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

Официальное название

The Effect of Protein Supplementation and Resistance Training on Body Composition, Functional Parameters, Metabolic Adaptation, and Nitrogen Balance in Adults (Aged ≥45 Years) With Overweight/Obesity Receiving Incretin-Based Weight Loss Medication for 6 Months: A Multicenter RCT

Обзор

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.

Вмешательства

• Пищевая добавка 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
• Поведенческое 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.

Первичные конечные точки

• Change in Fat Mass (kg) [Срок оценки: Baseline, 3 months, 6 months.]
• Change in Fat Mass Percentage (%) [Срок оценки: Baseline, 3 months, 6 months.]
• Change in Lean Body Mass (kg) [Срок оценки: Baseline, 3 months, 6 months.]
• Change in Skeletal Muscle Mass (kg) [Срок оценки: Baseline, 3 months, 6 months.]
• Change in Body Mass Index (BMI) [Срок оценки: Baseline, 3 months, 6 months.]

Вторичные конечные точки (9)

• Change in Resting Metabolic Rate [Срок оценки: Baseline, 3 months, 6 months.]
• Change in Nitrogen Balance [Срок оценки: Baseline, 3 months, 6 months.]
• Change in Short Physical Performance Battery (SPPB) score [Срок оценки: Baseline, 3 months, 6 months.]
• Change in Sit-to-Stand Test Performance [Срок оценки: Baseline, 3 months, 6 months.]
• Change in Handgrip Strength [Срок оценки: Baseline, 3 months, 6 months.]
• Change in Nutrient Intake Based on 3-Day Food Diaries [Срок оценки: Baseline, 3 months, 6 months.]
• Change in Mediterranean Diet Adherence [Срок оценки: Baseline, 3 months, 6 months.]
• Change in Eating Behavior - Control of Eating Questionnaire (CoEQ) [Срок оценки: Baseline, 3 months, 6 months.]
• Change in Food Reward Sensitivity - Power of Food Scale (PFS) [Срок оценки: Baseline, 3 months, 6 months.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06950684 · ASMC 0035-25 and TLV-0168-25 · 1001829006

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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