Protein Supplementation Impact On Body Muscle Mass And Fat Mass In Qataris Post Bariatric Surgery, Randomized Controlled Trials (Rcts)
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Measurement of changes in Body Weight
研究概览
简要总结
One of the most common post-operative deficiencies or complications of bariatric surgery is protein malnutrition. It may lead to many predicaments such as malnutrition, vitamin, micro- and macronutrient deficiencies that can lead to deleterious consequences. A protein-rich diet make a person feel satiety and thereby the consumption will be low in overall energy intake. The objectives of our study are. The aim of this study is to assess the effect of protein supplementation on changes in health parameters such as fat mass, muscle mass, weigh change, protein (total and albumin), Vit B12, Zinc and Magnesium, in Qatari patients post bariatric surgery. Our participants are Qatari aged 18-45 years males and females recruited from the bariatric surgery centers of 2 major HMC hospitals (HGH hospital) and will be randomized to receive either the protein supplement (treatment group) or a dietary advice (control group). All participants will be equally followed and monitored for 3 months and data on the above parameters will be collected, together with other population characteristics, at Baseline, 1 month and 3 month. Data will then be analyzed using the most up-to-date SPSS statistical package to assess the effect of protein supplementation on the parameters of interest. Statistical measures will be carefully chosen to properly assess the difference in the treatment (protein supplementation) effect compared with the control (Dietary advice). Investigators hypothesize that Patients receiving protein supplement (intervention group) Compared with patient not on protein supplement (placebo group) will maintain weight loss and other essential health parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Investigators and researchers in this study will be blinded to the intervention, i.e. they will not be aware of who is on protein supplement and who is on placebo. Patients will also be blinded to the intervention, i.e. they will not know whether they are taking protein or zero protein supplement. For the blinding there will be a dietician who will assign the treatment and the control to patients as per the above randomization results. This dietician will also be responsible for filling the intervention & control ready-to-feed shakes into identical bottles labeled either A or B, the dietician will not have any other responsibility such as data entry or follow up of participants as this will be done by the PI and research team, he will only be responsible for the blinding process.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Study participants must have the following criteria in order to participate in the trial:
- •Qatari males or females.
- •Aged between 18 and 60 year
- •Based at the bariatric surgery list of HMC with their follow up scheduled be at HMC.
排除标准
- •Patients will be excluded from participating in the trial if they have the following criteria:
- •Any Renal or liver disease because that will affect protein or albumin level in body.
- •Past history of bariatric surgery
- •Patients will be further excluded after starting the trial if they fall into the following categories:
- •Subjects who did not take at least 80% of their intervention product amount per day, or
- •Subjects who did not comply with the treatment (or placebo) for more than 3 days per week.
- •Also, patients who refuse to participate & patients with baseline tests showing they are in need for protein supplements will be excluded from the study and given the needed protein supplements per the standard care.
结局指标
主要结局
Measurement of changes in Body Weight
时间窗: 3 months
Measurement of changes in Body Weight
Measurement of changes in Fat mass.
时间窗: 3 months
Measurement of changes in Muscle mass.
Measurement of changes in Muscle mass.
时间窗: 3 months
Measurement of changes in Muscle mass.
次要结局
- To assess the Zinc level measurement(3 months)
- To assess the measurement on Vitamin B12(3 months)
- To assess the measurement on Protein(3 months)
- To assess the measurement on Magnesium(3 months)