Lifestyle Intervention to Improve Muscle Function in Older Adults

Обзор

The goal of this randomized controlled two-arm trial is to determine the effect of a diet and exercise intervention for 12 weeks on body composition, muscle function, and energy balance in 80 adults aged 50 years and over with obesity and insulin resistance. The main questions the trial aims to answer are: Will 12 weeks of a structured nutrition plan + exercise reduce fat mass, improve muscle function, and increase energy deficit compared to the usual diet + exercise. The hypothesis is that 12 weeks of a structured nutrition plan + exercise will reduce fat mass, improve muscle function, and produce greater energy deficit than the usual diet + exercise. Participants will be provided with all meals for 12 weeks and will exercise at the Center under supervision three times each week. Pre and post-intervention, body composition, physical function, and energy deficit will be measured.

Подробное описание

In the United States nearly one third of adults over 60 years of age have sarcopenic obesity which encompasses the combined effect of muscle impairment and obesity. A strategy that addresses the combined effect of muscle impairment and obesity while modulating muscle mass and composition is an unanswered challenge. This 12-week study will evaluate the effects of a structured nutrition plan combined with an exercise program on body fat and muscle mass, lower-extremity function (Short Physical Performance Battery), muscle strength (handgrip and knee strength), and daily caloric intake. The study will enroll adults aged 50 years and older with obesity (body mass index ≥ 30 kg/m²) and insulin resistance as indicated by a homeostasis model assessment of insulin resistance (HOMA-IR) score ≥ 3. Subjects will be randomly allocated to receive the structured nutrition plan and exercise intervention or to their usual diet and exercise in equal numbers (40 per group). The study will enrich our understanding of the physiological adaptations necessary for effective lifestyle interventions to improve muscle function.

Вмешательства

• Поведенческое Structured nutrition plan
  Participants will receive a structured nutrition plan.
• Поведенческое Typical or usual diet
  Participants will receive a diet representing the usual diet in this population.
• Поведенческое Supervised Exercise
  Participants will complete aerobic and resistance training under supervision three times per week.

Первичные конечные точки

• Fat mass [Срок оценки: Change from baseline to 12 weeks]

Вторичные конечные точки (10)

• Skeletal muscle mass [Срок оценки: Change in from baseline to 12 weeks]
• Short physical performance battery [Срок оценки: Change from baseline to 12 weeks]
• Hand-grip strength [Срок оценки: Change from baseline to 12 weeks]
• Knee strength [Срок оценки: Change from baseline to12 weeks]
• Energy stores [Срок оценки: 12 weeks]
• Hormonal regulation of energy balance [Срок оценки: Change from baseline to 12 weeks]
• Hormonal regulation of energy balance [Срок оценки: Change from baseline to 12 weeks]
• Hormonal regulation of energy balance [Срок оценки: Change from baseline to 12 weeks]
• Hormonal regulation of energy balance [Срок оценки: Change from baseline to 12 weeks]
• Cardiorespiratory fitness [Срок оценки: Change in VO2max from baseline to 12 weeks]

Критерии участия

Критерии включения

• Age > 50 years.
• Body mass index (BMI) ≥ 30 kg/m2.
• Homeostatic model assessment of insulin resistance ≥ 3.
• Mini-Mental State Examination (MMSE) > 25.
• Geriatric Depression Scale-15 (GDS-15) < 9.
• Sedentary (less than 90 minutes/week of moderate to vigorous activity).
• Ability to provide written informed consent.

Критерии исключения

• Diagnosis of cancer (received within five years) or diabetes (type 1 and 2), or significant musculoskeletal, or cardiovascular, or hepatic, or renal, disease or dysfunction.
• Clinically significant gastrointestinal malabsorption syndromes such as chronic diarrhea, celiac disease, or clinically significant abnormal laboratory markers.
• Fluctuation in body weight > 3 kg in the preceding two months
• Condition that impedes testing of the study hypothesis or makes it unsafe to exercise or consume the study foods.

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

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Pennington Biomedical Research Center — Baton Rouge

Идентификаторы

NCT: NCT07597980 · PBRC-2025-060 · 1R01AG092725-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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