Diet HabitsLEGUMES-SWIMNCT07315529
Legume-Enriched Mediterranean Diet and Cellular Hydration in Competitive Swimmers
A study testing Legume-enriched Mediterranean diet in people with Diet Habits and Athlete, run by San Raffaele Telematic University at 1 site in Italy.
Trial summary
This study investigates whether increasing legume consumption within a Mediterranean diet framework improves cellular hydration, autonomic regulation, and functional performance in competitive swimmers. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet Habits, Athlete
- What is being tested?
- Legume-enriched Mediterranean diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2025to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Diet Habits, Athlete
- Being tested
- Legume-enriched Mediterranean diet
- Keywords
- Mediterranean diet, Legume consumption, Competitive swimmers, Athletes, Bioelectrical impedance analysis, Phase angle, Extracellular water, Intracellular water, Heart rate variability, Critical swim speed
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Legume-enriched Mediterranean dietOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 3-Legumes | Experimental | Competitive swimmers increasing legume intake to 3 servings per week while maintaining usual diet and training load. Receives: 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. Receives: Other: Legume-enriched Mediterranean diet |
| Control | No intervention | Competitive swimmers with habitual legume intake <1 serving/week, receiving no prescribed change in legume consumption. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 5 months
Secondary outcomes (2)
Change in extracellular water percentage (ECW)
Extracellular water percentage obtained from bioelectrical impedance analysis, used as an index of fluid distribution.
Measured: Baseline and 5 months
Change in ECW/ICW ratio
Ratio between extracellular and intracellular water derived from bioelectrical impedance analysis, indicating body water compartmentalization.
Measured: Baseline and 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start1 Feb 2025
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet HabitsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Raffaele Telematic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mauro Lombardo, San Raffaele Telematic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07315529
- Sponsor's protocol ID
- LEGUMES-SWIM
- Other IDs
- Lazio Area 5, N.57/SR/23
- Acronym
- LEGUMES-SWIM
- Status last verified
- Dec 2025
- First submitted
- 18 Dec 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07315529
- Acronym / sponsor ID
- LEGUMES-SWIM / LEGUMES-SWIM
- Conditions
- Diet Habits, Athlete
- Keywords
- Mediterranean diet, Legume consumption, Competitive swimmers, Athletes, Bioelectrical impedance analysis, Phase angle, Extracellular water, Intracellular water
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- San Raffaele Telematic UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 2 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 3-Legumes | Experimental | Other: Legume-enriched Mediterranean dietCompetitive swimmers increasing legume intake to 3 servings per week while maintaining usual diet and training load. |
| 6-Legumes | Experimental | Other: Legume-enriched Mediterranean dietCompetitive swimmers increasing legume intake to 6 servings per week while maintaining usual diet and training load. |
| Control | No intervention | –Competitive swimmers with habitual legume intake <1 serving/week, receiving no prescribed change in legume consumption. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Legume-enriched Mediterranean dietAdjustment of habitual legume intake within a Mediterranean diet pattern to 3 or 6 servings per week, without altering other dietary components or training regimen. | Other | 3-Legumes, 6-Legumes |
Primary outcome
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.
2 secondary outcomes
Change in extracellular water percentage (ECW)
Time frame: Baseline and 5 months
Change in ECW/ICW ratio
Time frame: Baseline and 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Legume-enriched Mediterranean diet in people with Diet Habits and Athlete, run by San Raffaele Telematic University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in phase angle (degrees) (time frame: Baseline and 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.