HF: Protein Needs (2008)
Citation:
Study Design:
Class:
- Click here for explanation of classification scheme.
Quality Rating:
Research Purpose:
To investigate the adequacy of nutrition and calculated energy availability for the physical activity of non-obese patents with stable chronic heart failure (HF).
Inclusion Criteria:
- Heart failure patients: Body mass index (BMI) under 25, stable New York Heart Association Class II to III chronic heart failure
- Controls: Healthy, sedentary, matched.
Exclusion Criteria:
All others.
Description of Study Protocol:
- Recruitment:Not described
- Design: Cross-sectional
- Blinding used: None
- Statistical analysis: Not described.
Data Collection Summary:
Timing of Measurements
- Food diaries were kept for seven days
- 24-hour urine was collected for three consecutive days
- Resting energy expenditure (REE) was measured 12 to 14 hours after overnight fasting
- Venous blood was drawn at 8:00 a.m. for cortisol and insulin values
- All were performed once.
Dependent Variables
- Variable One
- REE was measured 12 to 14 hours after overnight fasting
- Oxygen consumption and carbon dioxide production were measured at one-minute intervals and means of 60-minute measurements were used to calculate REE
- This calculation (kcal per day) was adjusted for body surface (kcal per m2)
- From REE the daily energy expenditure (TEE) was calculated
- The calorie balance was calculated as the number of kilocalories introduced in the diet per day, less the TEE.
- Variable Two
- Nitrogen balance was calculated as nitrogen intake with food, less total nitrogen loss (g per 24 hours), which was equal to urea nitrogen excretion plus two g (loss of nitrogen from feces and skin)
- 24-hour urines were collected for three consecutive days.
- Venous blood was drawn at 8:00 a.m. for cortisol and insulin values.
Independent Variables
Presence or absence of heart failure.
Description of Actual Data Sample:
- Initial N: 55 HF (unknown gender) and 49 controls (unknown gender)
- Attrition (final N): Same
- Age: Not stated
- Ethnicity: Venous blood was drawn at 8:00 a.m. for cortisol and insulin values
- Anthropometrics: Controls were matched (no further description)
- Location: Italy.
Summary of Results:
Variables |
HF Group |
Control Group |
Statistical Significance of Group Difference |
REE (kcal/m2) |
870±13 |
777±15 |
P≤0.01 |
Calorie Intake (kcal/kg) |
28.3±0.8 |
29.5±1.2 |
NS |
TEE (kcal/day) |
1,950±43 |
1,700±53 |
P≤0.01 |
Calorie Balance |
-186±40 |
104±35 |
P≤0.01 |
Nitrogen Balance (g/day) |
-1.7±0.4 |
2.2±0.5 |
P≤0.01 |
Nitrogen Intake |
11.8±0.2 |
11.8±0.6 |
NS |
Cortisol-Insulin Ratio |
65.0±5.1 |
32±1.7 |
P≤0.01 |
Author Conclusion:
- Non-obese patients with chronic HF did not have an adequate intake of calories and protein to support their metabolic needs for daily life activities
- These patients have an important hypermetabolic state, with consequent protein breakdown.
Funding Source:
Reviewer Comments:
The authors did not describe the formula used to determine TEE from the REE.
Quality Criteria Checklist: Primary Research
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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? | N/A | |
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? | No | |
2.2. | Were criteria applied equally to all study groups? | Yes | |
2.3. | Were health, demographics, and other characteristics of subjects described? | No | |
2.4. | Were the subjects/patients a representative sample of the relevant population? | ??? | |
3. | Were study groups comparable? | ??? | |
3.1. | Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT) | No | |
3.2. | Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline? | ??? | |
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.) | ??? | |
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? | N/A | |
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? | N/A | |
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? | No | |
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.) | No | |
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? | 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? | ??? | |
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? | 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? | ??? | |
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? | ??? | |
8.1. | Were statistical analyses adequately described and the results reported appropriately? | No | |
8.2. | Were correct statistical tests used and assumptions of test not violated? | ??? | |
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? | No | |
9.1. | Is there a discussion of findings? | No | |
9.2. | Are biases and study limitations identified and discussed? | No | |
10. | Is bias due to study's funding or sponsorship unlikely? | ??? | |
10.1. | Were sources of funding and investigators' affiliations described? | No | |
10.2. | Was the study free from apparent conflict of interest? | ??? | |