Sarcopenic ObesityNCT07030738
Plant vs Animal-based Protein Sources as an Anabolic and Metabolic-protective Options for SO in Older Adults
A study testing Legume-Based High-Protein Diet + Resistance Training, Meat-Based High-Protein Diet + Resistance Training and Mixed Legume and Meat High-Protein Diet + Resistance Training in people with Sarcopenic Obesity and Obesity and Obesity-related Medical Conditions, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
This study is testing how different types of protein - from red meat, legumes (like lentils and beans), or a mix of both - affect muscle strength, body composition, and metabolic health in older adults with obesity who are also at risk for sarcopenia (loss of muscle mass and function). Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Sarcopenic Obesity, Obesity and Obesity-related Medical Conditions, Obesity (Body Mass Index >30 kg/m2)
- What is being tested?
- Legume-Based High-Protein Diet + Resistance Training, Meat-Based High-Protein Diet + Resistance Training and Mixed Legume and Meat High-Protein Diet + Resistance Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2025to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 55 years or older.
- Diagnosed with obesity.
- At risk for sarcopenia, based on at least one of the following: Low score on the validated SARC-F-calf questionnaire (as suggested in prior studies). More than one comorbidity associated with sarcopenic obesity (e.g., diabetes, osteoporosis, cardiovascular disease, etc.). Polypharmacy: taking 8 or more prescribed medications. Evidence of strength or functional impairment, assessed using validated measurements at the baseline visit.
Who cannot join
- Recent use of steroid agents within the past 6 months (replacement therapy is allowed).
- Uncorrected hypothyroidism: TSH > 6 mIU/L.
- Diagnosis of malignancy within the past 5 years, except for non-melanoma skin cancer.
- Chronic kidney disease (CKD) at stage >1 (due to protein restriction needs).
- Recent (≤6 months) or unstable cardiovascular condition, or NYHA Class III or higher congestive heart failure.
- Currently performing resistance training.
Show all 10Show fewer
- Currently undergoing nutritional therapy, have recently changed diet (<1 month), or are enrolled in active weight-loss programs or therapies (including lifestyle and/or pharmacotherapy). Note: Patients stable on GLP-1 agonists or other pharmacotherapy are eligible.
- Vegetarians/vegans, or individuals with aversion or allergy to all legumes or all red meat products.
- Habitual consumption of more than 3 servings/week of either legumes or red meat.
- Other medical, psychiatric conditions, or lab abnormalities that may pose a risk to participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site
Tel Aviv Sourasky Medical Center
Tel Aviv, Tel Aviv, 6423906
Assaf Buch, Professor, +972 54-993-1033, buchasaf@gmail.com
About this study
Official title: Plant (Legumes) vs Animal-based (Meat) Protein Sources as an Anabolic and Metabolic-protective Options for Sarcopenic Obesity in Older Adults- A Randomized Controlled Trial
This study is testing how different types of protein - from red meat, legumes (like lentils and beans), or a mix of both - affect muscle strength, body composition, and metabolic health in older adults with obesity who are also at risk for sarcopenia (loss of muscle mass and function). Participants will follow a personalized weight loss diet with one high-protein meal each day that includes either red meat, legumes, or both, along with a home-based strength training program. The study will last three months and will include health assessments such as blood tests, muscle and fat measurements, and physical function tests. The goal is to find out which type of protein source is most helpful for improving strength, reducing body fat, and supporting healthy aging.
- Conditions
- Sarcopenic Obesity, Obesity and Obesity-related Medical Conditions, Obesity (Body Mass Index >30 kg/m2), Sarcopenia, Muscle Loss, Aging
- Being tested
- Legume-Based High-Protein Diet + Resistance Training, Meat-Based High-Protein Diet + Resistance Training, Mixed Legume and Meat High-Protein Diet + Resistance Training
- Keywords
- Plant-based diet, Red meat, Legumes, Protein intake, Anabolic diet, Resistance training, Muscle mass, Body composition, Older adults, Functional status, Sarcopenic obesity, Hypocaloric diet, Leucine, Physical function, Metabolic health, Aging population, Nutrition intervention, Randomized controlled trial
- Medical subject headings
- Obesity, Sarcopenia, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Legume-Based High-Protein Diet + Resistance TrainingBehavioural
Also called ProLegumes
Participants receive a hypocaloric, high-protein diet primarily based on legumes (e.g., lentils, beans, peas) designed to meet protein goals (~2g/kg body weight). Diet is combined with a structured home-based resistance training program performed 3 times per week for 12 weeks. The exercise includes progressive resistance exercises focusing on major muscle groups using body weight and resistance bands.
Meat-Based High-Protein Diet + Resistance TrainingBehavioural
Also called ProMeat
Participants follow a hypocaloric, high-protein diet emphasizing animal-based protein sources, mainly lean meats, to achieve ~2g/kg body weight protein intake. This dietary intervention is combined with a 12-week, home-based resistance training protocol, performed thrice weekly, targeting major muscle groups with progressive overload using body weight and resistance bands.
Mixed Legume and Meat High-Protein Diet + Resistance TrainingBehavioural
Also called ProMix
Participants adhere to a hypocaloric, high-protein diet combining both legumes and lean meats as protein sources to reach ~2g/kg body weight. The dietary plan is paired with a 12-week home-based resistance training program, performed 3 times per week, emphasizing progressive resistance exercises for all major muscle groups using body weight and resistance bands.
| Study group | Role | What they receive |
|---|---|---|
| ProLegumes Diet | Experimental | Participants in this arm will follow a hypocaloric, high-protein diet primarily based on legumes as the main protein source. The diet aims to improve sarcopenic obesity outcomes over a 3-month intervention period, combined with home-based resistance training. Receives: Behavioral: Legume-Based High-Protein Diet + Resistance Training |
| ProMeat Diet | Active comparator | Participants in this arm will follow a hypocaloric, high-protein diet primarily based on meat as the main protein source. This diet also aims to improve sarcopenic obesity outcomes over 3 months with the same exercise regimen. Receives: Behavioral: Meat-Based High-Protein Diet + Resistance Training |
| ProMix Diet | Active comparator | Participants in this arm will follow a hypocaloric, high-protein diet that includes a combination of both legumes and meat as protein sources. The intervention period and exercise program are identical to the other arms. Receives: Behavioral: Mixed Legume and Meat High-Protein Diet + Resistance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
MetaboAnabolic Score
The MetaboAnabolic Score is a composite outcome designed to assess the intervention's efficacy in addressing sarcopenic obesity from both metabolic and functional perspectives. The score includes 10 variables: five metabolic (body fat percentage, intramuscular adipose tissue [IMAT], visceral fat area, blood pressure, and triglyceride or LDL levels) and five functional (leg muscle/lean mass, leg and arm strength, Timed Up and Go [TUG], and 2-minute walk test). A clinically meaningful threshold is defined for each variable based on scientific literature or expected changes from the hypocaloric intervention. One point is awarded for each variable that meets or exceeds the threshold, resulting in a total score ranging from 0 to 10. A higher score reflects greater overall improvement.
Measured: Baseline, Week 6, Week 12
Secondary outcomes (10)
Functional Performance Tests (TUG, STS, Gait, Strength)
TUG, 2-minute walk, 30s sit-to-stand, one-leg stand (gait, endurance, stability).
Muscle strength of upper and lower limbs measured via handheld dynamometers. Gait variability and balance measured using Mobility Lab (OPAL) sensors
Measured: Baseline, Week 6, Week 12
C-Reactive Protein (CRP) Levels
High-sensitivity CRP will be measured via blood samples to assess systemic inflammation. CRP is a biomarker associated with metabolic and cardiovascular risk.
Measured: Baseline, Week 6, Week 12
Lipid Profile (Triglycerides, LDL, HDL, Total Cholesterol)
Fasting blood samples will be used to assess lipid parameters including triglycerides, low-density lipoprotein (LDL), high-density lipoprotein (HDL), and total cholesterol. These are key indicators of cardiovascular and metabolic health. Changes will be compared between intervention groups.
Measured: Baseline, Week 6, Week 12
Glycemic Control (Fasting Glucose, Insulin, HOMA-IR)
Fasting glucose and insulin levels will be used to evaluate glycemic control and insulin sensitivity. Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) will be calculated.
Measured: Baseline, Week 6, Week 12
Resting Metabolic Rate (RMR)
RMR will be measured via indirect calorimetry under standardized fasting and resting conditions. It reflects basal energy expenditure and can indicate metabolic adaptation or dysfunction. Changes will be analyzed in the context of body composition shifts.
Measured: Baseline and Week 12
Body Composition (Lean Mass, Fat Mass, Visceral Fat Area)
Dual-energy X-ray absorptiometry (DXA) and bioelectrical impedance analysis will be used to assess lean body mass, total fat mass, and visceral fat area. Changes in these components will provide insight into the impact of the dietary interventions on sarcopenic obesity.
Measured: Baseline, Week 6, Week 12
Muscle Quality Indices (Glycogen and Intramuscular Fat Levels)
Quantitative ultrasound will assess skeletal muscle glycogen storage and intramuscular fat infiltration (IMAT). This will be assessed by ultrasound of rectus femoris with MuscleSound® software, which analyzes cross-sectional area, thickness, and composition. These indices serve as biomarkers of muscle health and metabolic quality, with changes reflecting diet and exercise response.
Measured: Baseline, Week 6, Week 12
Ambulatory Blood Pressure (24-hour monitoring)
Blood pressure will be monitored over 24 hours using a validated automatic ambulatory device to capture daily fluctuations.
Measured: Baseline, Week 6, Week 12
Quality of Life (SF-12)
Health-related quality of life assessed using the validated SF-12 questionnaire, translated and culturally adapted to Hebrew.
Measured: Baseline, Week 6, Week 12
Hormonal Markers (Testosterone, IGF-1, Vitamin D)
Serum levels of testosterone (bioavailable and free), IGF-1, and 25-hydroxyvitamin D will be measured using standard clinical protocols.
Measured: Baseline, Week 6, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study startSep 2025 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sarcopenic ObesityStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of three parallel intervention arms: a legume-based high-protein hypocaloric diet (ProLegumes), a meat-based high-protein hypocaloric diet (ProMeat), or a mixed-source high-protein hypocaloric diet (ProMix). Each group follows their assigned intervention for the 12-week study period.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07030738
- Sponsor's protocol ID
- TLV-0540-23
- Status last verified
- May 2025
- First submitted
- 12 Jun 2025
- Last updated
- 22 Jun 2025
- 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 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plant (Legumes) vs Animal-based (Meat) Protein Sources as an Anabolic and Metabolic-protective Options for Sarcopenic Obesity in Older Adults- A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07030738
- Acronym / sponsor ID
- TLV-0540-23
- Conditions
- Sarcopenic Obesity, Obesity and Obesity-related Medical Conditions, Obesity (Body Mass Index >30 kg/m2), Sarcopenia, Muscle Loss, Aging
- Keywords
- Plant-based diet, Red meat, Legumes, Protein intake, Anabolic diet, Resistance training, Muscle mass, Body composition
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Sep 2025 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 22 Jun 2025 (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 is testing how different types of protein - from red meat, legumes (like lentils and beans), or a mix of both - affect muscle strength, body composition, and metabolic health in older adults with obesity who are also at risk for sarcopenia (loss of muscle mass and function). Participants will follow a personalized weight loss diet with one high-protein meal each day that includes either red meat, legumes, or both, along with a home-based strength training program. The study will last three months and will include health assessments such as blood tests, muscle and fat measurements, and physical function tests. The goal is to find out which type of protein source is most helpful for improving strength, reducing body fat, and supporting healthy aging.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned to one of three parallel intervention arms: a legume-based high-protein hypocaloric diet (ProLegumes), a meat-based high-protein hypocaloric diet (ProMeat), or a mixed-source high-protein hypocaloric diet (ProMix). Each group follows their assigned intervention for the 12-week study period.
| Arm | Type | Receives |
|---|---|---|
| ProLegumes Diet | Experimental | Behavioral: Legume-Based High-Protein Diet + Resistance TrainingParticipants in this arm will follow a hypocaloric, high-protein diet primarily based on legumes as the main protein source. The diet aims to improve sarcopenic obesity outcomes over a 3-month intervention period, combined with home-based resistance training. |
| ProMeat Diet | Active comparator | Behavioral: Meat-Based High-Protein Diet + Resistance TrainingParticipants in this arm will follow a hypocaloric, high-protein diet primarily based on meat as the main protein source. This diet also aims to improve sarcopenic obesity outcomes over 3 months with the same exercise regimen. |
| ProMix Diet | Active comparator | Behavioral: Mixed Legume and Meat High-Protein Diet + Resistance TrainingParticipants in this arm will follow a hypocaloric, high-protein diet that includes a combination of both legumes and meat as protein sources. The intervention period and exercise program are identical to the other arms. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 55 years or older.
- Diagnosed with obesity.
- At risk for sarcopenia, based on at least one of the following: Low score on the validated SARC-F-calf questionnaire (as suggested in prior studies). More than one comorbidity associated with sarcopenic obesity (e.g., diabetes, osteoporosis, cardiovascular disease, etc.). Polypharmacy: taking 8 or more prescribed medications. Evidence of strength or functional impairment, assessed using validated measurements at the baseline visit.
Key exclusion criteria (10 listed)
- Recent use of steroid agents within the past 6 months (replacement therapy is allowed).
- Uncorrected hypothyroidism: TSH > 6 mIU/L.
- Diagnosis of malignancy within the past 5 years, except for non-melanoma skin cancer.
- Chronic kidney disease (CKD) at stage >1 (due to protein restriction needs).
- Recent (≤6 months) or unstable cardiovascular condition, or NYHA Class III or higher congestive heart failure.
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-Based High-Protein Diet + Resistance TrainingAlso: ProLegumesParticipants receive a hypocaloric, high-protein diet primarily based on legumes (e.g., lentils, beans, peas) designed to meet protein goals (~2g/kg body weight). Diet is combined with a structured home-based resistance training program performed 3 times per week for 12 weeks. The exercise includes progressive resistance exercises focusing on major muscle groups using body weight and resistance bands. | Behavioural | ProLegumes Diet |
| Meat-Based High-Protein Diet + Resistance TrainingAlso: ProMeatParticipants follow a hypocaloric, high-protein diet emphasizing animal-based protein sources, mainly lean meats, to achieve ~2g/kg body weight protein intake. This dietary intervention is combined with a 12-week, home-based resistance training protocol, performed thrice weekly, targeting major muscle groups with progressive overload using body weight and resistance bands. | Behavioural | ProMeat Diet |
| Mixed Legume and Meat High-Protein Diet + Resistance TrainingAlso: ProMixParticipants adhere to a hypocaloric, high-protein diet combining both legumes and lean meats as protein sources to reach ~2g/kg body weight. The dietary plan is paired with a 12-week home-based resistance training program, performed 3 times per week, emphasizing progressive resistance exercises for all major muscle groups using body weight and resistance bands. | Behavioural | ProMix Diet |
Primary outcome
MetaboAnabolic Score
Time frame: Baseline, Week 6, Week 12
The MetaboAnabolic Score is a composite outcome designed to assess the intervention's efficacy in addressing sarcopenic obesity from both metabolic and functional perspectives. The score includes 10 variables: five metabolic (body fat percentage, intramuscular adipose tissue [IMAT], visceral fat area, blood pressure, and triglyceride or LDL levels) and five functional (leg muscle/lean mass, leg and arm strength, Timed Up and Go [TUG], and 2-minute walk test). A clinically meaningful threshold is defined for each variable based on scientific literature or expected changes from the hypocaloric intervention. One point is awarded for each variable that meets or exceeds the threshold, resulting in a total score ranging from 0 to 10. A higher score reflects greater overall improvement.
10 secondary outcomes
Functional Performance Tests (TUG, STS, Gait, Strength)
Time frame: Baseline, Week 6, Week 12
C-Reactive Protein (CRP) Levels
Time frame: Baseline, Week 6, Week 12
Lipid Profile (Triglycerides, LDL, HDL, Total Cholesterol)
Time frame: Baseline, Week 6, Week 12
Glycemic Control (Fasting Glucose, Insulin, HOMA-IR)
Time frame: Baseline, Week 6, Week 12
Resting Metabolic Rate (RMR)
Time frame: Baseline and Week 12
Body Composition (Lean Mass, Fat Mass, Visceral Fat Area)
Time frame: Baseline, Week 6, Week 12
Muscle Quality Indices (Glycogen and Intramuscular Fat Levels)
Time frame: Baseline, Week 6, Week 12
Ambulatory Blood Pressure (24-hour monitoring)
Time frame: Baseline, Week 6, Week 12
Quality of Life (SF-12)
Time frame: Baseline, Week 6, Week 12
Hormonal Markers (Testosterone, IGF-1, Vitamin D)
Time frame: Baseline, Week 6, Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
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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.
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-Based High-Protein Diet + Resistance Training, Meat-Based High-Protein Diet + Resistance Training and Mixed Legume and Meat High-Protein Diet + Resistance Training in people with Sarcopenic Obesity and Obesity and Obesity-related Medical Conditions, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 3 inclusion and 10 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: opening soon, as of the sponsor's last update on 22 Jun 2025. 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 Israel. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MetaboAnabolic Score (time frame: Baseline, Week 6, Week 12). 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 22 Jun 2025.