EAL

H/A: Dietary Intake (2007)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To compare the progression of clinical and nutritional indicators during nutritional supplementation with or without an enterotropic peptide-based formula enriched with n-3 fatty acids.

Inclusion Criteria:

Between 18 and 60 years of age
Confirmed HIV infection with or without AIDS-defining illness
Absence of chronic febrile illness
Absence of GI symptoms (diarrhea for more than 30 days or more than three times per day)
Adequate liver function and normal kidney function
Subjects of stable weight.

Exclusion Criteria:

Excluded if not included above.

Description of Study Protocol:

Recruitment

Methods not specified.

Design

Randomized clinical trial.

Intervention

One group received standard enteral formula and the other group received an enterotropic peptide-based enteral formula, three cans per day
In both groups, the enteral supplementation was recommended in conjunction with an RD under a dietary counseling program, based on standard nutrition principles.

Statistical Analysis

Distribution of variables analyzed with Kolmogorov-Smirnov test
Quantitative variables with normal distribution were analyzed with two-factor repeated-measures ANOVA including interaction terms
Non-parametric variables were analyzed with the Mann-Whitney U-test
Discrete variables were analyzed with the chi-square test, with Yates correction as necessary and Fisher's test
All patients were included on an intention-to-treat analysis.

Data Collection Summary:

Timing of Measurements

Measurements made at baseline and at three months.

Dependent Variables

GI symptoms
Basal blood sampling for blood chemistry, liver function tests, hematologic parameters and CD4 counts and HIV viral loads
Anthropometric status: Weight and BMI
Body composition determined through bipolar body electrical bioimpedance
Infections and hospitalizations.

Independent Variables

One group received standard enteral formula and the other group received an enterotropic peptide-based enteral formula, thee cans per day
Nutritional intake measured with 24-hour written food records.

Description of Actual Data Sample:

Initial N

91 patients screened for the study
23 did not meet inclusion criteria
74 patients were randomized
38 to standard formula (77.6% male)
36 to supplementation (78.6% male).

Attrition (final N): 74, all patients completed
Mean age

Standard formula: 38.9±8.8 years

Supplemented, 37.9±10 years.

Ethnicity: Not mentioned
Anthropometrics: There were no significant differences between groups at baseline.
Location: Spain.

Summary of Results:

	Standard; Baseline	Standard; Three Months	Supplemented; Baseline	Supplemented; Three Months
Weight (kg)	62.7±10.9	64.7±11.6, P<0.05	61.1±11.2	63±11.3, P<0.05
BMI	22.04±2.8	22.7±3, P<0.05	21±2.8	21.9±2.6, P<0.05
Fat-Free Mass (kg)	52.3±9.9	52.8±10	52.9±10.5	52.2±12.9
Fat Mass (kg)	10.2±4.6	11.7±4.9, P<0.05	8.6±3.8	9.3±3.6, P<0.05
Total Water (kg)	38.3±7.3	38.2±7.1	38.6±8	38.4±7.5
Tricipital Skinfold (mm)	17.9±4.3	20.2±4.8, P<0.05	18.02±4.7	19.5±4.5, P<0.05
Circumference Arm (cm)	26.7±2.9	27.1±2.7	26.9±3.7	27.2±3.2

Other Findings

Treatments with both supplements resulted in a significant and sustained increase in weight (3.2% in standard and 3.1% in supplemented). This increase was mostly due to fat mass (12.8% in standard and 7.5% in supplemented).
Total body water and fat-free mass remained unchanged
CD4 counts remained stable in the standard group, while a significant increase was detected in the supplemented group (576±403 vs. 642±394 cells per mm³, P<0.05)
After the three-month period, CD4 counts remained higher in the supplemented group
The supplemented group had fewer hospitalizations than the standard group, but no statistical differences were found.

Author Conclusion:

In conclusion, oral nutritional supplements for a three-month period were well tolerated and resulted in body weight gain in HIV-infected patients
Supplement enriched with peptides and n-3 fatty acids increases CD4 count.

Funding Source:

University/Hospital:

Universitario Rio Hortega, Cliniqueco University (Both Spain)

Reviewer Comments:

All patients completed the trial.

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?	Yes
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?	Yes
	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%.)	Yes
	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?	N/A
	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?	Yes
	6.2.	In observational study, were interventions, study settings, and clinicians/provider described?	N/A
	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?	Yes
	6.5.	Were co-interventions (e.g., ancillary treatments, other therapies) described?	Yes
	6.6.	Were extra or unplanned treatments described?	Yes
	6.7.	Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups?	Yes
	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?	Yes
	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)?	Yes
	8.5.	Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)?	Yes
	8.6.	Was clinical significance as well as statistical significance reported?	Yes
	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