Abstract
Background and aims: Poor dietary intake is commonly associated with malnutrition in the dialysis population and oral nutritional supplementation is strategized to redress dietary inadequacy. Knowledge on clinical efficacy of whey protein supplementation (WPS) as an option to treat malnutrition in continuous ambulatory peritoneal dialysis (CAPD) patients is limited. Methods: This multicenter, parallel, open-label, randomized controlled trial investigated the clinical efficacy of WPS in 126 malnourished CAPD patients with serum albumin <40 g/L and body mass index (BMI) <24 kg/m2. Patients randomized to the intervention group (IG, n = 65) received protein powder (27.4 g) for 6 months plus dietary counseling (DC) while the control group (CG, n = 61) received DC only. Anthropometry, biochemistry, malnutrition-inflammation-score (MIS), dietary intake inclusive of dialysate calories, handgrip strength (HGS) and quality of life (QOL) were assessed at baseline and 6 months. Clinical outcomes were assessed by effect size (Cohen's d) comparisons within and between groups. Results: Seventy-four patients (n = 37 per group) completed the study. Significantly more IG patients (59.5%) achieved dietary protein intake (DPI) adequacy of 1.2 g/kg per ideal body weight (p < 0.001) compared to CG (16.2%) although difference in the adequacy of dietary energy intake between groups was non-significant (p > 0.05). A higher DPI paralleled significant increases in serum urea (mean Δ: IG = +2.39 ± 4.36 mmol/L, p = 0.002, d = 0.57 vs CG = −0.39 ± 4.59 mmol/L, p > 0.05, d = 0.07) and normalized protein catabolic rate, nPCR (mean Δ: IG = +0.11 ± 0.14 g/kg/day, p < 0.001, d = 0.63 vs CG = +0.001 ± 0.17 g/kg/day, p > 0.05, d = 0.09) for IG compared to CG patients. Although not significant, comparison for changes in post-dialysis weight (mean Δ: +0.64 ± 1.16 kg vs +0.02 ± 1.36 kg, p = 0.076, d = 0.58) and mid-arm circumference (mean Δ: +0.29 ± 0.93 cm vs −0.12 ± 0.71 cm, p = 0.079, d = 0.24) indicated trends favoring IG vs CG. Other parameters remained unaffected by treatment comparisons. CG patients had a significant decline in QOL physical component (mean Δ = −6.62 ± 16.63, p = 0.020, d = 0.47). Using changes in nPCR level as a marker of WPS intake within IG, ‘positive responders’ achieved significant improvement in weight, BMI, skinfold measures and serum urea (all p < 0.05), while such changes within ‘negative responders’ were non-significant (all p > 0.05). Conclusion: A single macronutrient approach with WPS in malnourished CAPD patients was shown to achieve DPI adequacy and improvements in weight, BMI, skin fold measures, serum urea and nPCR level. Clinical trial registry: www.clinicaltrials.gov (NCT03367000).
| Original language | English |
|---|---|
| Pages (from-to) | 68-77 |
| Number of pages | 10 |
| Journal | Clinical Nutrition ESPEN |
| Volume | 25 |
| DOIs | |
| Publication status | Published - 1 Jun 2018 |
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Keywords
- Malnutrition
- Nutritional status
- Peritoneal dialysis
- Protein supplementation
- Whey protein
ASJC Scopus subject areas
- Endocrinology, Diabetes and Metabolism
- Nutrition and Dietetics
Cite this
Clinical efficacy and feasibility of whey protein isolates supplementation in malnourished peritoneal dialysis patients : A multicenter, parallel, open-label randomized controlled trial. / Sahathevan, Sharmela; Se, Chee Hee; Ng, See Hoe; Khor, Ban Hock; Chinna, Karuthan; Goh, Bak Leong; Abdul Gafor, Abdul Halim; Bavanandan, Sunita; Ahmad, Ghazali; Karupaiah, Tilakavati.
In: Clinical Nutrition ESPEN, Vol. 25, 01.06.2018, p. 68-77.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Clinical efficacy and feasibility of whey protein isolates supplementation in malnourished peritoneal dialysis patients
T2 - A multicenter, parallel, open-label randomized controlled trial
AU - Sahathevan, Sharmela
AU - Se, Chee Hee
AU - Ng, See Hoe
AU - Khor, Ban Hock
AU - Chinna, Karuthan
AU - Goh, Bak Leong
AU - Abdul Gafor, Abdul Halim
AU - Bavanandan, Sunita
AU - Ahmad, Ghazali
AU - Karupaiah, Tilakavati
PY - 2018/6/1
Y1 - 2018/6/1
N2 - Background and aims: Poor dietary intake is commonly associated with malnutrition in the dialysis population and oral nutritional supplementation is strategized to redress dietary inadequacy. Knowledge on clinical efficacy of whey protein supplementation (WPS) as an option to treat malnutrition in continuous ambulatory peritoneal dialysis (CAPD) patients is limited. Methods: This multicenter, parallel, open-label, randomized controlled trial investigated the clinical efficacy of WPS in 126 malnourished CAPD patients with serum albumin <40 g/L and body mass index (BMI) <24 kg/m2. Patients randomized to the intervention group (IG, n = 65) received protein powder (27.4 g) for 6 months plus dietary counseling (DC) while the control group (CG, n = 61) received DC only. Anthropometry, biochemistry, malnutrition-inflammation-score (MIS), dietary intake inclusive of dialysate calories, handgrip strength (HGS) and quality of life (QOL) were assessed at baseline and 6 months. Clinical outcomes were assessed by effect size (Cohen's d) comparisons within and between groups. Results: Seventy-four patients (n = 37 per group) completed the study. Significantly more IG patients (59.5%) achieved dietary protein intake (DPI) adequacy of 1.2 g/kg per ideal body weight (p < 0.001) compared to CG (16.2%) although difference in the adequacy of dietary energy intake between groups was non-significant (p > 0.05). A higher DPI paralleled significant increases in serum urea (mean Δ: IG = +2.39 ± 4.36 mmol/L, p = 0.002, d = 0.57 vs CG = −0.39 ± 4.59 mmol/L, p > 0.05, d = 0.07) and normalized protein catabolic rate, nPCR (mean Δ: IG = +0.11 ± 0.14 g/kg/day, p < 0.001, d = 0.63 vs CG = +0.001 ± 0.17 g/kg/day, p > 0.05, d = 0.09) for IG compared to CG patients. Although not significant, comparison for changes in post-dialysis weight (mean Δ: +0.64 ± 1.16 kg vs +0.02 ± 1.36 kg, p = 0.076, d = 0.58) and mid-arm circumference (mean Δ: +0.29 ± 0.93 cm vs −0.12 ± 0.71 cm, p = 0.079, d = 0.24) indicated trends favoring IG vs CG. Other parameters remained unaffected by treatment comparisons. CG patients had a significant decline in QOL physical component (mean Δ = −6.62 ± 16.63, p = 0.020, d = 0.47). Using changes in nPCR level as a marker of WPS intake within IG, ‘positive responders’ achieved significant improvement in weight, BMI, skinfold measures and serum urea (all p < 0.05), while such changes within ‘negative responders’ were non-significant (all p > 0.05). Conclusion: A single macronutrient approach with WPS in malnourished CAPD patients was shown to achieve DPI adequacy and improvements in weight, BMI, skin fold measures, serum urea and nPCR level. Clinical trial registry: www.clinicaltrials.gov (NCT03367000).
AB - Background and aims: Poor dietary intake is commonly associated with malnutrition in the dialysis population and oral nutritional supplementation is strategized to redress dietary inadequacy. Knowledge on clinical efficacy of whey protein supplementation (WPS) as an option to treat malnutrition in continuous ambulatory peritoneal dialysis (CAPD) patients is limited. Methods: This multicenter, parallel, open-label, randomized controlled trial investigated the clinical efficacy of WPS in 126 malnourished CAPD patients with serum albumin <40 g/L and body mass index (BMI) <24 kg/m2. Patients randomized to the intervention group (IG, n = 65) received protein powder (27.4 g) for 6 months plus dietary counseling (DC) while the control group (CG, n = 61) received DC only. Anthropometry, biochemistry, malnutrition-inflammation-score (MIS), dietary intake inclusive of dialysate calories, handgrip strength (HGS) and quality of life (QOL) were assessed at baseline and 6 months. Clinical outcomes were assessed by effect size (Cohen's d) comparisons within and between groups. Results: Seventy-four patients (n = 37 per group) completed the study. Significantly more IG patients (59.5%) achieved dietary protein intake (DPI) adequacy of 1.2 g/kg per ideal body weight (p < 0.001) compared to CG (16.2%) although difference in the adequacy of dietary energy intake between groups was non-significant (p > 0.05). A higher DPI paralleled significant increases in serum urea (mean Δ: IG = +2.39 ± 4.36 mmol/L, p = 0.002, d = 0.57 vs CG = −0.39 ± 4.59 mmol/L, p > 0.05, d = 0.07) and normalized protein catabolic rate, nPCR (mean Δ: IG = +0.11 ± 0.14 g/kg/day, p < 0.001, d = 0.63 vs CG = +0.001 ± 0.17 g/kg/day, p > 0.05, d = 0.09) for IG compared to CG patients. Although not significant, comparison for changes in post-dialysis weight (mean Δ: +0.64 ± 1.16 kg vs +0.02 ± 1.36 kg, p = 0.076, d = 0.58) and mid-arm circumference (mean Δ: +0.29 ± 0.93 cm vs −0.12 ± 0.71 cm, p = 0.079, d = 0.24) indicated trends favoring IG vs CG. Other parameters remained unaffected by treatment comparisons. CG patients had a significant decline in QOL physical component (mean Δ = −6.62 ± 16.63, p = 0.020, d = 0.47). Using changes in nPCR level as a marker of WPS intake within IG, ‘positive responders’ achieved significant improvement in weight, BMI, skinfold measures and serum urea (all p < 0.05), while such changes within ‘negative responders’ were non-significant (all p > 0.05). Conclusion: A single macronutrient approach with WPS in malnourished CAPD patients was shown to achieve DPI adequacy and improvements in weight, BMI, skin fold measures, serum urea and nPCR level. Clinical trial registry: www.clinicaltrials.gov (NCT03367000).
KW - Malnutrition
KW - Nutritional status
KW - Peritoneal dialysis
KW - Protein supplementation
KW - Whey protein
UR - http://www.scopus.com/inward/record.url?scp=85045732809&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85045732809&partnerID=8YFLogxK
U2 - 10.1016/j.clnesp.2018.04.002
DO - 10.1016/j.clnesp.2018.04.002
M3 - Article
C2 - 29779821
AN - SCOPUS:85045732809
VL - 25
SP - 68
EP - 77
JO - Clinical Nutrition ESPEN
JF - Clinical Nutrition ESPEN
SN - 2405-4577
ER -