- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07315529
Legume-Enriched Mediterranean Diet and Cellular Hydration in Competitive Swimmers (LEGUMES-SWIM)
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
RM
-
Roma, RM, Italy, 00141
- San Raffaele Open University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
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
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 (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
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)?
IPD Plan Description
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.
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