EAL

PDM: Metabolic Syndrome (2013)

Citation:

Konig D, Theis S, Kozianowski G, Berg A. Postprandial substrate use in overweight subjects with the metabolic syndrome after isomaltulose (Palatinose™) ingestion. Nutrition. 2012; 28(6): 651-656.

PubMed ID: 22264450

Study Design:

Randomized Crossover Trial

Class:

A - Click here for explanation of classification scheme.

Quality Rating:

NEUTRAL: See Quality Criteria Checklist below.

Research Purpose:

To investigate the postprandial metabolic response after an intake of breakfast and lunch that contained 50g of the low GI carbohydrate isomaltulose or a combination of glucose syrup and sucrose (1:1 gucose to sucrose) with a higher GI and load, respectively.

Inclusion Criteria:

Provided written informed consent
Free from acute diseases, overweight or obese (BMI higher than 25kg/m²)
Had a normal physical activity profile (no athletes or endurance-trained subjects)
Able to carry out a physical activity protocol
Fulfilled three of five of the National Cholesterol Education Program/Adult Treatment Panel III (NCEP/ATP III) criteria for the metabolic syndrome
Waist circumference more than 102cm, triacylglycerol level higher than 150mg per dL, high-density lipoprotein cholesterol less than 40mg per dL, blood pressure higher than 130/85mm Hg, fasting blood glucose level higher than 100mg per dL and were insulin resistant according to a homeostasis model assessment index higher 25(insulin uU per ml) x blood sugar (mg per dL).

Exclusion Criteria:

Contraindications to physical exercise, type 1 diabetes, liver and kidney impairments
Psychiatric disorders, other disorders of an acute or chronic nature (gastrointestinal, pulmonary, renal, cardiac, neurological or psychiatric disorders)
Any known allergies to foods or their ingredients
Use of weight reducing preparations or appetite suppressants
Participation in a clinical study within 30 days before the beginning of the study or during the study
Any use of beta-blockers, oral anti-diabetic medications and insulin therapy.

Description of Study Protocol:

Design

Randomized crossover trial.

Blinding Used

Double-blind.

Intervention

Intake of breakfast and lunch that contained 50g of the low GI carbohydrate isomaltulose
Intake of breakfast and lunch that contained a combination of glucose syrup and sucrose (1:1 glucose to sucrose) with a higher GI and load respectively
- In the morning after an overnight fast (12 hours) each subject consumed in a randomized fashion a breakfast (891kcal) consisting of 250ml drink with 25g of Palatinose or glucose to sucrose (1:1) and 140g of cookies containing 60g of carbohydrate, of which 25g was from Palatinose or glucose to sucrose
- Two hours after breakfast, subjects exercised at moderate intensity on a treadmill for 30 minutes followed by a 30-minute post-exercise regeneration period.
- 180 minutes after breakfast, subjects ingested lunch (640kcal) consisting of 250ml beverage with 25g of Palatinose or glucose to sucrose and a standardized mini pizza and a medium sized apple (125g).

Statistical Analysis

Statistical analysis was performed using the SPSS 17.0 for Windows (SPSS Inc., Chicago IL, USA)
Data are presented as mean ±SD
The testing for differences between the two test meals was done by the Wilcoxon rank sum test; P≤0.05 was considered statistically significant.

Data Collection Summary:

Timing of Measurements

Measurements were made at zero, 15, 30, 45, 60, 90, 120, 150, 165, 180, 240, 300, 360 and 420 minutes.

Dependent Variables

Postprandial metabolic response: Blood levels of glucose, oxygen uptake and carbon dioxide production were determined at zero, 15, 30, 45, 60, 90, 120, 150, 165, 180, 240, 300, 360 and 420 minutes. Insulin concentrations were determined at each time point until lunch.
Triacylglycerols, cholesterols, cortisol, and non-esterified fatty acids were analyzed from venous blood samples at fasting (zero minutes, 120 minutes after breakfast, after exercise (150 minutes) and three hours after the standardized lunch meal (360 minutes)
The ratio of carbon dioxide production to oxygen consumption (respiratory quotient, respiratory exchange ratio) was calculated, and the energy expenditure and fat oxidation were determined according to the equation of Weir. The total fat oxidation over the test periods was derived from the area under the curve calculated by the trapezoid method.

Independent Variables

Intake of breakfast and lunch that contained 50g of the low GI carbohydrate isomaltulose
Intake of breakfast and lunch that contained a combination of glucose syrup and sucrose (1:1 glucose to sucrose) with a higher GI and load respectively
- In the morning after an overnight fast (12 hours), each subject consumed in a randomized fashion a breakfast (891kcal) consisting of a 250ml drink with 25g of Palatinose or glucose to sucrose (1:1) and 140g of cookies containing 60g of carbohydrate, of which 25g was from Palatinose or glucose to sucrose
- Two hours after breakfast, subjects exercised at moderate intensity on a treadmill for 30 minutes followed by a 30-minute post-exercise regeneration period
- 180 minutes after breakfast, subjects ingested lunch (640kcal) consisting of 250ml beverage with 25g of Palatinose or glucose to sucrose and a standardized mini pizza and a medium sized apple (125g).

Description of Actual Data Sample:

Initial N: 20 men
Attrition (final N): 20 men
Age: mean 50.7±9.8 years (range 32 to 64 years)
Anthropometrics:
- Mean BMI (kg/m²) 32.1±3.3
- Mean glucose (mg per dL) 105±15.1
Location: Germany.

Summary of Results:

Key Findings

The glycemic and insulinemic responses were considerably lower after the ingestion of Palatinose (incremental area under the curve, P<0.05)
The total fat oxidation was significantly higher with Palatinose from breakfast to the beginning of lunch, including the exercise and post-exercise periods (P<0.05)
Fat oxidation was numerically higher throughout the entire examination period (P=0.09)
Triacylglycerol and cholesterol levels (total, LDL, HDL, VLDL) analyzed at fasting, two hours after breakfast, after exercise and three hours after lunch were similar in both interventions
Postprandial blood glucose levels were lower after the breakfast with isomaltulose compared with glucose syrup and sucrose for the complete two-hour postprandial period (P=0.002). In the post-exercise period, blood glucose levels reached a maximum one hour after lunch in both groups. However, the subsequent decrease of blood glucose was less pronounced and slower in the second postprandial three-hour period after lunch.

Author Conclusion:

In obese subjects with insulin resistance and metabolic syndrome, the partial substitution of carbohydrates with a higher glycemic index in foods and drinks by Palatinose resulted in greater postprandial fat oxidation at rest and during physical activity. It is hypothesized that this increased fat oxidation may confer further benefits for long-term weight management and for an improvement in metabolic risk factors.

Funding Source:

Industry:

Beneo

Food Company:

Reviewer Comments:

Relatively small sample size.
Only men were studied.
Study was funded by Beneo, the manufacturers of Palatinose.

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?		No
	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?	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)	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?	Yes
	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?	Yes
	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?	Yes
	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?	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?	No
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?		???
	10.1.	Were sources of funding and investigators' affiliations described?	Yes
	10.2.	Was the study free from apparent conflict of interest?	???