Psychological Aspects and Patients Compliance to Restricted-protein Regimens in Chronic Kidney Disease (KetoPsy)

Anemia Working Group Romania

Status: Unknown

Conditions: Psychological Characteristics Involved in Dietary Compliance

Study type: Observational

Funder types: Other

Identifiers

NCT02345759

AWG 5/2014

Details and patient eligibility

About

Dietary management of CKD patients proved important to postpone dialysis. Long-term compliance to protein-restricted diets was discussed. Psychological aspects involved in certain dietary behaviour have never been studied.

Full description

The interest in dietary management resurged, since the high prevalence of revealed a major impact not only on morbidity, mortality, social activities and patients' quality of life, but also on health budget.

Although protein-restricted diets are used for more than a century in patients with advanced Chronic Kidney Disease (CKD), their efficacy and safety is still debatable. Enough evidence has being accumulated on their role in postponing dialysis initiation in compliant patients. Consequently, the long-term compliance to the diet is discussed. Psychological aspects of compliant patients are certainly involved. Identification of certain psychological predictors of dietary compliance could help to select the patients who are more likely to be compliant and therefore to benefit from such an intervention. Moreover, short-term or long-term psychological intervention addressing these factors could increase patient long-term compliance.

Accordingly, we are aiming to evaluate psychological characteristics of Chronic Kidney Disease patients in relation with their compliance to protein-restricted regimens.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients
• stage 4+ CKD
• good nutritional status (Subjective Global Assessment score A/B and serum albumin ≥3.5 g/dL)
• declared potentially good compliance with a low protein diet and agreed to follow the monitoring schedule are considered for the program

Exclusion criteria

• poorly controlled arterial blood pressure (≥145/85 mm Hg)
• uncontrolled diabetes mellitus
• other relevant comorbidities (heart failure, active hepatic disease, digestive diseases with malabsorption, inflammation/anti-inflammatory therapy)
• uremic complications (pericarditis, polyneuropathy)
• feeding inability (anorexia, nausea)

Trial design

120 participants in 2 patient groups

Keto-diet group

Description:

Vegetarian very low protein regimen (0.3 g proteins/kg ideal body weight per day) supplemented with ketoanalogues of essential amino acids (Ketosteril®, Fresenius Kabi, Bad Homburg, Germany), 1 capsule for every 5 kg of ideal dry body weight per day.

Conventional LPD group

Description:

0.6 g/kg per day, including high biological value proteins