EAL

H/A: Dietary Intake (2007)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To assess dietary intake and physical activity in a Canadian population sample of men with HIV and metabolic abnormalities and to compare the data with Canadian recommendations.

Inclusion Criteria:

HIV-infected men with at least one feature of the metabolic syndrome (high fasting plasma glucose, insulin resistance, dyslipidemia, central obesity or lipodystrophy)
Patients had to be on a stable drug regimen for at least eight weeks prior to study entry.

Exclusion Criteria:

Excluded if there was concomitant acute infection or malignancy.

Description of Study Protocol:

Recruitment: Between July 2004 and May 2007, 65 male patients with documented HIV infection were prospectively enrolled at the University Health Network, Toronto, Ontario, Canada.
Design: Cross-sectional analysis of a cohort
Blinding used: Not applicable
Intervention: Not applicable.

Statistical Analysis

Results are given as mean ± standard error of the mean (SEM) for patient characteristics, anthropometric data and physical activity
Frequencies are described as percentage of the study population
Reported energy intake was compared with estimated energy requirements using the Wilcoxon signed rank test
Mann-Whitney U-test was applied to compare normal weight and overweight or obese patients
Spearman correlations were calculated to examine associations between physical activity, nutrient intake and metabolic parameters.

Data Collection Summary:

Timing of Measurements

Results from seven-day food records and activity logs were compared to the Dietary Reference Intakes and recommendations of Canada's Physical Activity Guide to Healthy Active Living. Anthropometric measurements were also taken.
Repeated weight measurements over two to six months were available for 49 patients.

Dependent Variables

Anthropometric measurements: weight, height, BMI, waist and hip circumference, waist:hip ratio
Body composition measured through bioelectrical impedance analysis
Blood samples analyzed for fasting glucose, insulin, c-peptide, HbA1c, blood lipid profile, HOMA.

Independent Variables

Dietary intake measured using seven-day food records
Physical activity measured with seven-day activity logs.

Control Variables

Age
Race or ethnicity
Time since HIV diagnosis
Duration of antiretroviral treatment
Current medications
HIV viral load
CD4+ T-lymphocyte cell count.

Description of Actual Data Sample:

Initial N: 65 male patients
Attrition (final N): 65 men; physical activity logs available from 58 patients
Age: Mean, 47.0±0.9 years
Ethnicity: 81.5% white; 10.8% African-American; 7.7% Asian.

Other Relevant Demographics

89.2% of patients were on highly active antiretroviral therapy (HAART):

91.7% taking nucleotide or nucleoside reverse transcriptase inhibitors
55% taking protease inhibitors
48.3% taking non-nucleoside reverse transcriptase inhibitors.

Mean CD4 count, 487±33 cells per mm³.

Location

Canada.

Summary of Results:

Key Findings

32% of patients were normal weight, 52% of the subjects were overweight and 15% were obese
None of the patients were underweight
Energy intake (2,153±99kcal per day) was lower than the estimated requirement (2,854±62kcal per day, P<0.0001)
62% of patients reported energy intakes of less than 80% of estimated energy requirements
84.5% of the patients reached the recommended minimum of 60 minutes of mild or 30 minutes of moderate daily exercise
On average, the macronutrient distribution was within the acceptable range
Protein intake was largely adequate, whereas 41.5% of the patients consumed more than 35% of total energy from fat and for 29.2% intake of carbohydrates was less than the acceptable minimum
Intake was high for fat and cholesterol in 40% of patients
No patient reached the recommendation for fiber
Intake from diet alone was sub-optimal for most micronutrients
Prevalence was highest for low vitamin E (91% of patients) and magnesium (68%) intakeand high sodium intake (72%)
Between normal weight and overweight or obese patients, there was no statistically significant difference in physical activity, intake of energy, macro- and micronutrients or metabolic parameters.

Author Conclusion:

Our data suggest that male patients with HIV and features associated with the metabolic syndrome are in majority overweight or obese. Even though physical activity seems adequate, the patients follow a typical high-fat, low-fiber Western diet with sub-optimal intakes of many micronutrients. This could play a role in the development of their metabolic disorders and in HIV disease progression.
At the same time, excess intake of some nutrients seems to be an important issue in this population that needs to be addressed by health care providers.
The study therefore underlines the position of American Dietetic Association and Dietitians of Canada that nutrition evaluation and counseling should be an integral part of the care for HIV patients.

Funding Source:

Not-for-profit

Canadian Foundation for AIDS Research, German Research Foundation

Other non-profit:

Other:

The Ontario HIV Treatment Network

Reviewer Comments:

Only men studied
Measurements not made in all subjects
Authors note the following limitations:
- Low reported energy intakes compared to estimated requirements suggest under-reporting in the study population
- Results of this study may not be valid for patients with HIV in general, as the study group consisted mainly of white homosexual or bisexual men.

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)	N/A
	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)	N/A

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?		???
	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?	N/A
	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?	No
3.	Were study groups comparable?		N/A
	3.1.	Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT)	N/A
	3.2.	Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline?	N/A
	3.3.	Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.)	N/A
	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?	Yes
	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?	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?	N/A
	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?	N/A
	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?	N/A
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?	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