EFFECT OF NUTRITIONAL INTERVENTION ON MALNUTRITION INDICATORS IN PATIENTS ON HAEMODIALYSIS

EFFECT OF NUTRITIONAL INTERVENTION ON MALNUTRITION INDICATORSIN PATIENTS ON HAEMODIALYSIS

Linda Grace Roy1, Manjunath S. Shetty2, Asna Urooj1

1Department of Studies in Food Science and Nutrition, University of Mysore, Mysore-570 006, Karnataka, India2JSS Hospital, Nephrology, Mysore-570 015, Karnataka, India

Roy L.G., ShettyM.S., Urooj A. (2013). Effect of nutritional intervention onmalnutrition indicators in patients on haemodialysis.

Journal of Renal Care 39(1), 39–46.

S U M M A R YObjective: To formulate a nutrient supplement using low cost, commonly available food ingredients and test its efficacy on

various nutritional parameters in haemodialysis (HD) subjects.

Design: Prospective intervention study.

Subjects: 15 subjects who did not have diabetes were recruited for the study. The subjects served as self controls.

Approach: The subjects received a multi-nutrient formulation for a period of 3 months. Somatic status [weight, mid upper

arm circumference (MUAC), mid upper arm muscle circumference (MUAMC), waist and hip measurements], biochemical

parameters [blood urea nitrogen (BUN) , total iron binding capacity (TIBC),serum levels of creatinine, albumin, triglycerides,

sodium, potassium, calcium, phosphorus and high sensitive C-reactive protein(HsCRP)], dietary intake and malnutrition

inflammation score (MIS) were assessed.

Results: Significant increments (P � 0.01) in anthropometric measurements. Significant increases (P � 0.01) in Hb, BUN,

serum creatinine, albumin and total protein and a significant decrease (P � 0.01) in HsCRP and MIS were observed at the

end of the study. An increase in baseline food/nutrient intake was also observed.

Conclusion: Nutritional supplementation designed for haemodialysis, improved their nutritional status in the short term

study.

KEY WORDS Haemodialysis � Haemoglobin � Nutrition/malnutrition

INTRODUCTIONSeveral studies have indicated that patients undergoing

haemodialysis (HD) show signs of wasting and malnutrition

(Fouque et al. 2008; Cano et al. 2009). The reasons may be

related to inadequate dietary intake (due to physical disability,

financial constraints and dietary constraints), loss of nutrients

during dialysis, intercurrent illness and altered protein energy

metabolism. Decreases in biochemical and anthropometric

variables are usually seen in patients on HD with a limited food

intake (Fedje et al. 1996).

There are several objective methods for assessing the nutritional

status of patients on HD. These includes anthropometric and

biochemical measurements, dietary intake (using 24-hour recall,

food frequency) and use of a malnutrition inflammation score

(MIS) which is an inexpensive and easy method based on various

clinical observations and grading scales calculated from a brief

history and physical examination (Kopple 1994; Kalantar-Zadeh

et al. 2001; Pifer et al. 2002; Shinaberger et al. 2006). The

components of MIS are weight change, dietary intake, gastro-

intestinal symptoms, functional capacity, co-morbidity including

number of years of dialysis therapy, subcutaneous fat, signs of

muscle wasting, bodymass index (BMI), serum albumin level and

B I O D A T A

Linda Grace Roy is a Researchcandidate currently working on herPhD. She is working under thesupervision of her co-author,Asna Urooj.

Asna Urooj has a PhD and is Professor at the Departmentof Food Science &Nutrition at the University ofMysore, India.She is the coordinator of the University Grants CommisionSpecial Assistance program, member of the Board ofstudies of several Universities including University of Mysore.She is the Member Secretary of Institutional Human EthicsCommittee and also the editor of Journal of Food Science& Technology (Springer).

CORRESPONDENCE

Linda Grace RoyUniversity of Mysore, Food Science and NutritionMysore, Karnataka, IndiaTel.: þ91 821 2419632Fax: þ91 821 [email protected]

© 2013 European Dialysis and Transplant Nurses Association/European Renal Care Association Journal of Renal Care 2013 39

O R I G I N A L R E S E A R C H

TIBC. The 10 components, each have four levels of severity, from

0 (normal) to 3 (severely abnormal). The sum of all 10 com-

ponents ranges from 0 (normal) to 30 (severely malnourished).

Several studies have shown that the effectiveness of oral

nutrition supplements in the treatment ofmalnutrition in people

with End Stage Renal Disease (ESRD) (Beutler et al. 1997;

Sharma et al. 2002). Boudville et al. (2003) showed that the

addition of an oral nutrition supplement resulted in an increase

in mean caloric and protein intake in those undergoing HD.

Similarly Dare et al. (1997) reported that the use of a disease-

specific supplement in patients on HD caused an increase in

various biochemical parameters such as serum albumin,

creatinine, total protein, cholesterol, triglycerides and BUN

levels. Sharma et al. (2002) showed a significant increase in

various nutritional parameters with the use of low cost, home-

prepared high calorie and protein blend (enteral) in patients

on HD.

Although, renal specific supplements are available, their limited

usage is due to their high cost especially when considering the

economic conditions of patients living in India. Therefore it

becomes necessary to formulate a disease-specific nutrient

supplement which is affordable by everyone.

This study explores the possibility of formulating a low cost

renal specific formulation, that utilises common food sources

such as cereals and pulses, which predominantly constitute

the Indian diet. This study will also evaluate the effects of

this formulation on the dietary and clinical status of patients

on HD.

MATERIALS AND METHODSFORMULATION OF ‘NUTRENE’

A multi-purpose composite flour ‘NUTRENE’ was formulated

by the authors of the study using locally available ingredients

suitable for patients on HD (Table 1). Soy protein isolate

was used as a source of high biological value protein and

was procured from Solae Company Private Limited,

Gurgaon, Haryana, India. Dehydrated carrot (Daucus carota)

at 5% level was added to the flour mix as a natural source

of b-carotene. The selected food items were procured as

flours from local market, roasted and mixed to formulate

‘NUTRENE’.

‘NUTRENE’ was used to prepare cookies by substituting 30%

with white flour, enriched with pomegranate leaf powder (PM;

3%). They were prepared by the following method. Sugar (1 kg)

and fat (1 kg) were creamed for three to fiveminutes in a Hobart

mixer. The water containing sodium chloride (10 g) was added

to the above cream and mixed for five minutes to obtain an

homogenous dough. The formulation (2 kg) was sieved twice

with baking powder (10 g) and cardamom powder (5 g) and

mixed for three minutes. The dough was moulded into circular

shapes and placed on an aluminium tray, baked at 1508C for 20

minutes.

Both ‘NUTRENE’ and cookies were packed in airtight containers

and stored in refrigerated conditions for chemical analysis.

ANALYSIS

The formulation ‘NUTRENE’ and cookies were analysed for

moisture, ash, protein and crude fat by the Association of

Official Analytical Chemists (AOAC) method (2005). Calcium,

sodium and potassium were analysed by Atomic absorption

spectroscopy, total iron by the colorimetric method using a,

a-bipyridylmethod (AOAC2005) total phosphorus as per Taussky

and Shorr method (1953). In vitro iron bio-accessibility and

protein digestibility (IVPD) were determined by the methods of

Luten et al. (1996) and Akeson& Stahmann (1964), respectively.

% IVPD was calculated using the formula:

% IVPD ¼ digested proteins� 100

total proteins

PATIENTS AND METHODS

A preliminary study was undertaken to investigate the degree of

malnourishment and nutritional needs of patients on HD who

did not have diabetes (n ¼ 72). Patients were recruited from

three major hospitals in Mysore city. Their biochemical

measures, dietary intake and MIS were assessed. It was found

that all the measurements were below standard ranges and the

Ingredients Amount (%)

Oryza sativa 33Sorghum vulgare 22Maranta arundinacea 15Eleusine coracana 10Phaseolus aureus Roxb 12Glycine max Merr 3Sago 5Carrot powder 5

Table 1: Composition of NUTRENE.

40 Journal of Renal Care 2013 © 2013 European Dialysis and Transplant Nurses Association/European Renal Care Association

Roy et al.

degree of malnourishment was higher when compared with

subjects in other studies. The patients’ nutrient intake (energy,

protein and micronutrients such as iron, calcium, phosphorus,

potassium) was also below recommended levels. According to

the MIS classification, 72% were mild-moderately malnour-

ished, 15% were severely malnourished and 13% were in the

normal category. From this population, a sub sample of 15

subjects (10 males and 5 females) undergoing HD was included

for this prospective nutrition intervention study.

The inclusion criteria for the patients were:

1. more than 18 years of age,

2. receiving HD at least two times/week,

3. clinically stable and

4. similar nutrient intakes in terms of energy and protein.

Patients who met the study criteria signed a consent form. The

study protocol was approved by the university and hospital

ethics committee.

All patients received ‘NUTRENE’ as a powder (50 g) which was

consumed as rotis (flat Indian bread) and ‘NUTRENE’ cookies

(3 no.) for a period of three months without any modifications

in their daily diet. The supplementation was intended to meet

at least one-third of their nutritional requirements.

ASSESSMENT

Dietary intake

Dietary intakes were recorded using a 24-hour diet recall system

on three different days including a weekend, at baseline and at

the end of the three-month study. Nutrient intake of macro-

nutrients such as energy and protein and micronutrients as

sodium, potassium, calcium and phosphorus were calculated

using standard food composition tables (Gopalan et al. 1994).

Anthropometric measurements

Height, weight, mid upper arm circumference (MUAC), waist

and hip measurements and skinfold thickness (biceps, triceps,

subscapular and iliac crest) were measured pre-dialysis at

baseline and after each month during the study (Chumlea et al.

1997). The four site skinfold thicknesses were measured using

skinfold calipers. These measurements were performed by the

same observer on the side of the body that did not have vascular

access. Indices like BMI, ideal body weight (IBW) and mid upper

armmuscle circumference (MUAMC) andwaist to hip ratio were

calculated (Chumlea et al. 1997). All the measurements and

indices were compared with standard values for Asian Indians

(Misra et al. 2009; Kathrotia et al. 2010). The MIS was assessed

prior to the study and after the study by the same assessor

(Kalantar-Zadeh et al. 2001).

Biochemical measurements

Urea, creatinine, haemoglobin, potassium, sodium, calcium,

phosphorus, total protein, total cholesterol, serum albumin and

total iron-binding capacity (TIBC) and C-reactive protein (as a

marker of inflammation) were measured in the fasting state at

baseline, and at the 1st, 2nd and 3rd month using standard

diagnostic methods.

STATISTICAL ANALYSIS

Results of the anthropometric measures, biochemical measures

and dietary intake were expressed as means � standard

deviations. Student’s t-test was performed at significant

difference of P � 0.01 for biochemical and dietary intake

variables and MIS. Correlations at significance level of P � 0.01

were also conducted between certain dietary intake data and

biochemical parameters. All the analyses were performed using

SPSS version 11.5.

RESULTSNUTRIENT COMPOSITION AND IN VITRO DIGESTIBILITY

OF ‘NUTRENE’ AND COOKIES

The nutrient composition and in vitro digestibility of proteins of

the supplements is given in Table 2. The fat content of cookies

prepared from ‘NUTRENE’ was higher (25%) compared with

that of ‘NUTRENE’ (1.43%). The total iron content of the cookies

was 3.1%, of which 1.30 mgwas bio-accessible. IVPD increased

from 40% in ‘NUTRENE’ to 73% in ‘NUTRENE’ cookies showing

that baking/heat treatment had a positive effect on protein

digestibility.

ANTHROPOMETRIC MEASURES

Fifteen subjects were selected for the three-month intervention

study and 13 completed the three months of evaluation. One

subject withdrew voluntarily from the study after four weeks

because she experienced muscle cramps (not thought to be

related to the dietary supplement). The other patient withdrew

after seven weeks because he had a hip fracture and was bed-

ridden. Both patients demonstrated a significant increase

in weight during their time in the study. ‘NUTRENE’


EFFECT OF NUTRITIONAL INTERVENTION ONMALNUTRITION INDICATORS IN PATIENTS ON

HAEMODIALYSIS

supplementation provided the subjects with 590 kcals, 10.4 g

protein, 15.7 g fat, 34 mg sodium, 220 mg potassium, 68 mg

calcium, 162 mg phosphorus and 3.2 mg iron on a daily basis

for three months along with their diet.

Table 3 shows the changes in anthropometric measures in the

patients during the study period. A significant increase was

noticed (P � 0.01) in all the measures (weight, MUAC,

MUAMC, waist and hip measurements) in all subjects. TSF

increased significantly (P � 0.01) but only in males. According

to Asia pacific standards BMI < 18.4 is categorised as being

underweight and �18.5–22.9 is considered normal. At

baseline, all males were underweight but at the end of the

study period they reached the normal levels of BMI (18.5 � 2.2).

Even though the females were in the normal range of BMI

at the beginning of intervention, the BMI increased signi-

ficantly (P � 0.01) from 20.4 � 4.6 to 22.4 � 3.6 at the

end of the study. Significant increases in MUAC, MUAMC

and waist measurements were observed post-supplemen-

tation; however, the increments did not reach the standard

levels.

BIOCHEMICAL PARAMETERS

Biochemical parameters are shown in Table 4. Haemoglobin

levels significantly increased (P � 0.01) from 8.2 g/dl (Day 0) to

8.4 g/dl at the end of the study, although this is still considered

low when compared with reference ranges.

Pre-dialysis blood urea nitrogen (BUN) increased significantly

(P � 0.01) from 107 to 129.5 mg/dl by the end of the study. It is

also interesting to note that urea levels significantly correlated

with MUAMC of subjects (r ¼ 0.573, P ¼ 0.04). Similarly, the

serum creatinine levels also increased significantly (P � 0.01)

from 8.7 to 9.8 mg/dl after the study.

The albumin levels increased significantly (P � 0.01) from

38 � 4.0 to 40 � 9.0 g/l at the end of the study.

Post-intervention, the TIBC levels increased significantly

(P � 0.01) in all subjects from 243.6 to 248.5 g/dl.

The increase in food intake affected the serum levels of minerals.

Mean serum potassium levels were at the high normal range

after three months of intervention. Significant increases were

observed inmean serum sodium, calcium and phosphorus levels

(P � 0.01) which were within normal ranges.

The serum total cholesterol increased significantly (P � 0.01)

during the intervention period but was within the normal range.

Anthropometric measures

0 months 3 months 0 months 3 months

Male Female

BMI 17.8 � 2.2 18.5 � 2.2 20.4 � 4.6 22.4 � 3.6Dry weight (kg) 50 � 9.2 52 � 9.2 54.9 � 13.2 56 � 13.0MUAC (cm) 21.9 � 2.6 23 � 1.73 23.8 � 1.43 25.3 � 1.9MUAMC 20.8 � 2.6 21.6 � 1.7 21.3 � 3.3 22.2 � 1.0TSF (cm) 3.3 � 0.8 3.8 � 1.0 10 � 6.4† 10.5 � 3.6Waist (cm) 74 � 11.6 76.4 � 10.9 75.7 � 14.3 77.7 � 13.9Hip (cm) 81.3 � 8.5 83.9 � 8.7 83.7 � 13.7 88.8 � 13.1

Table 3: Comparison of anthropometric measures and BMI—pre- and post-intervention.

0, pre-intervention; 3, post-intervention.Standards: MUAC (cm)—male: 29.3, female: 28.5; TSF (mm)—male: 12.5, female: 16.5; MUAMC—male: 25.3, female: 23.2; Waist (cm)—male: 90,female: 80.†No significant difference of P � 0.01 between 0 and 3.

Nutrient components NUTRENENUTRENEcookies

Moisture (g) 6.23 � 0.28 4.2 � 0.3Ash (g) 1.51 � 0.10 1.47 � 0.05Fat (g) 1.43 � 0.36 25 � 0.36Protein (g) 10.4 � 0.60 9 � 0.3Sodium (mg) 55 10.5Potassium (mg) 350 75Calcium (mg) 129 6.5Phosphorus (mg) 230 � 0.2 78 � 0.5Iron (mg) 2.65 � 0.02 3.10 � 0.02Copper (mg) 0.37 —Manganese (mg) 1.63 —Zinc (mg) 1.05 0.03In vitro protein bioaccessibility (%) 40 73In vitro iron bioaccessibility (mg) NA 1.30 � 0.02

Table 2: Nutrient composition of the supplements.a

aCalculated on the basis of 100 g dry components.NA, not analysed.


Roy et al.

Triglycerides tended to increase in the subjects throughout the

study but well within the normal range (<150 mg/dl).

The baseline mean CRP levels were high (0.4 mg/dl) which

significantly declined (P � 0.01) to 0.3 mg/dl at the end of the

study.

DIETARY INTAKE

Nutrient intake was calculated using 24-hour food recall before

and after supplementation (Table 5). Pre-intervention, the daily

energy intake (DEI) ofmales and femaleswas 16.0 � 3.98 kcals/

kg/day which is very low when compared with the recom-

mended DEI of 35 kcals/kg/day. All the subjects consumed

<20 kcals/kg/day. Similarly, the daily protein intake (DPI) before

supplementation was 0.39 � 0.11 g/kg/day in males and

slightly higher (0.41 � 0.22 g/kg/day) in females. The energy

intake increased significantly (P � 0.01) to 24 � 3.81 kcals/kg/

day in males and 27 � 8.8 kcals/kg/day in females after three

months of supplementation. A similar increment was also

observed in case of DPI after supplementation. Supplementa-

tion resulted in significant increases (P � 0.01) in DPI

(0.56 � 0.10 g/kg/day in males and 0.55 � 0.22 g/kg/day in

females).

The increment in TIBC levels had positively correlated

to increased iron consumption (r ¼ 0.485, P � 0.01). Haemo-

globin levels also correlated with iron intake (post-intervention)

though it was not significant (r ¼ 0.260, P � 0.01).

On average, the MIS scores decreased from 9 to 5.3 after the

study. At baseline, 12 patients were found to be classified as

mild-moderately malnourished (score 7–21) and 1 as normal

Nutrients

Intake

Recommended nutritional intake

Pre-intervention Post-intervention

M F M F

Energy* (kcals/d) 16 � 3.98 16 � 8.4 24 � 3.81 27 � 8.80 35 < 60 years30–35 � 60 years

Protein* (g/d) 0.39 � 0.10 0.41 � 0.22 0.56 � 0.10 0.55 � 0.21 1.2Sodium* (mg/d) 106 � 52 92 � 46 137 � 52 122 � 46 2,000Potassium* (mg/d) 578 � 282 505 � 307 732 � 283 657 � 308 2,000–3,000Calcium* (mg/d) 292 � 172 284 � 155 356 � 174 350 � 150 �2,000 From diet and medsPhosphorus* (mg/d) 589 � 292 599 � 329 689 � 296 677 � 323 800–1,000Iron (mg/d) 4.27 � 2.2 3.5 � 2.1 9.55 � 2.9 5.25 � 0.95 —

Table 5: Comparison of nutrient consumption—pre-and post-intervention.

Source: NKF (2001).*Significant difference of P � 0.01 when pre-intervention values compared against post-intervention.

Biochemical parameters 0 (pre) 1st month 2nd month 3rd month (post)

Haemoglobin (g/dl)† 8.2 � 1.2 8.4 � 0.9 8.4 � 0.9 8.4 � 1.09BUN (mg/dl)† 107 � 18.8 112 � 36.6 125.3 � 35.9 129.5 � 26.7Creatinine (mg/dl)† 8.7 � 2.7 9.5 � 2.6 9.9 � 3.1 9.8 � 2.5Total protein (g/dl)† 6.0 � 0.5 6.1 � 0.4 6.3 � 0.8 6.4 � 0.5Albumin (g/dl)† 3.8 � 0.4 3.9 � 0.3 3.8 � 0.3 4.0 � 0.9TIBC (mg/dl)†

Male 243.6 � 51 221 � 35.9 232 � 53.0 248.5 � 53.5Female 223 � 13.4 227 � 12.4 226 � 12.24 236 � 23.5

Triglycerides (mg/dl)† 89.1 � 16.2 151 � 55.0 108 � 29 95.4 � 46Total cholesterol (mg/dl)† 137.6 � 31.3 145.7 � 37.5 140.5 � 35.7 144.2 � 31.0Sodium (mequiv./l)† 138.3 � 2.3 138 � 3.3 138 � 2.8 138.9 � 2.7Potassium (mequiv./l)† 5.4 � 1.3 5.6 � 0.9 5.5 � 0.86 5.6 � 1.3Calcium (mg/dl)† 7.8 � 0.5 9.1 � 0.9 9.4 � 0.9 9.7 � 0.6Phosphorus (mg/dl)† 4.4 � 1.7 4.7b � 1.44 4.7 � 1.28 4.5 � 1.28HsCRP (mg/dl)† 0.4 � 0.48 0.53 � 0.37 0.48 � 0.38 0.3 � 1.03

Table 4: Comparison of biochemical parameters—pre-and post-intervention.†Significant difference of P � 0.01 when 3rd month values compared against initial values (0).



HAEMODIALYSIS

(score 0–6). By the end of intervention, three patients scored

between 7 and 21 (mild-moderately malnourished) and 10

patients shifted to the normal category of MIS. None of the

subjects scored above 22 which is the severely under-malnour-

ished classification.

DISCUSSIONThis is a first prospective nutrition intervention study from

India which has focused on a comprehensive evaluation of

biochemical, dietary and MIS variables in patients on HD.

Although, other studies have reported on various parameters

such as subjective global assessment and anthropometric

measurements, associations between dietary intakes, physical

status and biochemical measures in HD subjects are not

addressed (Desbrow et al. 2005; Tapiawala et al. 2006;

Janardhan et al. 2011).

‘NUTRENE’ was used to prepare an energy dense product

such as cookies. Pomegranate leaves (PM) are rich sources

of iron with a high antioxidant capacity when compared to

a commercial antioxidant (butylated hydroxyl toluene). In

addition, PM was stable as an antioxidant at high temperatures

thereby providing scope to be added in a baked product (Roy

& Urooj 2011). Therefore, cookies prepared from ‘NUTRENE’

were enriched with PM at 3% level. Another study revealed

the amount of b-carotene in Daucus carota and its stability

as an antioxidant during various processing and storage

conditions (Devi & Urooj 2006), which provides basis for

fortification.

Protein digestibility is essentially a measure of the susceptibility

of protein to proteolysis. A protein with high digestibility is

potentially of better nutritional value than one with low

digestibility because it providesmore amino acids for absorption

on proteolysis (Duodu et al. 2003). The improved IVPD of

cookies may be attributed to the fact that heat treatment causes

protein denaturation and/or decreases the resistance of protein

to enzyme attack (Sathe et al. 1982). As HD patients experience

difficulties in consumption due to anorexia and other factors,

‘NUTRENE’ was found to be well tolerated especially in terms of

its bulk and sensory characteristics.

In the present study, there were significant improvements in all

the anthropometric variables assessed. Such observations were

also reported by other researchers (Dare et al. 1997; Kalantar-

Zadeh et al. 2001). Patients on HD have a higher amount of iron

loss, due to blood loss during the HD process, oozing of blood

from the gastrointestinal tract and venepuncture leading to

anaemia (Eschbach et al. 1989). Thus, adequate available iron

stores cannot always bemaintainedwith dietary iron intake. This

may be the reason why haemoglobin (Hb) did not reach normal

levels, despite increments in Hb levels post-supplementation.

It is well known that a low pre-dialysis BUN level is associated

with a much greater risk of death than a BUN level between

90 and 110 mg/dl (Lowrie & Lew 1990). There were significant

increments in both BUN and serum creatinine from baseline

levels at the end of the study. Increases in food intake especially

proteins are associated with increases in BUN and serum

creatinine in patients undergoing HD (Lowrie & Lew 1990).

According to Lowrie and Lew’s study (1990), mortality increased

progressively as serum albumin levels decreased. They also

reported that the risk of death increased by greater than twofold

for HD patients with serum albumin levels of 35–40 g/l when

compared with patients who have serum levels of 40–45 g/l.

Another study by Kaminski et al. (1991) also showed an

association between albumin levels (40 g/l) and increased

mortality. The authors suggested that nutrition support should

be considered for patients with albumin levels <35 g/l. In the

present study, ‘NUTRENE’ supplementation significantly in-

creased the albumin levels. This can be associated with the

observed decrease in Hs (high-sensitivity) CRP levels (Kaysen

2001). Available evidence suggests that CRP is a precise and

objective index of inflammatory activity and that it accurately

reflects the generation of proinflammatory cytokines which are

associated with increased mortality in patients undergoing

dialysis (Bologa et al. 1998; Kimmel et al. 1998). Increased

proinflammatory cytokine levels predict hypoalbuminemia

(Kaysen 2001). Therefore, the reductions in HsCRP might be

attributed to the effect of supplementation. Post-supplementa-

tion, HsCRP results tended to remain in the high normal range,

suggesting the presence of inflammation in the subjects.

It was interesting to note that although the subjects were

considered malnourished as per their physical indices (such as

BMI), their TIBC levels pre-intervention, were in the normal

ranges. It is well known that serum TIBC levels are influenced by

inflammation and iron stores as well as protein–energy

nutritional status (K/DOQI, 2002). The increase in serum

cholesterol and triglycerides may be due to the increase in

dietary fat and energy (especially cookies) consumption during

the study. Lowrie and Lew (1990) found low cholesterol


Roy et al.

concentration (<150 mg/dl) to be associated with high

mortality risk in HD patients, whereas increased total serum

cholesterol levels seems to have little effect on mortality.

Therefore, increases in serum cholesterol and triglycerides were

desirable in this study.

The significant increases in DEI and DPI were due to the

increase in the quantity of the routine food/meals consumed

by the subject as observed by the 24-hour food recall.

The reasons for this change as mentioned by the subjects

were that they felt energetic, had greater appetite and had

a change in their usual unpalatable diet once the supple-

mentation commenced. Similarly, intake of calcium, phospho-

rus, iron, sodium and potassium increased significantly

during the study which can also be attributed to the

ingestion of the supplement. Increase in iron intake could be

attributed to the consumption of the supplement which was

fortified with a natural iron source (pomegranate leaves).

Improvements in weight, dietary intake, GI symptoms,

functional capacity and increase in levels of BMI, albumin

and TIBC were the reasons for a lower MIS in the subjects post-

intervention.

Though the sample size of the present study was small, it was

able to show the beneficial effect of the usage of a disease

specific supplement which was well tolerated by patients. It

should also be noted that despite supplementation, the

nutritional requirements for patients on HD were not met. It

is recommended that a long-term nutrient supplementation is

required along with nutrition counselling/support to improve

nutrient intake and reverse malnutrition.

IMPLICATIONS FOR PRACTICEPatients undergoing HD are at risk ofmalnutrition due to a variety

of reasons such as physical disabilities, a reduced and unpalatable

diet, financial constraints, anorexia and other comorbidities. At

the onset of the disease, people who are malnourished are

generally considered to be at higher risk of morbidity and

mortality. Therefore, nutritional management has to be given

priority. For Indian patients on HD this is particularly important,

considering their economic background, their unawareness

about nutritional requirements and the availability of various

supplements that cater for people with kidney disease.

CONCLUSIONThis prospective intervention study has demonstrated the

potential use of renal specific food formulations in improving

several clinical parameters and the nutritional status of people

on HD. There is a need for further clinical trials, especially in

India, to identify the effectiveness of such formulations to

reduce the burden of malnutrition in those with ESRD.

ACKNOWLEDGEMENTSThe authors thank the University Grants Commission, New

Delhi, India for the financial assistance provided to undertake

the study.

CONFLICT OF INTERESTNo conflict of interest has been declared by the authors.

AUTHOR CONTRIBUTIONSLGR: Principal Project Leader. Participated in design and coordi-

nation, undertook interviews analysis and interpretation of the

obtained data.

MSS: Participated in design and coordination. Provided

important intellectual content to prepare the article.

AU: Participated in design and coordination, helped to draft

manuscript, read and approved the final manuscript.

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EFFECT OF NUTRITIONAL INTERVENTION ON MALNUTRITION INDICATORS IN PATIENTS ON HAEMODIALYSIS