Effectiveness of Protein SupplementatIon Combined With Resistance Exercise Training to Counteract Disproportional Fat-Free Mass Loss Following Metabolic-Bariatric Surgery: The ENRICHED Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Prevalence of Fat-free mass loss/Total weight loss >30%
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Control group - Standard care
Intervention group - Enriched care
干预措施: Resistance exercise training and protein supplementation (Behavioral)
结局指标
主要结局
Prevalence of Fat-free mass loss/Total weight loss >30%
时间窗: From enrollment to 3 months post-surgery
次要结局
- Weight (kg)(From enrollment to 12 months post-surgery)
- Body Mass Index (kg/m2)(From enrollment to 12 months post-surgery)
- Body composition (fat-mass/fat-free mass) (kg)(From enrollment to 12 months post-surgery)
- Waist circumference (cm)(From enrollment to 12 months post-surgery)
- Blood pressure (mmHg)(From enrollment to 12 months post-surgery)
- Quadriceps isometric strength (kg)(From enrollment to 12 months post-surgery)
- Quadriceps isometric power (Watt)(From enrollment to 12 months post-surgery)
- Handgrip strength (kg)(From enrollment to 12 months post-surgery)
- Short Physical Performance Battery (SPPB) score (scale 1-12 points)(From enrollment to 12 months post-surgery)
- VO2max (L/min)(From enrollment to 12 months post-surgery)
- Difference in Health-Related Quality of Life (HRQoL)(From enrollment to 12 months post-surgery)
- Incidence of gastrointestinal symptoms(From enrollment to 12 months post-surgery)
- Blood marker high-sensitivity C-Reactive Protein (hs-CRP) (mg/L)(From enrollment to 12 months post-surgery)
- Healthcare consumption (costs)(From enrollment to 12 months post-surgery)
- Blood marker HOMA-IR(From enrollment to 12 months post-surgery)
- Blood marker lipid profile(From enrollment to 12 months post-surgery)