NNNS: Hyperlipidemias (2011)
- "To determine the effect of a diet designed with fat and sugar replacers on metabolic profile, weight and BMI of well controlled type 2 diabeteic patients."
- "To compare the effects of a diet based on the American Diabetes Association's (ADA) nutritional recommendations."
- Well-controlled Type 2 diabetic patients (i.e. fasting plasma glucose between 70mg to 120mg/dL, hemoglobin A1c <8.5%)
- 45 to 55 years old
- Had performed physical activity (e.g. walking 60 minutes in the evening) for three months before starting the study.
- Patients who attended the Endocrine and Metabolic Research Center.
- Daily energy requirements were calculated for each patient through corporal weight and 24-hour MAL behavior questionnaire.
- Patients were randomized into two groups of eight patients each. During the four-week study period, the control group received a diet according to the ADA guidelines. The experimental group was fed a specially modified ADA diet with a ß-glucans-containing fat replacer (Oatrim) and a mixture of natural (fructose) and artificial sweetners [sucralose (Splenda)].
- Two types of modified foods were administered to the experimental group:
- Lipid- and carbohydrate-modified bread prepared with 8% of fat replacer with ß-glucans and 13% oats, with no added fat
- Lipid- and carbohydrate-modified cookies prepared with 50% fat replacer with ß-glucans and no simple sugars. Fructose and sucralose in a ratio of 30:70 were used as sweeteners.
- Data is expressed as mean ± standard error
- Comparisons of parameters in subjects before and after intervention an in changes produced by the two diets were performed with two-tailed Student's T-test
- P<0.05 was considered significant.
Timing of Measurements
- Biochemical and anthropometric measurements were made at baseline and at four weeks.
- Biochemical: Plasma glucose, hemoglobin A1c, triacylglycerides, total cholesterol, high density lipoprotein cholesterol
- Anthrompoemetrics: Height (cm), weight (kg) measured with patient wearing light clothing and without shoes. BMI calculated.
- Diet according to the ADA guidelines.
- A specially modified ADA diet with a ß-glucans-containing fat replacer (Oatrim) and a mixture of natural (fructose) and artificial sweetners [sucralose (Splenda)].
- Initial N: 16 males
- Age: 45 to 55 years
- Other relevant demographics: No statistical difference between the groups regarding baseline biochemical or anthropometric values
- Location: Medical School in La Universidad del Aulia, Maracaibo, Venezuela.
Modified ADA Diet Group: Measures and Confidence Intervals
ADA Diet Group: Measures and Confidence Intervals
Hemoglobin A1c (%)
Significant within diet group differences from baseline vs. treatment; P<0.004, P<0.04, respectively. No statistically significant differences between groups.
Total cholesterol (mg/dL)
Significant within diet group differences from baseline vs. treatment; P<0.02, NS, respectively. No statistically significant difference between groups.
Significant within group difference from baseline vs. treatment only in experimental group (P<0.05). No statisticially signficant difference between groups.
||Significant within group difference from baseline vs. treatment only in experimental group (P<0.0003). No statistically signficant difference between groups.|
Significant within diet groups differences from baseline vs. treatment; P<0.005, P<0.01, respectively. No statistically significant differences between groups.
Significant within diet group differences from baseline vs. treatment; P<0.0001, P<0.02, respectively. Statistically signifcant differences between groups (P< 0.001).
|University/Hospital:||University of Zulia (Venezuala)|
Extrapolation from this study is limited because it was done only in well-controlled males with diabetes. However, findings do provide a foundation for larger research studies on the use of fat and sugar replacers for people with diabetes.
Quality Criteria Checklist: Primary Research
|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|
|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?||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?||No|
|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)||No|
|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?||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?||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?||???|
|5.1.||In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate?||???|
|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.)||???|
|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?||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?||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?||???|
|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)?||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?||No|
|10.||Is bias due to study's funding or sponsorship unlikely?||No|
|10.1.||Were sources of funding and investigators' affiliations described?||Yes|
|10.2.||Was the study free from apparent conflict of interest?||Yes|