BACKGROUND Chronic kidney disease (CKD) affects up to 15% of the global population and is characterized by progressive loss of kidney function. Both KDIGO 2024 and KDOQI 2020 guidelines recommend very low protein diets (VLPD) supplemented with keto acid analogs (KAs) for patients at risk of progression, yet no integrated, turn-key dietary program had demonstrated measurable improvement in estimated glomerular filtration rate (eGFR) trajectories prior to this study. The Kidneyhood dietary program (KD) is a standardized, integrated VLPD combining Albutrix (a magnesium-based KA with <200 mg nitrogen per daily dose) and Microtrix multivitamin, designed to meet all recommended dietary allowances while minimizing nitrogen load on diseased kidneys. METHODS Retrospective, longitudinal analysis of 31 CKD stage 3–4 patients with a minimum of six months' consistent KD program use. Email recruitment targeted patients with verified reorder history. HIPAA-compliant data collection was conducted via a secure platform; all participants provided informed consent and were assigned blinded study IDs. Laboratory data were collected at baseline, six months, and one year. Primary endpoints: eGFR, blood urea nitrogen (BUN), and serum creatinine — the same endpoints used in kidney disease drug approval trials. Secondary endpoints: serum albumin and blood glucose. Analysis used one-way ANOVA with post hoc Tukey comparisons. Effect sizes were calculated using Cohen's d. Results were compared against a published historical benchmark of eGFR decline in untreated CKD (Garofalo et al., Am J Kidney Dis, 2024). RESULTS Mean eGFR increased from 33.2 mL/min/1.73 m² at baseline to 41.5 at six months and 43.1 at one year (ANOVA F=3.686, p=.029). Post hoc analysis confirmed a significant increase from baseline to one year (mean difference +9.9, p=.036, Tukey-corrected). 80% of participants improved eGFR at both time points. Mean BUN decreased from 33.9 mg/dL at baseline to 18.1 mg/dL at six months and 19.7 mg/dL at one year (ANOVA F=9.433, p<0.001, η²=0.199). Post hoc: baseline to six months mean difference 15.8 (p<.001, Cohen's d=1.04); baseline to one year mean difference 14.2 (p=.002, Cohen's d=0.89). 92% of participants reduced BUN at six months; over 80% achieved normal BUN levels. Serum creatinine decreased from 2.19 to 1.74 mg/dL (ANOVA p=.028). 86.2% of participants reduced creatinine at six months. Blood glucose showed no significant change (p=.957, η²=0.001), confirming dietary safety for diabetic and pre-diabetic patients. Serum albumin remained stable (p=.940), confirming nutritional adequacy on the VLPD. The mean eGFR change of +9.9 mL/min/1.73 m² was statistically significantly greater than the published historical CKD decline rate of approximately -5 mL/min/1.73 m² per year (t=6.951, df=173, p<0.001, Cohen's d≈0.93). Patient adherence was 75%. CONCLUSIONS The Kidneyhood integrated VLPD + keto acid analog program demonstrated statistically significant improvements in eGFR, BUN, and serum creatinine over one year in CKD stage 3–4 patients. The BUN reduction effect size (Cohen's d=1.04 at six months) is large by conventional standards. This is the first dietary program to document measurable improvement in eGFR and achievement of normal BUN levels in the majority of participants. The program's standardized, integrated approach achieved 75% adherence — addressing a primary limitation of prior low-protein diet studies. Study limitations include small sample size, lack of randomized control, and retrospective design. Larger randomized controlled trials are warranted. "This study was conducted in accordance with the Declaration of Helsinki. All participants provided informed consent. Data was collected via HIPAA-compliant platform with de-identified participant records."
Baran et al. (Sun,) studied this question.