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

NCT06950684 | Not Yet Recruiting

• 2 other identifiers: ASMC 0035-25 and TLV-0168-251001829006
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Obesity; Overweight (BMI > 25); Weight Loss

Keywords

Protein supplementation; Resistance training; Body composition; Metabolic rate; Nitrogen balance; Incretin-based medications; Wegovy; Mounjaro; Older adults; Obesity treatment

Outcome Measures

Primary Outcomes (5)

• Change in Fat Mass (kg)

  Change in fat mass (in kilograms) as measured by InBody 770 bioelectrical impedance analysis

  Baseline, 3 months, 6 months.

• Change in Fat Mass Percentage (%)

  Change in fat mass percentage (%) as measured by InBody 770 bioelectrical impedance analysis

  Baseline, 3 months, 6 months.

• Change in Lean Body Mass (kg)

  Change in lean body mass (in kilograms) as measured by InBody 770 bioelectrical impedance analysis.

  Baseline, 3 months, 6 months.

• Change in Skeletal Muscle Mass (kg)

  Change in skeletal muscle mass (in kilograms) as measured by InBody 770 bioelectrical impedance analysis.

  Baseline, 3 months, 6 months.

• Change in Body Mass Index (BMI)

  hange in Body Mass Index (BMI), calculated as weight in kilograms divided by height in meters squared (kg/m²), based on body weight measured by InBody 770.

  Baseline, 3 months, 6 months.

Secondary Outcomes (9)

• Change in Resting Metabolic Rate

  Baseline, 3 months, 6 months.

• Change in Nitrogen Balance

  Baseline, 3 months, 6 months.

• Change in Short Physical Performance Battery (SPPB) score

  Baseline, 3 months, 6 months.

• Change in Sit-to-Stand Test Performance

  Baseline, 3 months, 6 months.

• Change in Handgrip Strength

  Baseline, 3 months, 6 months.

Study Arms (2)

Protein Supplementation and Resistance Training

EXPERIMENTAL

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.

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

Control Group

NO INTERVENTION

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

Interventions

Whey Protein Supplement DIETARY_SUPPLEMENT

Participants will take a daily supplement of whey protein powder (Easy Whey) providing 25 grams of protein each day for the duration of 6 months

Protein Supplementation and Resistance Training

Resistance Training Program BEHAVIORAL

Participants will engage in resistance training consisting of one guided online session each week and two additional independent resistance training sessions weekly, totaling three sessions per week, for a duration of 6 months.

Protein Supplementation and Resistance Training

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assuta Medical Center: lead
• Tel-Aviv Sourasky Medical Center: collaborator
• Ariel University: collaborator

MeSH Terms

Conditions

Obesity; Overweight; Weight Loss

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Central Study Contacts

Shiri Sherf-Dagan, PhD

CONTACT

972525122203; shiris@ariel.ac.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dietitian and Epidemiologist

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: April 30, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: April 30, 2025

Record last verified: 2025-04