EAL

DM: Carbohydrates (2007)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To assess in diabetic subjects the effects of dietary sucrose on glycemia and lipemia.

Inclusion Criteria:

Type II diabetes.

Exclusion Criteria:

None specifically mentioned.

Description of Study Protocol:

Recruitment not specified

Design : 12 patients consumed, in random order, two isocaloric diets for 28 days

Blinding used (if applicable): not used

Intervention (if applicable)

high sucrose diet: 19% of energy derived from sucrose
high starch diet <3% of energy from sucrose
high fructose diet (results not reported in this study, but published elsewhere)
all diets were 55% CHO, 15% protein, 30% fat
dietary fiber, cholesterol, PUFA, MUFA, and saturated fat were nearly identical for all diets
subjects lived at home, but ate breakfast and dinner at the research kitchen, lunch was prepared and sent along with subjects.

Statistical Analysis

comparisons between the study diets at days 1, 14, 21, and 28 were two-sided and performed by paired Stduent's t-test.
Bonferroni procedure used to protect against the effects of multiple comparisons

Data Collection Summary:

Timing of Measurements

blood samples drawn on day 1, 14, 21, and 28 of each diet period
fasting blood samples were obtained 30 minutes before breakfast 0730) on those days
additional blood samples were drawn at 0900, 1000,1200, 1330, 1430, 1630, 1800, 1900, 2100, 2230, and 2330

Dependent Variables

fasting plasma glucose
fasting serum cholesterol, HDL, and triglyceride
urine glucose
serum LDL

Independent Variables:

high sucrose diet: 19% of energy derived from sucrose
high starch diet <3% of energy from sucrose
high fructose diet (results not reported in this study, but published elsewhere)
all diets were 55% CHO, 15% protein, 30% fat
dietary fiber, cholesterol, PUFA, MUFA, and saturated fat were nearly identical for all diets
subjects lived at home, but ate breakfast and dinner at the research kitchen, lunch was prepared and sent along with subjects.
subjects discouraged from strenuous exercise, but encouraged to continue normal activity

Control Variables

Description of Actual Data Sample:

Initial N: 12, 8 women

Attrition (final N):12

Age: 62 yrs

Ethnicity: not specified

Other relevant demographics: mean duration of diabetes = 7 yrs; 5 treated with diet alone, 5 treated with insulin, and 2 treated with oral hypoglycemics; all had urinary C peptide > 10.0 mmol/24h

Anthropometrics mean relative weight of 136%

Location: United States

Summary of Results:

Mean values at day 28

Variables	Sucrose Diet	Starch Diet	P value
Mean plasma glucose (mM)	9.6±0.4	9.4±0.6	0.63
urine glucose (g/24h)	1.0±0.3	1.6±0.7	0.26
Fasting serum cholesterol, (mM)	5.05±0.27	4.9±0.27	0.41
Fasting serum HDL,(mM)	1.05±0.07	1.02±0.07	0.17
Fasting serum LDL, (mM)	3.12±0.26	3.08±0.21	0.81
Fasting serum TG, (mM)	1.91±0.21	1.77±0.23	0.26
Peak postprandial serum TG, (mM)	2.64±0.27	2.34±0.25	0.08

Other Findings

Author Conclusion:

A diet deriving 19% of energy from sucrose did not cause an increase in glycemia relative to a diet deriving charbohydrate energy from starch.

Dietary sucrose did not significantly increase fasting or peak postprandial serum glucose.

Funding Source:

Government:

GCRC, NIH

Industry:

International Fructose Association (Switzerland)

Commodity Group:

Reviewer Comments:

No information given about the way in which the sucrose and fructose were included in the diets.

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?	No
	2.2.	Were criteria applied equally to all study groups?	N/A
	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?	???
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)	N/A
	3.2.	Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline?	N/A
	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?	N/A
	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?	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?	N/A
	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?	No
	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?	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