Impact of Protein Supplementation and Resistance Training on Body Composition, Functional Parameters, Metabolic Adaptation, and Nitrogen Balance in Adults Aged 45 Years and Older With Overweight or Obesity Receiving Incretin-based Medications (PRIME)

Assuta Medical Center

Status: Not yet enrolling

Conditions: Weight Loss; Obesity; Overweight (BMI > 25)

Treatments: Dietary Supplement: Whey Protein Supplement; Behavioral: Resistance Training Program

Study type: Interventional

Funder types: Other

Identifiers

NCT06950684

ASMC 0035-25 and TLV-0168-25

1001829006 (Other Grant/Funding Number)

Details and patient eligibility

About

This study aim to evaluate the effects of protein supplements and resistance training on body composition, functional parameters, metabolic adaptation, and nitrogen balance in adults (aged ≥45 years) with overweight/obesity receiving weekly Incretin-Based obesity management medication treatment for 6 months.

A parallel design, open-label, multicenter randomized controlled trial will be conducted among 240 patients (aged ≥45 years) initiating Incretin-Based obesity management medication. Participants will be recruited through obesity clinics at the Tel-Aviv Sourasky Medical Center and the Tel-Aviv Assuta Medical Center, obesity clinics of HMOs, and social media groups. They will be randomly assigned to one of two groups in a 1:1 ratio: protein supplements ('Easy Whey' 25 gr protein/day) plus weekly resistance training and no intervention. Data will be collected at baseline, 3, and 6 months, including demographics, medical status, body composition, functional parameters, resting metabolic rate, nitrogen balance, and physical activity performance.

All participants will be advised to follow an exercise regime, a reduced-calorie diet based on the principle of the Mediterranean eating pattern and be encouraged to follow a regular meeting schedule with a registered dietitian.

Enrollment: 180 estimated patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults aged ≥45 years.
• Overweight or obese (BMI ≥30, or BMI ≥27 with at least one obesity-related comorbidity).
• Eligible to receive incretin-based weight loss medications (e.g. Wegovy or Mounjaro).
• Able to read and speak Hebrew fluently.

Exclusion criteria

• Medical contraindications for incretin-based weight-loss medications.
• Current treatment with insulin or sulfonylurea medications.
• Inflammatory bowel disease.
• Active or unstable psychiatric disorders or cognitive impairment.
• Active bulimia nervosa.
• Previous bariatric surgery or bariatric endoscopic procedures.
• Use of other weight management medications within the past month.
• Weight loss of ≥5% within the past three months.
• Implanted cardiac pacemaker or other electronic implants.
• Regular resistance training within the past three months.
• Regular use of protein supplements.
• Allergy or intolerance to dairy proteins or vegan lifestyle.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Protein Supplementation and Resistance Training

Experimental group

Description:

Participants in this arm will consume a daily dietary supplement of 25 grams of whey protein powder (Easy Whey) and participate in a structured resistance training program consisting of one guided online session per week, plus two additional independent sessions weekly, for a total duration of 6 months.

Treatment:

Behavioral: Resistance Training Program

Dietary Supplement: Whey Protein Supplement

Control Group

No Intervention group

Description:

Participants in this arm will not receive protein supplementation or structured resistance training. They will be provided with general dietary recommendations at the beginning of the study and will continue their usual care for 6 months