EAL

MNT: Weight Management (2015)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To elucidate the impact of two types of individualized weight reduction diets on weight loss and on parameters of glucose and lipid metabolism.

Inclusion Criteria:

Adult
Obese
Non-diabetic subjects or patients with type 2 diabetes.

Exclusion Criteria:

Presence of pancreatic, biliary or thyroid diseases.

Description of Study Protocol:

Recruitment

Recruited from Middle Bohemia, the Czech Republic, using advertisements placed in local newspapers and from the diabetic clinic.

Design

Randomized controlled trial that lasted three months.

Intervention

Diets were individually calculated for kcal content. The menus were either prescribed or individually approved by the dietitian
Conventional diet was a standard diabetic diet consisting of:
- 60% carbohydrate (CHO) 10% protein, and 30% fat
- Cholesterol content was less than 300mg
- Fat breakdown was 10% MUFA, 10% PUFA and 10% SFA
Experimental diet was a high-fat diet enriched with MUFA consisting of:
- 45% CHO, 10% protein, and 45% fat
- Dietary cholesterol was less than 300mg
- Fat content was 22.5% MUFA, 11.25% SFA and 11.25 % PUFA.

Statistical Analysis

Paired Student T-test (for the comparison of initial and final data differences in each group)
ANOVA for the comparison of the data among the groups in the test periods.

Data Collection Summary:

Timing of Measurements

The subjects visited with a dietitian every two weeks and a physician every month
The subjects were measured at baseline, monthly during the experiment and at the end of the third month for physical, anthropometric and lab testing.

Dependent Variables

Anthropometrics (weight, height, waist and hip measurements, skin fat, muscle strength, BMI)
Metabolic parameters (total cholesterol, triglycerides, HDL, fasting blood glucose were assayed on a Konelab analyzer).
- LDL was calculated using the Friedewald equation
- Insulin and C-peptide were analyzed using a Vitros ECI analyzer
- HbA1c was assayed using a DS5 analyzer
- HOMA index was calculated.

Independent Variables

Experimental hypocaloric high-fat diet enriched with MUFA vs. a conventional diabetic diet
Once every two weeks a dietitian monitored compliance with the diet by checking diet records and diet tolerance.

Description of Actual Data Sample:

Initial N: 27 obese, type 2 diabetic and 31 obese non-diabetic subjects, gender was not stated
Attrition (final N): As above
Age: 45 to 60 years; mean age type 2 diabetics = 54.5±3.5 years, non-diabetics = 53.6±3.5 years
Anthropometrics: BMI ranged from 26 to 38kg/m². No differences were found between the diabetic patients and the obese subjects in any of the metabolic parameters, except for blood glucose and HbA1c
Location: Czech Republic.

Summary of Results:

Key Findings

After three months, body weight, waist-hip ratio, total body fat, levels of C-peptide, triglycerides and HOMA decreased in all four groups (diabetics on MUFA diet, diabetics on control diet, obese subjects on MUFA diet and obese subjects on the control diet, P<0.001)
Fasting blood glucose and HbA1c values decreased significantly (P<0.01) in the diabetics on MUFA diet
HDL cholesterol increased significantly (P<0.05) in the diabetics on MUFA diet.

Other Findings

All the groups were able to lower their energy intake for the duration of the study
12% of the participants said they wanted to eat less food because they thought they had an unbearably large amount of food to eat
In contrast, 40% of the subjects had to have an additional reduction of kcals by -250kcal per day (after four weeks) to continue to produce weight loss
Most of the subjects (78%) were well satiated on the diets.

Author Conclusion:

Individualized metabolic and conventional diets were successful in improving metabolic and anthropometric parameters in both the obese, non-diabetic and the subjects with type 2 diabetes
Although the superiority of the higher fat diet did not reach statistical significance, subjects with type 2 diabetes on the metabolic diet experienced a decline in blood glucose and HbA1c values.

Funding Source:

University/Hospital:

Charles University and the University Hospital, Kralovske Vinohrady

Reviewer Comments:

Sample was not well-described
Authors note the following limitations:
- Size of study limited statistical power to detect differences between diets
- Study was designed as a weight reduction program, so it was difficult to distinguish between the positive metabolic effects because of the weight loss itself from the possible positive effects of macronutrient composition.

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?	No
	2.4.	Were the subjects/patients a representative sample of the relevant population?	???
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)	Yes
	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?		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?	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.)	Yes
	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?	No
	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?	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?	???
	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?	Yes
	8.2.	Were correct statistical tests used and assumptions of test not violated?	No
	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)?	???
	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?	Yes
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