Effect of high calorie high protein diet versus high calorie,glomerular filtration rate (GFR) based protein intake in non-obese advanced HF patients will be assessed. In this regard, protein intake impact will be measured on muscle mass, physical performance and renal function as main outcome. Rehospitalization, quality of life, depression an inflammatory status are second endpoints.
Patient examinations: Baseline data will be gathered on demographic and clinical characteristics, medical history, treatments and medications. Before initiating intervention, individuals will be assessed for anemia and 25 (OH) D2 and electrolytes status. Any insufficiency or imbalance will be corrected by drug therapy or supplementation. At baseline and at all visits, half or one month intervals, routine laboratory tests for heart failure patients (including Complete blood count (CBC), electrolytes status, glucose, albumin, cholesterol, triglyceride, blood urea nitrogen (BUN), C-reactive Protein (CRP),creatinine, uric acid, ferritin, 25 (OH) D, B-type natriuretic peptide (BNP), thyroid function, Prealbumin, urine analysis), appetite status and anthropometric measurements (weight, Hip and waist circumference) will be performed. At baseline and by the end of month 6, body composition, muscle mass, hand grip strength, Short Physical Performance Battery (SPPB), plasma lactate and interleukin 6 (IL-6), GFR, depression status and quality of life will be assessed. Follow up duration will be one year for measuring readmission and mortality rate. If a study participant did not attend a visit, a staff of randomized clinical trial (RCT) center will attempt to reach her/him, her/his designated friend or family member by phone call.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
100
For each participant, weighed food records of 3 consecutive days will be analyzed for estimation of calorie and macronutrient intake and dietary preferences. To make sure good compliance, diets will be developed regarding patient's dietary habits and preferences individually. High calorie (30-35 kcal/kg Ideal body weight) diets including 6-8 small meals will be formulated. Intervention group will receive high protein diet as recommended to preserve muscle mass (1.2-1.5 g/kg IBW). Comparison group will receive protein based on GFR to preserve renal function. For older adults (\>65 years) protein content of diet will be as recommended by the international study group to review dietary protein needs with aging (PROT-AGE). In subjects with lower intake of protein, carbohydrate will be substituted. Both group will receive low fat diet.
Change from baseline muscle mass at 6 months
muscle mass will be assessed by Dual-Energy X-Ray Absorptiometry (DEXA)
Time frame: At baseline and after 6 months
Change from baseline depression status at 6 months
Cardiac Depression Scale (CDS) questionnaire
Time frame: At Baseline and after 6 months
Change from baseline appetite status at 6 months
Simplified Nutritional Appetite Questionnaire (SNAQ)
Time frame: At baseline, in each visit up to 6 months
Change from baseline quality of life status at 6 months
Kansas City Cardiomyopathy Questionnaire
Time frame: AT baseline and after 6 months
Mortality rate
Mortality occurrence
Time frame: Up to 1 year
Rehospitalization
Frequency of hospital admission in 1 year
Time frame: Number of hospital admission will be recorded from date of intervention initiation until 1 year
Change from baseline kidney function at 6 months
Glomerular filtration rate (GFR) (WIZARD® Automatic Gamma Counter) will be performed
Time frame: At baseline and after 6 months
Change from baseline handgrip strength at 6 months
Handgrip strength will be measured using hand grip dynamometer
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Time frame: At baseline and after 6 months
Change from baseline physical performance at 6 months
SPPB score will be measured for physical performance assessment which includes: gait speed (timed 4-metre walk), sit-to-stand time (timed test of five chair rises), and standing balance (side-by-side stand, tandem and semi-tandem positions)
Time frame: At baseline and after 6 months