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 | |