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临床试验/NCT06680492
NCT06680492招募中不适用

The Role of Nutrition in Muscle Function of Bariatric Surgery Patients

Concordia University, Montreal1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2017年6月23日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
75
试验地点
1
主要终点
Change in weight

研究概览

简要总结

Current recommendations for protein intake after bariatric surgery are not based on strong scientific evidence. It remains unclear how much protein should be eaten to minimize muscle loss and preserve the metabolism and function of individuals post-bariatric surgery.

The objective of this study is to analyze the relationships between changes in body composition, nutrition and protein intake, and muscle function after bariatric surgery to further our understanding of the nutritional needs of patients after bariatric surgery.

We intend to recruit around 75 participants, men and women, aged between 18 and 65 years. Participants will be recruited from the Bariatric Surgery Clinic, McGill University Health Center.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male and female
  • Aged 18 to 65 years old
  • Undergoing first bariatric surgery (any type)
  • Diabetics and non-diabetics
  • Non-smokers and non-cannabis consumers

排除标准

  • Pregnant and breastfeeding women
  • Individuals undergoing second bariatric surgery
  • Regular smokers and cannabis consumers
  • Current use of Ozempic (or Ozempic-like medication) and anti-psychotic meds
  • Limited physical mobility (using walking aids such as canes, walkers, or wheelchairs) and issues with hand resistance
  • Kidney disease, non-controlled / unstable hypertension and hypothyroidism, and any metabolic disease other than diabetes

结局指标

主要结局

Change in weight

时间窗: Baseline (pre-operation), and at 3-months and 6-months post-operation.

Overall weight loss (kg)

Change in BMI

时间窗: Baseline (pre-operation), and at 3-months and 6-months post-operation.

Height and weight will be measured and combined to report BMI (kg/m\^2).

Change in fat mass

时间窗: Baseline (pre-operation), and at 3-months and 6-months post-operation.

Body composition is measured by dual-energy x-ray absorptiometry.

Change in overall body fat percentage

时间窗: Baseline (pre-operation), and at 3-months and 6-months post-operation.

Body composition is measured by dual-energy x-ray absorptiometry.

Resting Energy Expenditure

时间窗: Baseline (pre-operation), and at 3-months and 6-months post-operation.

Resting energy expenditure will be measured in a fasted state by indirect calorimetry. The volume of oxygen and carbon dioxide and water vapor pressure will be taken into consideration to calculate the resting energy expenditure.

Substrate Oxidation

时间窗: Baseline (pre-operation), and at 3-months and 6-months post-operation.

Substrate oxidation will be measured in a fasted state by indirect calorimetry. The volume of oxygen, carbon dioxide, and water vapor pressure will be taken into consideration to calculate the respiratory exchange ratio.

Nurition and Protein Intake

时间窗: Baseline (pre-operation), and at 3-months and 6-months post-operation.

A 3-day food journal and a 24-hour food recall will measure the nutritional profile (protein intake). A 24-hour urine sample will be used to measure urinary nitrogen concentration.

Hormone and Inflammatory Marker Assays

时间窗: Baseline (pre-operation), and at 3-months and 6-months post-operation.

The inflammatory cytokines, chemokines, and adipokines in blood will be measured using Enzyme-Linked Immunosorbent Assay (ELISA).

次要结局

未报告次要终点

研究者

发起方
Concordia University, Montreal
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sylvia Santosa

Professor

Concordia University, Montreal

研究点 (1)

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