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

NCT ID: NCT06950684

Last Updated: 2025-04-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2028-07-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Protein Supplementation and Resistance Training

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.

Group Type: EXPERIMENTAL

Whey Protein Supplement

Intervention Type: 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

Resistance Training Program

Intervention Type: 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.

Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Whey Protein 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

Intervention Type: DIETARY_SUPPLEMENT

Resistance Training Program

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role: collaborator

Ariel University

OTHER

Sponsor Role: collaborator

Assuta Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Shiri Sherf Dagan

Dietitian and Epidemiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Shiri Sherf-Dagan, PhD

Role: CONTACT

shiris@ariel.ac.il

972525122203

Other Identifiers

1001829006

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

ASMC 0035-25 and TLV-0168-25

Identifier Type: -

Identifier Source: org_study_id