Background
Chronic kidney disease (CKD): an example of a highly complex, life-long disease
Chronic kidney disease in the new millennium: why is it difficult to measure progression?
Low-protein diets in CKD: why is the evidence not evident enough?
Study | Comparators | N and groups | Main results | Limitations | Other comments |
---|---|---|---|---|---|
Klahr S et al., N Engl J Med. 1994 (MDRD) [39] | LPD vs No diet; LPD vs LPD | Study 1, 585 patients: usual diet: 1.3 g/Kg/day LPD: 0.58 Study 2, 255 patients on or vLPD (plus BP control) | moderate CKD: small benefit LPDs. severe CKD: no difference in ESRD progression on LPDs and vLPD | Highly complex study. The results are given as ITT; however PP analysis shows a significant effect of LPDs, thus highlighting the role of compliance. | The largest RCT on LPDs leading to inconclusive results: it may be also read as measure of the limitations of RCTs analysed as ITT, due to compliance issues |
Brunori G, et al. Am J Kidney Dis. 2007 [53] | vLPDs versus dialysis in the elderly (stage 5) | 56 patients in each group (296 screened) | vLPDs are effective in delaying the need for dialysis without increasing mortality | Only about 30 % of the initial population accepted being randomised. No information on the follow-up and outcomes of the excluded patients. | The only study randomizing dialysis vs vLPDs; highly relevant even if randomizing such intrusive issues may be perceived as “unethical” |
Cianciaruso B, et al. Nephrol Dial Transplant 2008 [57] | 0.55 LPD and 0.8 LPD in CKD stage 4–5 | 200 patients on 0.55 diet, 192 on 0.8 diet (screened 753; initial randomization: 423 pts) | LPD at 0.55 g/kg/day guarantees better metabolic control than a 0.8 diet. | Relatively low compliance in the 0.55 study group (compliant patients: 27 % in the 0.55- Group and 53 % in the 0.8-Group), thus blunting the conclusions. At present 0.8 should be a “normal protein” | Very large study, on two “moderately restricted LPDs: it shows that even within the “moderate restriction range” the lower the better, without risk of malnutrition |
Garneata L et al. JASN 2016 [59] | vLPD vs LPD in CKD stages 4–5 | vLPD: 104 patients LPD: 103 patients (Screened 1413; non compliance is the main reason for non being randomised) | Better correction of metabolic abnormalities and lower need for dialysis in the vLPD cohort. | Only 14 % of screened patients were randomized. Optimal compliance is a requisite for randomization, indirectly suggesting that these diets are an option for relatively few CKD patients. | The largest recent RCT targeted on supplemented vLPDs vs LPDs. Underlines the importance of vegan diet and of supplementation. |
Diet is not a drug: the “low-protein menu” in CKD
Type of diet | Protein restriction (g/Kg/bw) | Main features | “Best patients” | Main advantages | Main disadvantages | Personalization; main approach |
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“Traditional” | 0.6–0.8 g/Kg/day; mixed proteins | Modulated upon quantity of usual food; in moderate and hot climates, traditional cuisine is more plant based, and returning to the roots may be useful | Mediterranean- Asian origin; careful with preparation, cook their own food | A very natural approach, adapted to all settings, doesn’t require special food, | Demanding: requires special attention to quantity and quality of food | Large room for personalization, discovery and rediscovery of traditional cuisine; flexible; Educational approach is needed. |
Vegan | 0.6–0.8 g/Kg/day; vegetable proteins | Unrestricted vegan diets are usually in the 0.7–0.9 g/Kg/day protein intake range; due to the different bioavailability, a 0.7 diet roughly corresponds to a 0.6 mixed protein diet | “New age”, young people who want to avoid supplements or special food; Cook their own food | A “trendy” approach, due to the diffusion of veganism in the western world; a natural diet that may have other favourable effects on health | Demanding: requires special attention to quality of food and to the integration of legumes and cereals. Risk of B12, vit D and iron deficits | Quite good room for personalization, especially for not becoming boring; relatively flexible; Educational approach is needed. |
Vegan supplemented | 0.6 g/Kg/day; vegetable proteins, supplemented with a mixture of amino- and keto-acids | Based upon forbidden (animal origin) and allowed (all other) food. Animal-derived food is allowed only in “free meals” | young working people, who want a simple diet, easily adapted to any situation | A simplified approach: supplements avoid the need to integrate legumes and cereals, thus reducing the risk of nutritional deficits | Adding pills to the usual, often already demanding drug list. Expensive where supplements are not supplied by the health care system | Some room for personalization, especially for not becoming boring; relatively flexible; Educational approach has to be combined with a prescription approach (supplements) |
Protein-free food | 0.6 g/Kg/day; mixed proteins | Protein-free pasta, bread and other carbohydrates | Mediterranean- Asian origin; elderly people who do not want to change their habits | May allow a reduction of proteins without changing eating habits | The protein-free food tastes different and may not be “tasty”, it is expensive where foods are not supplied by the health care system. The food has to be prepared separately | Large room for personalization, may preserve previous habits in Mediterranean settings; relatively flexible; Prescription approach for protein-free food. |
Very low-protein supplemented (with or without protein-free food) | 0.3 g/Kg/day; vegetable proteins, supplemented with a mixture of amino- and keto-acids; higher dose as with the 0.6 diet | Based upon forbidden (animal origin) and allowed (all other) food. Animal-derived food is allowed only in “free meals” (usually no more than 1 per week) | Highly motivated patients who do not want to start dialysis or are waiting for transplantation | The most effective approach for delaying dialysis start | Adding many pills to the usual, often already demanding drug list. Very difficult if protein- free food is not available. Expensive where supplements and protein-free foods are not supplied by the health care system | Scarce room for personalization; not flexible; Educational approach has also to be focused on compliance; has to be combined with a prescription approach (supplements). |