Clinical efficacy and feasibility of whey protein isolates supplementation in malnourished peritoneal dialysis patients

A multicenter, parallel, open-label randomized controlled trial

Sharmela Sahathevan, Chee Hee Se, See Hoe Ng, Ban Hock Khor, Karuthan Chinna, Bak Leong Goh, Abdul Halim Abdul Gafor, Sunita Bavanandan, Ghazali Ahmad, Tilakavati Karupaiah

Research output: Contribution to journalArticle

2 Citations (Scopus)

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 languageEnglish
Pages (from-to)68-77
Number of pages10
JournalClinical Nutrition ESPEN
Volume25
DOIs
Publication statusPublished - 1 Jun 2018

Fingerprint

Peritoneal Dialysis
Randomized Controlled Trials
Continuous Ambulatory Peritoneal Dialysis
Urea
Weights and Measures
Malnutrition
Dialysis
Serum
Serum Albumin
Registries
Whey Proteins
Clinical Trials
Skin
Population
Proteins

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 journalArticle

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. / Clinical efficacy and feasibility of whey protein isolates supplementation in malnourished peritoneal dialysis patients : A multicenter, parallel, open-label randomized controlled trial. In: Clinical Nutrition ESPEN. 2018 ; Vol. 25. pp. 68-77.
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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).",
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author = "Sharmela Sahathevan and Se, {Chee Hee} and Ng, {See Hoe} and Khor, {Ban Hock} and Karuthan Chinna and Goh, {Bak Leong} and {Abdul Gafor}, {Abdul Halim} and Sunita Bavanandan and Ghazali Ahmad and Tilakavati Karupaiah",
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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

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