Comparison of the effectiveness of the egg white protein and zinc-enriched synbiotic supplement and placebo on the muscle strength, muscle mass and quality of life in older adults with sarcopenia

The aim of this study is to determine the Effects of egg white protein (Albumen) and zinc-enriched synbiotic supplement on the muscle strength, muscle mass and quality of life in older adults with sarcopenia.

A double blind, randomized with permuted block randomization, controlled clinical trial with a parallel group design (phase 3) on 72 patients

Sampling are performed among the elderly aged 65 and older who refer to 6 medical centers in Shiraz and then sarcopenia is evaluated in the bone densitometry department of Namazi Hospital in Shiraz. Participants, researchers, and outcome assessors were blinded through apparent similarity of the intervention and placebo.

Inclusion criteria: Men and women aged 65 years and older; Sarcopenia diagnosis according to European Working Group on Sarcopenia in Older People (EWGSOP) guidelines; using calcium and vitamin D supplements. Non-Inclusion criteria: Subjects with history of chronic disease (e.g. Congestive Heart Failure (CHF), Chronic Obstructive Pulmonary Disorder (COPD), Chronic Renal Failure (CRF), cirrhosis liver failure, active cancer, uncontrolled diabetes and stroke.

Intervention group: Participants in intervention group consume egg white protein and zinc-enriched synbiotic supplement, daily for 8 weeks. Control group: Participants in control group consume daily placebo powder for 8 weeks

Appendicular Skeletal Muscle Mass; Skeletal Muscle Mass Index (SMI); Hand Grip Strength (HGS); Weight; BMI; Waist circumference; Calf circumference; Arm circumference; Fat mass; Percent of Fat; Gynoid fat mass; Android fat mass; Quality of life; Physical performance (SPPB); Fasting Blood sugar (FBS) level; Lipid profile (LDL, HDL, Triglyceride, total cholesterol)

Randomization of participants into placebo and target groups will be done by permuted block randomization. In this way, the size of block is considered 6 and all possible scenarios will be written for the two intervention and control groups, and this will be repeated until the number reaches 72. The method of concealing the allocation is to use a non-transparent sealed envelope in which each of the random entries created is recorded on a card and the cards are arranged inside the envelopes. At the beginning of the registration of participants, based on the order of entry of eligible participants to study, one of the envelopes of the letter is opened in order and the assigned group of the participant is revealed.

All participants in this study are unaware about their grouping because the appearance of the target and placebo are quite similar. Participants are not referred based on their group to clinical follow-up and outcome evaluator and he/she is also unaware of the separation of individuals. The principle investigators are not directly connected with the participants, so they are not aware of their grouping. An importer of data will also be outside the study system, which is generally unaware of the nature of the study.