week.
  • 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.

You may not qualify if:

  • Current use of performance-enhancing drugs or any chronic medication.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Raffaele Open University

Roma, RM, 00141, Italy

Location

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Parallel-group interventional study with three diet-based arms: control group with no change in legume intake, moderate-intake group increasing to 3 servings/week, and high-intake group increasing to 6 servings/week, under standardized training conditions.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor

Study Record Dates

First Submitted

December 18, 2025

First Posted

January 2, 2026

Study Start

February 1, 2025

Primary Completion

July 31, 2025

Study Completion

July 31, 2025

Last Updated

January 2, 2026

Record last verified: 2025-12

Locations