Effect of Protein Supplementation and a Structured Physical Exercise Program on Changes in Body Composition, Metabolic Flexibility (Energy Consumption of Substrates), and Functionality in Women During Weight Loss Induced by BS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Strength
研究概览
简要总结
Obesity is considered a chronic disease that increases the risk of developing diseases that reduce life expectancy. The treatment of obesity is complex. However, treatments based exclusively on dietary changes have not shown long-term efficacy especially in people with severe obesity. In contrast, in this group of people bariatric surgery (BS) has shown good long-term results in weight loss and maintenance. These changes are accompanied by significant improvements in health, improved quality of life, and reduced mortality. However, the changes in the digestive system created by BS and the high level of dietary restriction, affect the nutritional status and require a proper supplementation of vitamins and minerals during the follow-up. Intense weight loss during the first few months, coupled with an insufficient amount of protein in the diet, can lead to a loss of muscle mass. Excessive muscle loss during the short-term period can lead to functional repercussions (decreased strength and physical function) and reduced calories that the body burns daily. Naturally, this is especially important in people suffering from sarcopenia before BS, and it occurs more frequently in postmenopausal women. Despite this is known, specific protein intake recommendations after BS have not yet been defined based on scientific evidence. In this context, the first part of our proposal will assess the effect of two levels of protein supplementation: standard (S-PS) versus high (H-PS) on changes in a) body composition, b) energy expenditure, c) metabolic flexibility d) the physical condition during weight loss that follows BS. In addition, in patients with H-PS, the added effect of a physical exercise program, carried out with a personal trainer (professional of sports medicine trainer) virtually, will be evaluated. Protein supplementation and the virtual exercise program will be done during the 4 months following BS, and the results will be studied at 4, 8, and 12 months. Once the results have been defined, it is essential to transfer the recommendations to the real world. In a second part, and to achieve knowledge transfer to clinical practice, the investigators will explore the key elements that influence patient experience (XPA).
详细描述
Obesity is considered a chronic disease that increases the risk of developing diseases that reduce life expectancy. The treatment of obesity is complex. However, treatments based exclusively on dietary changes have not shown long-term efficacy especially in people with severe obesity. In contrast, in this group of people bariatric surgery (BS) has shown good long-term results in weight loss and maintenance. These changes are accompanied by significant improvements in health, improved quality of life, and reduced mortality. However, the changes in the digestive system created by BS and the high level of dietary restriction, affect the nutritional status and require a proper supplementation of vitamins and minerals during the follow-up. Intense weight loss during the first few months, coupled with an insufficient amount of protein in the diet, can lead to a loss of muscle mass. Excessive muscle loss during the short-term period can lead to functional repercussions (decreased strength and physical function) and reduced calories that the body burns daily. Naturally, this is especially important in people suffering from sarcopenia before BS, and it occurs more frequently in postmenopausal women. Despite this is known, specific protein intake recommendations after BS have not yet been defined based on scientific evidence. In this context, the first part of our proposal will assess the effect of two levels of protein supplementation: standard (SP-S) versus high (SP-A) on changes in a) body composition, b) energy expenditure, c) metabolic flexibility d) the physical condition during weight loss that follows BS. In addition, in patients with SP-Alta, the added effect of a physical exercise program, carried out with a personal trainer (professional of sports medicine trainer) virtually, will be evaluated. Protein supplementation and the virtual exercise program will be done during the 4 months following CO, and the results will be studied at 4, 8, and 12 months. Once the results have been defined, it is essential to transfer the recommendations to the real world. In a second part, and to achieve knowledge transfer to clinical practice, the investigators will explore the key elements that influence patient experience (XPA). The investigators will define indicators to assess it, especially those that are related to adherence to nutritional recommendations and to changes in lifestyle. The investigators are currently in the recruitment phase of the study. I have studied the necessary elements, ambitions and included the components that will help to define the dietary and lifestyle recommendations for our population. Aim to facilitate and define the performance of the professionals providing realistic, based on the XPA and in this way to improve the impact of the CO on health and quality of life. This is an ambitious and necessary study and includes all the component that will help define dietary and lifestyle recommendations for our population. It aims to facilitate and define the action of professionals provides realistic tools, based on XPA and thus improve the impact of BS on health and quality of life.
Description of the population to study sedentary women, candidates for BS at our institution.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women ≥45 years of age who meet CB criteria: Body mass index (BMI) ≥40.0 kg / m2 or between 35.0 and 39.9 kg / m2 with comorbidities (metabolic diseases, cardiorespiratory diseases), sedentary lack of regular physical activity: <30 minutes / day and <3 days / week).
排除标准
- •presence of severe joint disease, severe liver disease, history of cardiovascular event or known heart disease, renal failure (defined as a FG <30 ml / min), type 1 or type 2 diabetes with HbA1c> 10%, being treated with drugs that may affect body composition (such as corticosteroids), exercise muscle strength-endurance regularly (more than 2 times / week), have previously undergone obesity surgery.
研究组 & 干预措施
standard protein supplementation (SPS)
0.8g protein/ IBW/ day
干预措施: Protein Supplementation (Dietary Supplement)
High protein supplementation (HPS)
1.2g protein/ IBW/ day
干预措施: Protein Supplementation (Dietary Supplement)
HPS + PA
1.2g protein/ IBW/ day + PA 3 times a week/ 12 weeks
干预措施: Protein Supplementation (Dietary Supplement)
结局指标
主要结局
Strength
时间窗: 12 months after BS
changes from baseline on prediction of ne repetition máximum (1-RM) and hang grip.
Adherence to PS (BCAA biomarker)
时间窗: 12 months after BS
serum change in BCAA (mcg)
Metabolic flexibility - oxidation of substrates: VO2 peak
时间窗: 12 months after BS
change in VO2 peak measured by Ergocard during half-effort test
Adherence to PS (urinary nitrogen 24hs.)
时间窗: 12 months after BS
Nitrogen (mg) values quantified in 24hs urine
Functionality
时间窗: 12 months after BS
changes from baseline on sit and stand
Fat oxidation (FatMax) during during half-effort test
时间窗: 12 months after BS
Time to spend to reach the cross over pony for RQ=1 determined by Ergocard during half-effort test (min)
Understand patients' priorities and the "painful points" of the care process. Explore the magnitude of these "painful points." This should make it possible to prioritize the areas to be evaluated. Test assessment tools
时间窗: 12 months after BS
identify by focus group patient reported outcomes by cualitative study
effect of PS and PA on Changes in fat mass and Fat free mass (kg)
时间窗: 12 months after BS
change from baseline in DEXA values
effect of PS and PA on resting energy expenditure (REE) (Kcal/ day)
时间窗: 12 months after BS
change from baseline in estimated REE from indirect calorimety
Respiratory quotient
时间窗: 12 months after BS
change in RQ determined by Ergocard during half-effort test
Functionality
时间窗: 8 months after BS
changes from baseline on sit and stand
effect of PS and PA on Changes in fat mass and Fat free mass (kg)
时间窗: 4 months after BS
change from baseline in DEXA values
effect of PS and PA on Changes in fat mass and Fat free mass (kg)
时间窗: 8 months after BS
change from baseline in DEXA values
effect of PS and PA on resting energy expenditure (REE) (Kcal/ day)
时间窗: 4 months after BS
change from baseline in estimated REE from indirect calorimety
effect of PS and PA on resting energy expenditure (REE) (Kcal/ day)
时间窗: 8 months after BS
change from baseline in estimated REE from indirect calorimety
Strength
时间窗: 4 months after BS
changes from baseline on prediction of ne repetition máximum (1-RM) and hang grip.
Strength
时间窗: 8 months after BS
changes from baseline on prediction of ne repetition máximum (1-RM) and hang grip.
Functionality
时间窗: 4 months after BS
changes from baseline on sit and stand
Metabolic flexibility - oxidation of substrates: VO2 peak
时间窗: 4 months after BS
change in VO2 peak measured by Ergocard during half-effort test
Metabolic flexibility - oxidation of substrates: VO2 peak
时间窗: 8 months after BS
change in VO2 peak measured by Ergocard
Respiratory quotient
时间窗: 4 months after BS
change in RQ determined by Ergocard during half-effort test
Respiratory quotient
时间窗: 8 months after BS
change in RQ determined by Ergocard during half-effort test
Fat oxidation (FatMax) during during half-effort test
时间窗: 4 months after BS
Time to spend to reach the cross over pony for RQ=1 determined by Ergocard during half-effort test (min)
Fat oxidation (FatMax) during during half-effort test
时间窗: 8 months after BS
Time to spend to reach the cross over pony for RQ=1 determined by Ergocard during half-effort test (min)
Adherence to PS (BCAA biomarker)
时间窗: 4 months after BS
serum change in BCAA (mcg)
Adherence to PS (BCAA biomarker)
时间窗: 8 months after BS
serum change in BCAA (mcg)
Adherence to PS (urinary nitrogen 24hs.)
时间窗: 4 months after BS
Nitrogen (mg) values quantified in 24hs urine
Adherence to PS (urinary nitrogen 24hs.)
时间窗: 8 months after BS
Nitrogen (mg) values quantified in 24hs urine
次要结局
- Changes in BMI(12 months after BS)
- Insulin sensitivity (HOMA-IR)(12 months after BS)
- Changes in BMI(4 months after BS)
- Changes in BMI(8 months after BS)
- Insulin sensitivity (HOMA-IR)(4 months after BS)
- Insulin sensitivity (HOMA-IR)(8 months after BS)
研究者
Violeta Moizé
PhD
Hospital Clinic of Barcelona