Legume-Enriched Mediterranean Diet and Cellular Hydration in Competitive Swimmers

NCT ID: NCT07315529

Last Updated: 2026-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-01

Study Completion Date

2025-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diet Habits Athlete

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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3-Legumes

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

Group Type EXPERIMENTAL

Legume-enriched Mediterranean diet

Intervention Type OTHER

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.

Group Type EXPERIMENTAL

Legume-enriched Mediterranean diet

Intervention Type OTHER

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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San Raffaele Telematic University

OTHER

Sponsor Role lead

Responsible Party

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Mauro Lombardo

Full Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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San Raffaele Open University

Roma, RM, Italy

Site Status

Countries

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Italy

Other Identifiers

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Lazio Area 5, N.57/SR/23

Identifier Type: OTHER

Identifier Source: secondary_id

LEGUMES-SWIM

Identifier Type: -

Identifier Source: org_study_id

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