Protein-enriched meal replacements do not adversely affect liver, kidney or bone density: an outpatient randomized controlled trial

Background: There is concern that recommending protein-enriched meal replacements as part of a weight management program could lead to changes in biomarkers of liver or renal function and reductions in bone density. This study was designed as a placebo-controlled clinical trial utilizing two isocaloric meal plans utilizing either a high protein-enriched (HP) or a standard protein (SP) meal replacement in an outpatient weight loss program. Subjects/methods: 100 obese men and women over 30 years of age with a body mass index (BMI) between 27 to 40 kg/m(2) were randomized to one of two isocaloric weight loss meal plans 1). HP group: providing 2.2 g protein/kg of lean body mass (LBM)/day or 2). SP group: providing 1.1 g protein/kg LBM/day. Meal replacement (MR) was used twice daily (one meal, one snack) for 3 months and then once a day for 9 months. Body weight, lipid profiles, liver function, renal function and bone density were measured at baseline and 12 months. Results: Seventy subjects completed the study. Both groups lost weight (HP -4.29 +/- 5.90 kg vs. SP -4.66 +/- 6.91 kg, p < 0.01) and there was no difference in weight loss observed between the groups at one year. There was no significant change noted in liver function [AST (HP -2.07 +/- 10.32 U/L, p = 0.28; SP 0.27 +/- 6.67 U/L, p = 0.820), ALT (HP -1.03 +/- 10.08 U/L, p = 0.34; SP -2.6 +/- 12.51 U/L, p = 0.24), bilirubin (HP 0.007 +/- 0.33, U/L, p = 0.91; SP 0.07 +/- 0.24 U/L, p = 0.120), alkaline phosphatase (HP 2.00 +/- 9.07 U/L, p = 0.240; SP -2.12 +/- 11.01 U/L, p = 0.280)], renal function [serum creatinine (HP 0.31 +/- 1.89 mg/dL, p = 0.380; SP -0.05 +/- 0.15 mg/dL, p = 0.060), urea nitrogen (HP 1.33 +/- 4.68 mg/dL, p = 0.130; SP -0.24 +/- 3.03 mg/dL, p = 0.650), 24 hour urine creatinine clearance (HP -0.02 +/- 0.16 mL/min, p = 0.480; SP 1.18 +/- 7.53 mL/min, p = 0.400), and calcium excretion (HP -0.41 +/- 9.48 mg/24 hours, p = 0.830; SP -0.007 +/- 6.76 mg/24 hours, p = 0.990)] or in bone mineral density by DEXA (HP 0.04 +/- 0.19 g/cm(2), p = 0.210; SP -0.03 +/- 0.17 g/cm(2), p = 0.320) in either group over one year. Conclusions: These studies demonstrate that protein-enriched meals replacements as compared to standard meal replacements recommended for weight management do not have adverse effects on routine measures of liver function, renal function or bone density at one year. Clinicaltrial. gov: NCT01030354.