Protein Supplementation and Resistance Training to Prevent Fat-Free Mass Loss Following Metabolic-Bariatric Surgery

Официальное название

Effectiveness of Protein SupplementatIon Combined With Resistance Exercise Training to Counteract Disproportional Fat-Free Mass Loss Following Metabolic-Bariatric Surgery: The ENRICHED Study

Обзор

The goal of this clinical trial is to investigate the effects of daily protein supplementation and participation in a weekly supervised resistance training program on the prevention of excessive muscle mass loss following bariatric surgery. Patients treated at one of the participating centers will be invited to participate and will be randomly assigned to one of two groups. Participants in group 1 will receive standard postoperative care as currently provided. Participants in group 2 will also receive standard care, but in addition, they will be asked to consume extra protein daily and take part in a supervised resistance training session once a week. Previous research has shown that approximately one in five patients undergoing bariatric surgery experiences excessive muscle loss after the surgery. It is known that resistance training and protein intake can help maintain and even improve muscle mass. However, limited research has been conducted on the combined effects of protein supplementation and resistance training in patients after bariatric surgery. Therefore, the aim of this trial is to determine whether participants receiving the additional intervention experience less muscle mass loss compared to those receiving standard care alone.

Вмешательства

• Поведенческое Resistance exercise training and protein supplementation
  The intervention consists of two components: 1. Resistance Exercise Training Participants will engage in a 24-week resistance training program. This program includes one supervised session per week supervised by a qualified kinesiologist, complemented by two to three additional unsupervised sessions per week performed at home. 2. Protein Supplementation Participants will receive daily protein supplements for a total duration of 12 weeks. The dosage will be progressively increased: * 20 grams

Первичные конечные точки

• Prevalence of Fat-free mass loss/Total weight loss >30% [Срок оценки: From enrollment to 3 months post-surgery]

Вторичные конечные точки (12)

• Weight (kg) [Срок оценки: From enrollment to 12 months post-surgery]
• Body Mass Index (kg/m2) [Срок оценки: From enrollment to 12 months post-surgery]
• Body composition (fat-mass/fat-free mass) (kg) [Срок оценки: From enrollment to 12 months post-surgery]
• Waist circumference (cm) [Срок оценки: From enrollment to 12 months post-surgery]
• Blood pressure (mmHg) [Срок оценки: From enrollment to 12 months post-surgery]
• Quadriceps isometric strength (kg) [Срок оценки: From enrollment to 12 months post-surgery]
• Quadriceps isometric power (Watt) [Срок оценки: From enrollment to 12 months post-surgery]
• Handgrip strength (kg) [Срок оценки: From enrollment to 12 months post-surgery]
• Short Physical Performance Battery (SPPB) score (scale 1-12 points) [Срок оценки: From enrollment to 12 months post-surgery]
• VO2max (L/min) [Срок оценки: From enrollment to 12 months post-surgery]
• Incidence of gastrointestinal symptoms [Срок оценки: From enrollment to 12 months post-surgery]
• Difference in Health-Related Quality of Life (HRQoL) [Срок оценки: From enrollment to 12 months post-surgery]

Критерии участия

Критерии включения

• A scheduled metabolic-bariatric surgery (i.e. RYGB or Sleeve Gastrectomy)
• Participation in the NOK care program
• Able to understand and perform the study procedures

Критерии исключения

• Allergic or sensitive for milk proteins, or lactose intolerant
• Diagnosed renal insufficiency
• Diagnosed intestinal diseases influencing the uptake of protein (i.e. active inflammatory bowel disease

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

Профилактика

Центры проведения

Нидерланды · 2 центра

• Nederlandse Obesitas Kliniek — Amsterdam
• Nederlandse Obesitas Kliniek — Nieuwegein

Публикации

• de Roos BM, Yeh LY, van den Hooff PS, Nuijten MAH, Twisk JWR, Liem RSL, van Acker GJD, Severens JL, Kambic T, Serlie MJM, Monpellier VM, Eijsvogels TMH, Hopman MTE, Karregat JHM. Effectiveness of protein supplementation combined with resistance training to counteract disproportional fat-free mass loss following metabolic bariatric surgery: rationale and design of the ENRICHED randomised controlled PMID 41469063

Идентификаторы

NCT: NCT07156552 · NL87367.091.24

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗