H/A: Caloric Needs (2007)

Citation:
 
Study Design:
Class:
- Click here for explanation of classification scheme.
Quality Rating:
Research Purpose:

To assess the influence of malabsorption on nutritional status and energy expenditure in patients at different stages of HIV infection.

Inclusion Criteria:
None given.
Exclusion Criteria:
  • Patients with known non-AIDS-related malabsorption disease
  • With malignant or Kaposi's sarcoma
  • Treatment with drugs that could modify REE such as corticoids.
Description of Study Protocol:

Recruitment

HIV-seropositive patients were recruited consecutively from the HIV outpatient department.

Design

Case-control study. 

Blinding Used

Implied for measures.

Statistical Analysis

  • Differences between groups were analyzed using the Mann-Whitney non-parametric test
  • Paired data were analyzed by the Wilcoxon non-parametric test
  • Simple correlations were determined using Spearman's correlation coefficient
  • As REE was significantly related with TBIA-FFM (R=0.80, P<0.001), the unexplained residual of the REE in each individual was calculated by the general linear model procedure using the FFM as covariant. The adjusted REE (REEa) for each individual was calculated by adding the individual residual REE to the mean REE of the whole group.
Data Collection Summary:

Timing of Measurements

  • From November 1995 to December 1996
  • Patients were hospitalized for three days for the conduct of the analyses.

Dependent Variables

  • Weight
    • Weight and height determined on admission
    • Weight change in previous one and three months was recorded
    • IBW was established by use of Spanish population reference data
    • Actual body weight expressed as a percentage of IBW
    • BMI was calculated.
  • Body composition: Tetrapolar bioelectrical impedance
  • Energy expenditure
    • Open-circuit indirect calorimetry
    • 24-hour urinary nitrogen excretion was measured using the Kjeldahl technique
    • REEm was calculated from VO2, VCO2 and urinary nitrogen excretion using the equation of Weir
    • Estimated resting energy expenditure was calculated from Harris and Benedict equations.
  • Absorption studies
    • Standard D-xylose test was used to evaluate sugar absorption
    • Fat absorption was determined by the 14C triolein breath test
    • HIV-infected individuals were reclassified into two groups with respect to the presence or absence of malabsorption.

Independent Variables

  •  HIV-positive patients divided into three groups
    • Asymptomatic HIV patients who had not had an AIDS-defining illness
    • AIDS patients without secondary infection
    • AIDS patients, who at the time of the study, had symptoms or signs of active secondary infection.
  • AIDS patients also sub-divided into no-malasorption and malabsorption categories
  • Clinically healthy volunteers served as controls.

Control Variables

 None stated; implied some of the dependent variables serve as controls.

Description of Actual Data Sample:
  • Initial N
    • 50 (36 men and 14 women) HIV-seropositive patients
    • 19 (14 men and five women) clinically healthy controls from hospital and laboratory staff with low risk for HIV infection
    • For fat malabsorption test, another control group of 10 healthy subjects.
  • Attrition (final N): Same as initial
  • Age: HIV-positive 34.8 (range 25 to 65)
  • Ethnicity: Not given (implied Spanish)
  • Other relevant demographics: Not given
  • Anthropometrics: See Table One in Results; disease and medication information
    • Diagnosis of AIDS was established according to CDC
    • Patients were receiving antiretroviral treatment, according to standard protocols that included combination of the two nucleoside reverse transcriptase inhibitors [zidovudine plus didanosine (DDI) or zidovudine plus zalcitabine (DDC)]
    • Twenty patients were receiving oral fluconazol for antifungal prophylaxis and oral co-trimoxazole or pentamidine aerosol for P. carinii prophylaxis.
  • Location: Patients were recruited from the HIV outpatient department at the Hospital Sant Joan de Reus.
Summary of Results:

 Table One: Biometric Characteristics of the Study Population

Variables

Group One (N=17)

Group Two (N=16)

Group Three (N=17)

Patients (N=50) Controls (N=19)

Male:Female

13:4

10:6

13:4

36:14 14:5

Age (years)

34.8 (9.1) 

35.2 (9.7) 

34.2 (6.9) 

34.8 (8.5) 33.2 (4.2)
Weight (kg) 58.6 (10.6)**# 63.2 (12.0)*# 51.8 (7.2)*** 57.7 (10.9)*** 72.0 (9.2)
BMI (kg/m2) 21.5 (3.5)*# 22.5 (3.7)### 18.1 (2.1)*** 20.7 (3.6)*** 24.4 (2.4)
Percentage Ideal Body Weight 84.9 (13.6)**#  91.1 (15.9)*###  72.4 (9.1)***  82.6 (15.1)***  98.2 (8.2) 
Weight Loss Previous Month (kg)  0.7 (0.9)***###  1.7 (2.6)***##  3.6 (2.4)***  2.1 (2.9)*** 
Weight Loss Previous Three Months (kg)  1.1 (0.9)***###  2.6 (2.7)***##  5.2 (3.6)***  2.9 (3.1)*** 
Serum Albumin (g/L)  38.1 (3.7)***###$  34.6 (5.1)***#  29.3 (6.0)***  34.1 (6.2)***  44.2 (1.5) 
CD4 Count (Cells x106/L)  500.9 (206.9)***###$$  86.7 (48.8)***  119.1 (155.2)***  238.6 (242.8)***  1,012.11 (367.7) 

* P<0.05
** P<0.005
*** P<0.001, compared with controls
# P<0.05
## P<0.005
### P<0.001, compared with Group Three
$ P<0.05
$$ P<0.001, compared with Group Two
[Note: Height not different among groups.]

Table Two: Summary of the Absorption Tests

Variables

Group One (N=17)

Group Two (N=16)

Group Three (N=17)

Controls (N=19)

Xylose 5-h Urine (g)

5.12 (3.12)**

3.68 (2.39)**

2.97 (2.12)**

10.01 (3.27)

Xylose 20-h Serum (mmol/L)

2.74 (0.92) 

2.82 (1.41) 

2.13 (1.89)* 

2.98 (0.36)
Peak (14CO2) Production (Percentage) 7.29 (3.44)**## 5.50 (4.16)**# 3.06 (2.19)** 14.00 (4.09)
Total (14CO2) Production (Percentage) 5.00 (1.94)**# 4.80 (2.27)**# 2.99 (1.73)** 10.64 (3.71)

* P<0.05
** P<0.001, compared with controls
# P<0.05
## P<0.001, compared with Group Three.

Table Three: Body Composition and Resting Energy Expenditure (REE) at Different Stages of HIV Infection

Variables

Group One (N=17)

Group Two (N=16)

Group Three (N=17)

Controls (N=19)

Fat-Free Mass (kg)

45.3 (8.4)**

46.9 (8.3)

42.2 (7.1)**

54.8 (8.8)

Fat Mass (kg)

13.2 (5.3)*

16.3 (6.7)#

9.6 (4.9)***

17.2 (4.1)
Proportion Body Fat (Percentage) 22.2 (7.4) 25.2 (7.4) 18.5 (8.9) 24.01 (5.7)
REE Measured (kJ/Day) 6,291.7 (963.9) 6,294.0 (793.2) 5,861.6 (932.1)** 6,802.1 (862.7)
REE Adjusted (kJ/Day) 6,466.8 (704.3) 6,344.3 (496.5) 6,289.2 (589.9) 6,220.4 (478.2)
REE Estimated (kJ/Day) 6,017.7 (774.5) 6,217.3 (807.3) 5,683.9 (541.2) 6,862.1 (792.7)

* P<0.05
** P<0.005
*** P<0.001, compared with controls
# P<0.05, compared with Group Three.

Table Four: Nutritional Status, Body Composition and Resting Energy Expenditure (REE) with Respect to Presence or Absence of Malabsorption

Variables

Malabsorption (N=34)

No Malabsorption (N=16)

Controls (N=19)

Male:Female

27:7

9:7

14:5

Age (Years)

33.8 (7.3)

36.7 (10.5) 

33.2 (4.1)
Weight (kg) 56.0 (10.0)*** 61.4 (12.4)* 72.0 (9.2)
Percentage Ideal Body Weight 78.7 (11.9)#*** 90.0 (17.9)  98.1 (8.2) 
BMI (kg/m2) 19.8 (2.9)#*** 22.7 (4.2) 24.4 (2.3)
Weight Loss Previous Month (kg)  2.4 (2.6)***  1.7 (1.5)*** 
Weight Loss Previous 3 Months (kg)  3.3 (2.7)***##  2.1 (3.7)*** 
CD4 Count (Cells x106/L)  188.1 (211.1)***  345.8 (276.4)***  1,012.1 (367.7) 
Serum Albumin (g/L)  32.9 (5.7)  36.3 (6.6)  44.2 (1.5) 
Fat-Free Mass (kg) 44.4 (7.6)**  45.6 (9.0)*  54.8 (8.8) 
Proportion Body (Percentage) 20.3 (8.0)  25.1 (8.5)  24.01 (5.7) 
REE Measured (kJ/Day) 6,006.3 (846.5)*  6,443.4 (985.5)  6,802.1 (862.7) 
REE Adjusted (kJ/day) 6,256.3 (552.9)  6,601.9 (637.5)  6,220.4 (478.2) 
REE Estimated (kJ/Day) 5,935.8 (657.9)  6,036.5 (897.2)  6,862.1 (792.7) 

*P<0.05
** P<0.005
*** P<0.001, compared with controls
# P<0.05
## P<0.005, compared with non-malabsorptive.

Other Findings

  • In the overall patient group, a significant correlation between CD4 counts and peak output (R=0.49, P<0.001) as well as total output of (14CO2) (R=0.36, P<0.01) was observed
  • With respect to stage of HIV infection, malabsorption was found in nine patients (53%) of Group One, 11 patients (69%) of Group Two and 14 patients (82%) of Group Three
  • Significant negative correlation between weight loss during the previous three months and five-hour xylose excretion (R=-0.30, P<0.05) as well as peak triolein output (R=-0.38, P<0.01) in the overall patient population
  • Negative correlation between weight loss during the previous one month and peak output (R=-0.30, P<0.05) as well as total output of triolein (R=-0.29, P<0.05)
  • 34 (68%) patients evidenced malabsorption; 27 (54%), with respect to sugar malabsorption and 21 (42%) to fat; 14 (28%) patients had sugar and fat malabsorption
  • Significant correlation beteen sugar and absorption was observed (R=0.41, P<0.05)
  • Half of individuals with malabsorption reported anorexia; five patients had diarrhea during the course of the study but stool cultures were negative
  • When REE was analyzed at different stages of the disease and, with the presence or absence of malabsorption taken into account, REEm was lower in patients with opportunistic infections and malabsorption, although the differences were not statistically significant.
Author Conclusion:
  • Findings demonstrate that hypermetabolism is not a constant phenomenon in HIV infection
  • Factors such as malabsorption and decrease in caloric intake that are often secondary, are probably of greater importance in explaining the observed weight loss
  • Malabsorption was a frequent phenomenon in HIV infection and was present in early stages of the disease, as well as in asymptomatic patients
  • Malabsorption and secondary anorexia were the aspects responsible for the weight los observed in the HIV-infected patients, particularly in those with associated opportunistic infection
  • The high incidence of malabsorption and its significant correlation with weight loss suggests that this parameter needs to be taken into account in clinical monitoring of AIDS patients.
Funding Source:
Reviewer Comments:
Quality Criteria Checklist: Primary Research
Relevance Questions
  1. Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies) Yes
  2. Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about? Yes
  3. Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice? Yes
  4. Is the intervention or procedure feasible? (NA for some epidemiological studies) Yes
 
Validity Questions
1. Was the research question clearly stated? Yes
  1.1. Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified? Yes
  1.2. Was (were) the outcome(s) [dependent variable(s)] clearly indicated? Yes
  1.3. Were the target population and setting specified? Yes
2. Was the selection of study subjects/patients free from bias? Yes
  2.1. Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study? Yes
  2.2. Were criteria applied equally to all study groups? Yes
  2.3. Were health, demographics, and other characteristics of subjects described? Yes
  2.4. Were the subjects/patients a representative sample of the relevant population? ???
3. Were study groups comparable? Yes
  3.1. Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT) Yes
  3.2. Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline? Yes
  3.3. Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.) Yes
  3.4. If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis? N/A
  3.5. If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.) N/A
  3.6. If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")? N/A
4. Was method of handling withdrawals described? Yes
  4.1. Were follow-up methods described and the same for all groups? N/A
  4.2. Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.) N/A
  4.3. Were all enrolled subjects/patients (in the original sample) accounted for? Yes
  4.4. Were reasons for withdrawals similar across groups? N/A
  4.5. If diagnostic test, was decision to perform reference test not dependent on results of test under study? N/A
5. Was blinding used to prevent introduction of bias? Yes
  5.1. In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate? N/A
  5.2. Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.) Yes
  5.3. In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded? N/A
  5.4. In case control study, was case definition explicit and case ascertainment not influenced by exposure status? Yes
  5.5. In diagnostic study, were test results blinded to patient history and other test results? N/A
6. Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described? Yes
  6.1. In RCT or other intervention trial, were protocols described for all regimens studied? N/A
  6.2. In observational study, were interventions, study settings, and clinicians/provider described? Yes
  6.3. Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect? Yes
  6.4. Was the amount of exposure and, if relevant, subject/patient compliance measured? N/A
  6.5. Were co-interventions (e.g., ancillary treatments, other therapies) described? N/A
  6.6. Were extra or unplanned treatments described? N/A
  6.7. Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups? N/A
  6.8. In diagnostic study, were details of test administration and replication sufficient? N/A
7. Were outcomes clearly defined and the measurements valid and reliable? Yes
  7.1. Were primary and secondary endpoints described and relevant to the question? Yes
  7.2. Were nutrition measures appropriate to question and outcomes of concern? Yes
  7.3. Was the period of follow-up long enough for important outcome(s) to occur? N/A
  7.4. Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures? Yes
  7.5. Was the measurement of effect at an appropriate level of precision? Yes
  7.6. Were other factors accounted for (measured) that could affect outcomes? Yes
  7.7. Were the measurements conducted consistently across groups? Yes
8. Was the statistical analysis appropriate for the study design and type of outcome indicators? Yes
  8.1. Were statistical analyses adequately described and the results reported appropriately? Yes
  8.2. Were correct statistical tests used and assumptions of test not violated? Yes
  8.3. Were statistics reported with levels of significance and/or confidence intervals? Yes
  8.4. Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)? N/A
  8.5. Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)? N/A
  8.6. Was clinical significance as well as statistical significance reported? N/A
  8.7. If negative findings, was a power calculation reported to address type 2 error? N/A
9. Are conclusions supported by results with biases and limitations taken into consideration? Yes
  9.1. Is there a discussion of findings? Yes
  9.2. Are biases and study limitations identified and discussed? Yes
10. Is bias due to study's funding or sponsorship unlikely? Yes
  10.1. Were sources of funding and investigators' affiliations described? Yes
  10.2. Was the study free from apparent conflict of interest? Yes