Bariatric surgery-related severe weight loss has been linked to loss of muscle mass, induced by poor protein absorption.
Researchers from Qatar University's College of Health Sciences plan to recruit around 160 post-bariatric surgery patients to be randomised and to follow up with for six months.
The subjects will include male and female obese (BMI above 35) Qatari patients aged 18 to 60 years. At the end of the trial, patients found to have consumed below 80% of the protein supplement will be excluded from the final analysis.
The supplement to be used in the treatment group will contain 20g of protein, while those in the placebo group will receive identical ampules containing zero-protein. Subjects in both groups will each take their respective doses orally, thrice a day.
The researchers will also measure the subjects' weight, muscle and fat mass, total protein albumin, vitamin B12, zinc and magnesium at baseline and at every follow-up or study visit.
Pros and cons
They said one of the study's strengths is its distinctive population, which gives it a specific and unique context.
They added that such a study "will provide healthcare providers in Qatar an opportunity to ensure good clinical practice and healthy and sustainable weight loss following bariatric surgery", as well as evidence-based clinical practice guidelines.
When it came to limitations, they said there would be a 'slight discrepancy' in the caloric content of the intervention (250 calories) and the placebo (100 calories). However, this may not influence the results to support the hypothesis that protein supplementation helps to increase muscle mass and lower fat mass.
In addition, the use of the placebo and the intervention are not objectively measured, but the researchers emphasised that they would "ensure compliance and reporting of consumption of products".
Lastly, they wrote that participants might drop out of the RCT after losing enough weight and reaching a level of fitness that makes them confident enough to consume any kind of food, which is commonly seen in the late stages of post-bariatric surgery.
They concluded: "We feel that this may be a challenge, particularly in reference to our specific population. However, such findings, albeit negative, should serve in improving the clinical practice delivered by healthcare providers."
Source: Archives of Public Health
"The effect of protein supplementation on body muscle mass and fat mass in post-bariatric surgery: a randomized controlled trial (RCT) study protocol"
Authors: Sahar D. Al-Shamari, et al.