EAL

AWM: Low Carbohydrate Diet (2006)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To compare a very-low-carbohydrate diet and a low-fat weight loss diet on inflammatory biomarkers in overweight men.

Inclusion Criteria:

Overweight but otherwise healthy men.

Exclusion Criteria:

None specifically mentioned.

Description of Study Protocol:

Recruitment

Subjects volunteered for study.

Design

Randomized Crossover Trial.

Blinding used (if applicable)

Not used.

Intervention (if applicable)

Subjects consumed a very-low-carbohydrate diet and a low-fat diet for 2 consecutive 6-week periods.

Statistical Analysis

One-way repeated measures ANOVA was used to evaluate changes over time for all variables. Significant main effects were analyzed further using Fisher least significant difference post-hoc test. Normalized inflammatory biomarkers analyzed with paired Student's t tests.

Data Collection Summary:

Timing of Measurements

Subjects consumed 2 weight loss diets for 2 consecutive 6-week periods. Fasting blood samples taken at baseline and after each diet.

Dependent Variables

Blood samples measured for high-sensitivity IL-6, high-sensitivity TNF-alpha, soluble ICAM-1, soluble P-selectin and high-sensitivity CRP, and determined using ELISA

Independent Variables

Very-low-carbohydrate (<10% kcals from carbohydrate, 30% protein, 60% fat) or low-fat diet (20% protein, 25% fat and 55% carbohydrate), both designed to be hypoenergetic (-2.1 MJ/day). Energy levels based on nearest 837 kJ increment based on REE obtained with indirect calorimetry. Dietary compliance checked for urinary reagent strips when in ketosis during very-low-carbohydrate diet. Analysis performed on 7 days of diet records at baseline and 21 days during the experimental periods.

Control Variables

Description of Actual Data Sample:

Initial N: 15 men

Attrition (final N): 15 men

Age: 33.2 +/- 11.3 years

Ethnicity: Not mentioned.

Other relevant demographics: Body mass: 109.1 +/- 17.8 kg, body fat: 34.9 +/- 5.2%, BMI 34.3 +/- 5.6

Anthropometrics:

Location: University of Connecticut

Summary of Results:

	Baseline	Low-carb	Low-fat
Energy MJ	10.86 +/- 2.47	7.77 +/- 1.81	6.54 +/- 1.19
Protein %	16 +/- 2	28 +/- 5	20 +/- 4
Carbs %	47 +/- 5	8 +/- 3	56 +/- 7
Fat %	35 +/- 4	63 +/- 4	23 +/- 7

Other Findings

Both the very-low carbohydrate diet and low-fat diet resulted in significant decreases in body mass (-6.5 +/- 3.0 kg, P < 0.01, and -3.7 +/- 3.3 kg, P < 0.01, respectively). There was no order effect as to which diet the subject was initially randomized to.

The low carbohydrate diet was significantly different from the low-fat diet for energy, protein, carbohydrate, total fat, saturated fat, polyunsaturated fat and cholesterol (P < 0.05).

Both the low-fat and the very-low carbohydrate diets resulted in significant decreases in absolute concentrations of high-sensitivity tumor necrosis factor-alpha, high-sensitivity interleukin-6, high-sensitivity C-reactive protein, and soluble intercellular cell-adhesion molecule-1.

There was no significant change in absolute soluble P-selectin concentrations after either diet.

Normalized inflammatory values represented as the delta change per 1 kg reduction in body mass showed a significant difference between the 2 diets only for soluble P-selectin (P < 0.05).

Author Conclusion:

In summary, energy-restricted low-fat and very-low-carbohydrate diets both significantly decreased several biomarkers of inflammation. These data suggest that in the short term, weight loss is primarily the driving force underlying the reductions in most of the inflammatory biomarkers.

Funding Source:

Not-for-profit

Reviewer Comments:

Small sample size. Sample not well defined in terms of recruitment and inclusion/exclusion criteria.

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?		???
	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?	???
	2.2.	Were criteria applied equally to all study groups?	???
	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?		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?		No
	5.1.	In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate?	No
	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?	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)?	N/A
	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