EAL

NNNS: Diabetes and Glycemic Response (2011)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

Do artificial sweeteners impact blood glucose vs. patients using regular table sugar?

Inclusion Criteria:

Between 58-82 years old
Overweight or adipose (BMI 24-36.1)
Hypertensive
Pre-diabetic
Fasting blood sugar between 96-125mg/dL.

Exclusion Criteria:

Non-adipose (BMI<24)
Non-hypertensive
Not pre-diabetic
Normal FBG.

Description of Study Protocol:

Recruitment

Method unclear

Design

Non-randomized triple cross-over design

Blinding used

Unclear

Intervention

Three test trials were performed one hour after lunch at intervals of several weeks and followed by a one month testing-free interval. Within each trial each patient consumed 150ml test solution containing either 6g of table sugar, sweetener ("Kandisin", a blend of saccharin and cyclamic acid) or an unsweetened control. Patients determined blood glucose concentration using a blood sugar measuring system before and five, 15, 30 and 60 minutes after intake.

Statistical Analysis

Analysis of variance

Data Collection Summary:

Timing of Measurements

Tests performed within one hour after lunch to ensure conditions comparable to patients having a dessert
Patients determined their blood glucose concentration before and five, 15, 30 and 60 minutes after the intake of the test solution.

Dependent Variables

Blood glucose levels before and five, 15, 30 and 60 minutes after the intake of the test solution

Independent Variables

Blood glucose concentration at five time points

Control Variables

Content of test solution

Description of Actual Data Sample:

Initial N: N=16
- Five women
- 11 men
Attrition (final N): Unclear
Age: 58-82 years old
Ethnicity: Unknown
Anthropometrics: BMI=24-36.1
Location: Interuniversity College for Helath and Development Graz, Castle of Seggau, Austria.

Summary of Results:

Changes in blood glucose concentration within the different measured time points.

Time Points	Sugar	Sweetener*	Control
Before	No significant change¹	No significant change²	Change
Five minutes	No significant change	No significant change	Change
15 minutes	No significant change	No significant change	Change
30 minutes	No significant change	No significant change	Change
60 minutes	No significant change	No significant change	Significant decrease over 60 minutes³^,ε

* "Kandisin" (saccharin + cyclamic acid)

¹ P=0.175

² P>0.05

³ P=0.020

^ε Decrease on concentration attributable to physiological reaction of the body

Author Conclusion:

Based on the collected data no significant changes in the blood glucose concentration could be reached within the different time points, except with the control group (no sweetener or sugar) over a time frame of 60 minutes, which was attributable to a normal physiological reaction
The results of this pilot study do not indicate artificial sweeteners or regular table sugar have any impact on hunger stimulation or blood sugar concentration
Study of the psychosomatic purported "cephalic insulin reflex, which induces a decrease in blood glucose and is interpreted by the hypothalamus as a sign of hunger, would have required intravenous blood analysis
It is unclear whether the substitution of table sugar with artificial sweeteners have an influence on the dietary food intake in society and thus influence weight change.

Funding Source:

University/Hospital:

Interuniversity College for Helath and Development Graz, Castle of Seggau, Austria

Reviewer Comments:

Randomization of the subjects in the three test trials unclear
Subjects self-reported blood glucose results.

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?	Yes
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?		No
	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%.)	No
	4.3.	Were all enrolled subjects/patients (in the original sample) accounted for?	???
	4.4.	Were reasons for withdrawals similar across groups?	???
	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?	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?	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)?	Yes
	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?	No
9.	Are conclusions supported by results with biases and limitations taken into consideration?		No
	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?		???
	10.1.	Were sources of funding and investigators' affiliations described?	No
	10.2.	Was the study free from apparent conflict of interest?	???