EAL

NNNS: Hyperlipidemias (2011)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

"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."

Inclusion Criteria:

Male
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
Non-smokers
Had performed physical activity (e.g. walking 60 minutes in the evening) for three months before starting the study.

Exclusion Criteria:

None listed.

Description of Study Protocol:

Recruitment

Patients who attended the Endocrine and Metabolic Research Center.

Design

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)].

Intervention

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.

Each patient in the experimental group consumed two daily bread units and three cookies throughout the study period
The patients in the control group consumed a diet that was consistent with ADA recommendations.

Statistical Analysis

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.

Data Collection Summary:

Timing of Measurements

Biochemical and anthropometric measurements were made at baseline and at four weeks.

Dependent Variables

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.

Independent Variables

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)].

Description of Actual Data Sample:

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.

Summary of Results:

Variables	Modified ADA Diet Group: Measures and Confidence Intervals	ADA Diet Group: Measures and Confidence Intervals	Statistical Significance
Hemoglobin A1c (%) Before Treatment After Treatment	8.1±0.1 7.7±0.1	8.5±0.2 8.3±0.2	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) Before Treatment After Treatment	207.6±9.0 192.8±9.5	223.6±17.7 217.2±15.3	Significant within diet group differences from baseline vs. treatment; P<0.02, NS, respectively. No statistically significant difference between groups.
LDL-cholesterol (mg/dL) Before Treatment After Treatment	135.7±7.7 125.8±6.3	141.8±10.9 140.5±15.7	Significant within group difference from baseline vs. treatment only in experimental group (P<0.05). No statisticially signficant difference between groups.
HDL-cholesterol (mg/dL) Before Treatment After Treatment	33.0±1.8 38.6±2.2	35.0±2.6 35.5±2.7	Significant within group difference from baseline vs. treatment only in experimental group (P<0.0003). No statistically signficant difference between groups.
Weight (kg) Before Treatment After Treatment	79.1±11.0 75.9±10.5	83.0±6.2 81.5±5.7	Significant within diet groups differences from baseline vs. treatment; P<0.005, P<0.01, respectively. No statistically significant differences between groups.
BMI Before Treatment After Treatment	28.5±1.7 27.3±1.7	28.9±2.0 28.5±1.7	Significant within diet group differences from baseline vs. treatment; P<0.0001, P<0.02, respectively. Statistically signifcant differences between groups (P< 0.001).

Author Conclusion:

"Treatment of male, well controlled type 2 diabetic patients for 4 weeks with a diet containing fat replacer and non-sucrose sweetener improved metabolic control by increasing HDL-c and by promoting a greater decrease in Hg A1c, as well as demonstrated higher weight loss and BMI reduction when compared with a diet based on ADA's nutrition recommendation."

Funding Source:

Government:	USDA
University/Hospital:	University of Zulia (Venezuala)

Reviewer Comments:

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
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?	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