Bone HealthMED-RES-BONENCT07584785
Mediterranean Diet and Progressive Resistance Training Effects on BMD and Bone Turnover in the Elderly
A study testing Mediterranean Diet combined with Resistance Training in people with Bone Health and Osteoporosis, run by University of Sfax at 1 site in Italy.
Trial summary
This randomized controlled trial was designed to investigate the effects of progressive resistance training (PRT) combined with a Mediterranean diet on bone mineral density (BMD) and bone turnover markers (BTMs) in older adults. Read more about this study
- Who is it for?
- Ages 65 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Health, Osteoporosis
- What is being tested?
- Mediterranean Diet combined with Resistance Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2024to 10 Mar 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 65 to 90 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Adults aged 65 years and older
- Ability to provide written informed consent
- Willingness to comply with study procedures and interventions
- Capability to participate in a supervised exercise program
Who cannot join
- Presence of metabolic bone diseases (e.g., osteoporosis requiring pharmacological treatment, Paget's disease, osteomalacia)
- Use of medications affecting bone metabolism, including systemic corticosteroids, bisphosphonates, hormone replacement therapy, selective estrogen receptor modulators, calcitonin, or parathyroid hormone analogs
- Uncontrolled cardiometabolic or respiratory conditions (e.g., uncontrolled hypertension, unstable angina, recent cardiovascular events within 6 months, severe chronic obstructive pulmonary disease, or poorly controlled diabetes)
- Severe musculoskeletal disorders or advanced osteoarthritis limiting safe exercise participation
- Neurological or psychiatric conditions affecting mobility or adherence
- Cognitive impairment (Mini-Mental State Examination score <24)
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- Recent fractures or major orthopedic surgery within the past 12 months
- Underweight (BMI <18.5 kg/m²) or severe frailty
- Severe renal or hepatic dysfunction (e.g., chronic kidney disease stage 4-5 or liver failure)
- Active malignancy or ongoing chemotherapy/radiotherapy
- Participation in another clinical trial within the previous 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mediterranean Diet and Progressive Resistance Training Effects on BMD and Bone Turnover in Elderly
This randomized controlled trial was designed to investigate the effects of progressive resistance training (PRT) combined with a Mediterranean diet on bone mineral density (BMD) and bone turnover markers (BTMs) in older adults.
Participants underwent a detailed medical history assessment, clinical examination, and dietary evaluation. Individuals who met the inclusion criteria provided written informed consent prior to participation. All procedures were conducted in accordance with the Declaration of Helsinki, and the study protocol was approved by the Ethics Committee of Manouba University (no. C.S. ISSEP.KS N˚040/2024).
Eligible participants were randomly allocated to either the experimental group (EXP; n = 22) or the control group (CON; n = 19). The intervention lasted 12 months. During this period, the EXP group participated in supervised PRT sessions combined with a Mediterranean diet intervention, while the CON group received no structured intervention.
Read the detailed description
Detailed Description
This randomized controlled trial was conducted to examine the effects of progressive resistance training (PRT) combined with a Mediterranean diet on bone mineral density (BMD) and bone turnover markers (BTMs) in older adults.
Participants were recruited and screened through a detailed medical history assessment, clinical examination, and dietary evaluation. Eligible individuals who met the inclusion criteria provided written informed consent before participation.
Participants were randomly assigned to either the experimental group (EXP; n = 22) or the control group (CON; n = 19). The intervention lasted 12 months. During this period, the experimental group participated in supervised progressive resistance training sessions combined with a Mediterranean diet intervention, while the control group received no structured intervention and maintained their usual lifestyle.
Bone mineral density and bone turnover markers were assessed at baseline and after the 12-month intervention period.
- Conditions
- Bone Health, Osteoporosis
- Being tested
- Mediterranean Diet combined with Resistance Training
- Keywords
- Mediterranean diet, resistance training, osteoporosis, aging, bone turnover markers, bone mineral density
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean Diet combined with Resistance TrainingBehavioural
Also called Mediterranean Diet and Supervised Resistance Training
Participants followed a Mediterranean diet and engaged in a supervised progressive resistance training program performed three times per week for 12 months. The training was progressively adapted based on individual capacity, focusing on major muscle groups using standard resistance exercises.
| Study group | Role | What they receive |
|---|---|---|
| Mediterranean Diet + Progressive Resistance Training | Experimental | Participants followed a Mediterranean diet combined with a supervised progressive resistance training program performed three times per week for 12 months. Receives: Behavioral: Mediterranean Diet combined with Resistance Training |
| Control Group | No intervention | No Structured Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Mineral Density (BMD)
Bone mineral density (BMD) was assessed using dual-energy X-ray absorptiometry (DXA) at the lumbar spine and femoral neck. Measurements were performed at baseline and after the 12-month intervention period. esults will be reported as BMD values expressed in g/cm².
Measured: Baseline and 12 months
Secondary outcomes (3)
Bone Formation Markers
Bone formation marker, osteocalcin were assessed in fasting blood samples. Unit of Measure: ng/mL
Measured: Baseline and 12 months
Bone Formation Markers
Bone-specific alkaline phosphatase (BAP) were assessed in fasting blood samples. Unit of Measure: U/L
Measured: Baseline and 12 months
Bone Formation Markers
Fasting serum P1NP concentrations will be assessed as a marker of bone formation. were assessed in fasting blood samples. Unit of Measure: ng/mL
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start1 Mar 2024
- Primary completion10 Mar 2025
- Study completion10 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone HealthStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1\) an intervention group receiving both a Mediterranean diet and supervised progressive resistance training, and (2) a control group receiving no structured intervention.
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sfax
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonella Muscella, University of Sfax
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07584785
- Sponsor's protocol ID
- C.S. ISSEP.KS N˚040/2024
- Acronym
- MED-RES-BONE
- Status last verified
- May 2026
- First submitted
- 6 May 2026
- Last updated
- 28 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mediterranean Diet and Progressive Resistance Training Effects on BMD and Bone Turnover in Elderly
- ClinicalTrials.gov ID
- NCT07584785
- Acronym / sponsor ID
- MED-RES-BONE / C.S. ISSEP.KS N˚040/2024
- Conditions
- Bone Health, Osteoporosis
- Keywords
- Mediterranean diet, resistance training, osteoporosis, aging, bone turnover markers, bone mineral density
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of SfaxUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 10 Mar 2025 (actual)
- Study completion
- 10 Mar 2025 (actual)
- First posted
- 13 May 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 randomized controlled trial was designed to investigate the effects of progressive resistance training (PRT) combined with a Mediterranean diet on bone mineral density (BMD) and bone turnover markers (BTMs) in older adults.
Participants underwent a detailed medical history assessment, clinical examination, and dietary evaluation. Individuals who met the inclusion criteria provided written informed consent prior to participation. All procedures were conducted in accordance with the Declaration of Helsinki, and the study protocol was approved by the Ethics Committee of Manouba University (no. C.S. ISSEP.KS N˚040/2024).
Eligible participants were randomly allocated to either the experimental group (EXP; n = 22) or the control group (CON; n = 19). The intervention lasted 12 months. During this period, the EXP group participated in supervised PRT sessions combined with a Mediterranean diet intervention, while the CON group received no structured intervention.
Detailed description
Detailed Description
This randomized controlled trial was conducted to examine the effects of progressive resistance training (PRT) combined with a Mediterranean diet on bone mineral density (BMD) and bone turnover markers (BTMs) in older adults.
Participants were recruited and screened through a detailed medical history assessment, clinical examination, and dietary evaluation. Eligible individuals who met the inclusion criteria provided written informed consent before participation.
Participants were randomly assigned to either the experimental group (EXP; n = 22) or the control group (CON; n = 19). The intervention lasted 12 months. During this period, the experimental group participated in supervised progressive resistance training sessions combined with a Mediterranean diet intervention, while the control group received no structured intervention and maintained their usual lifestyle.
Bone mineral density and bone turnover markers were assessed at baseline and after the 12-month intervention period.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1) an intervention group receiving both a Mediterranean diet and supervised progressive resistance training, and (2) a control group receiving no structured intervention.
| Arm | Type | Receives |
|---|---|---|
| Mediterranean Diet + Progressive Resistance Training | Experimental | Behavioral: Mediterranean Diet combined with Resistance TrainingParticipants followed a Mediterranean diet combined with a supervised progressive resistance training program performed three times per week for 12 months. |
| Control Group | No intervention | –No Structured Intervention |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Adults aged 65 years and older
- Ability to provide written informed consent
- Willingness to comply with study procedures and interventions
- Capability to participate in a supervised exercise program
Key exclusion criteria (11 listed)
- Presence of metabolic bone diseases (e.g., osteoporosis requiring pharmacological treatment, Paget's disease, osteomalacia)
- Use of medications affecting bone metabolism, including systemic corticosteroids, bisphosphonates, hormone replacement therapy, selective estrogen receptor modulators, calcitonin, or parathyroid hormone analogs
- Uncontrolled cardiometabolic or respiratory conditions (e.g., uncontrolled hypertension, unstable angina, recent cardiovascular events within 6 months, severe chronic obstructive pulmonary disease, or poorly controlled diabetes)
- Severe musculoskeletal disorders or advanced osteoarthritis limiting safe exercise participation
- Neurological or psychiatric conditions affecting mobility or adherence
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 |
|---|---|---|
| Mediterranean Diet combined with Resistance TrainingAlso: Mediterranean Diet and Supervised Resistance TrainingParticipants followed a Mediterranean diet and engaged in a supervised progressive resistance training program performed three times per week for 12 months. The training was progressively adapted based on individual capacity, focusing on major muscle groups using standard resistance exercises. | Behavioural | Mediterranean Diet + Progressive Resistance Training |
Primary outcome
Bone Mineral Density (BMD)
Time frame: Baseline and 12 months
Bone mineral density (BMD) was assessed using dual-energy X-ray absorptiometry (DXA) at the lumbar spine and femoral neck. Measurements were performed at baseline and after the 12-month intervention period. esults will be reported as BMD values expressed in g/cm².
3 secondary outcomes
Bone Formation Markers
Time frame: Baseline and 12 months
Bone Formation Markers
Time frame: Baseline and 12 months
Bone Formation Markers
Time frame: Baseline and 12 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 28 May 2026.
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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 Mediterranean Diet combined with Resistance Training in people with Bone Health and Osteoporosis, run by University of Sfax 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 4 inclusion and 11 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 28 May 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?
Bone Mineral Density (BMD) (time frame: Baseline and 12 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 28 May 2026.