Legume-Enriched Mediterranean Diet and Cellular Hydration in Competitive Swimmers (LEGUMES-SWIM)

December 18, 2025 updated by: Mauro Lombardo, San Raffaele Telematic University

Legume Consumption Within a Mediterranean Diet Framework and Its Effects on Cellular Hydration, Autonomic Regulation, and Functional Performance in Competitive Swimmers: A Five-Month Intervention Study

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.

Study Overview

Status

Completed

Conditions

Detailed Description

This interventional study was conducted in competitive swimmers to evaluate the impact of higher legume consumption, within a Mediterranean diet framework, on markers of cellular health, body water distribution, autonomic regulation, and functional performance. Thirty-nine competitive swimmers (mean age approximately 20 years; both males and females) were enrolled and followed for five months during the first half of the competitive season. All athletes trained under similar standardized conditions, completing six weekly sessions that combined dry-land pre-activation, in-water training, and, in some sessions, gym-based strength work.

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.

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • RM
      • Roma, RM, Italy, 00141
        • San Raffaele Open University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 3-Legumes
Competitive swimmers increasing legume intake to 3 servings per week while maintaining usual diet and training load.
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.
Experimental: 6-Legumes
Competitive swimmers increasing legume intake to 6 servings per week while maintaining usual diet and training load.
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.
No Intervention: Control
Competitive swimmers with habitual legume intake <1 serving/week, receiving no prescribed change in legume consumption.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in phase angle (degrees)
Time Frame: Baseline and 5 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in extracellular water percentage (ECW)
Time Frame: Baseline and 5 months
Extracellular water percentage obtained from bioelectrical impedance analysis, used as an index of fluid distribution.
Baseline and 5 months
Change in ECW/ICW ratio
Time Frame: Baseline and 5 months
Ratio between extracellular and intracellular water derived from bioelectrical impedance analysis, indicating body water compartmentalization.
Baseline and 5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2025

Primary Completion (Actual)

July 31, 2025

Study Completion (Actual)

July 31, 2025

Study Registration Dates

First Submitted

December 18, 2025

First Submitted That Met QC Criteria

December 18, 2025

First Posted (Estimated)

January 2, 2026

Study Record Updates

Last Update Posted (Estimated)

January 2, 2026

Last Update Submitted That Met QC Criteria

December 18, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LEGUMES-SWIM
  • Lazio Area 5, N.57/SR/23 (Other Identifier: Lazio Area 5 Territorial Ethics Committee, Italy)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

At present, there is no finalized institutional policy or dedicated repository for sharing de-identified individual participant data for this study. The investigators may consider data sharing in the future upon development of appropriate governance procedures, data use agreements, and additional ethics committee approvals.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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