NCT07030738Not yet recruiting
Plant vs Animal-based Protein Sources as an Anabolic and Metabolic-protective Options for SO in Older Adults
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
Source: ClinicalTrials.gov · Last updated 22 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- First submitted
- 12 Jun 2025
- Start date
- 1 Sept 2025
- Primary completion date
- 31 Mar 2026
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Diseases
- Obesity
- NCT number
- NCT07030738
What you commit to
- Study type: Interventional
- Planned participants: 180
- From 1 Sept 2025 to the primary completion date, 31 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recent use of steroid agents within the past 6 months (replacement therapy is allowed).
- 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.
Other illness
- 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.
- Vegetarians/vegans, or individuals with aversion or allergy to all legumes or all red meat products.
- Other medical, psychiatric conditions, or lab abnormalities that may pose a risk to participation.
Other
- Uncorrected hypothyroidism: TSH \> 6 mIU/L.
- Currently performing resistance training.
- Habitual consumption of more than 3 servings/week of either legumes or red meat.
Who the study is looking for
- 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.
Age in the registry: 55 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tel-Aviv Sourasky Medical Center Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.