Plant vs Animal-based Protein Sources as an Anabolic and Metabolic-protective Options for SO in Older Adults

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55+
SponsorTel-Aviv Sourasky Medical Center

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Legume-Based High-Protein Diet + Resistance Training

    Behavioral

    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 Training

    Behavioral

    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 Training

    Behavioral

    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.

Treatment groups

180 Participants
are divided into 3 treatment groups
Group A: ProLegumes DietExperimental treatment 1 intervention
Group B: ProMeat DietActive comparator 1 intervention
Group C: ProMix DietActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, Week 6, Week 12

Secondary outcomes

1

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

Time frame
Baseline, Week 6, Week 12
2

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.

Time frame
Baseline, Week 6, Week 12
3

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.

Time frame
Baseline, Week 6, Week 12
4

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.

Time frame
Baseline, Week 6, Week 12

Other outcomes

1

Banked Blood and Serum for Future Biomarker and Epigenetic Analysis

Frozen plasma and blood samples will be collected and stored at -20 °C and - 80 °C respectively for future testing of myokines, adipokines, and epigenetic markers.

Time frame
Baseline, Week 6, Week 12

Sponsors and contacts

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