DF: Cardiovascular Disease (2008)
To examine the impact of fructooligosaccharides on serum acetate, fasting glucose, triacylglycerol and cholesterol levels in men and post-menopausal women with type 2 diabetes.
- Men and post-menopausal women
- Type 2 diabetes
- Patients from five medical practices in Nijmegen, Netherlands
- Fasting blood glucose over 6.5mmol per L
- Fasting cholesterol over 6.0 mmol per L.
- Gastrointestinal disease
- Antibiotic treatment or laxative use during three months prior to study.
Recruitment
20 patients with type 2 diabetes from five medical practices of general practitioners in Nijmegen, Netherlands.
Design
- Subjects were randomized to consume either 15g fructooligosaccharides (FOS) or four grams glucose (placebo) for 20 days. They were then crossed over to the alternate therapy with no washout period
- All subjects received dietary advice aimed at glycemic control
- Subjects kept a diary of GI tolerance, medication use and lifestyle behaviors
- Subjecs recorded habitual intake in two-day food diaries during each of the two study periods
- Fasting levels of the following were measured at Days One, 18, 21, 39 and 42:
- Blood glucose (by glucometer)
- Serum lipids
- Serum acetate.
Blinding Used
Single-blinded (not described).
Intervention
- Subjects were randomly assigned to receive 15g FOD vs. four grams glucose (placebo), provided in yogurt split into two doses (breakfast and dinner)
- Doses of FOS were introduced gradually during the first three days in five-gram increments
- Subjects were instructed to maintain eating and drinking habits and asked not to consume any probiotic supplements.
Statistical Analysis:
- Analysis of variance, including patient and treatment (period added with no significant differences)
- Paired T-tests
- SDs of effects calculated.
Timing of Measurements
The following were measured Days One, 18 and 21 (Period One) and Days 39 and 42 (Period Two):
- Fasting blood glucose
- Lipids
- Acetate.
Dependent Variables
- Blood glucose
- Serum lipids (total cholesterol, LDL, HDL, triacylglycerol, FFA)
- Serum acetate.
Independent Variables
- Fructooligosaccharides (15g)
Control Variables
- Sex
- Physical activity
- Medications
- Food, drinking, lifestyle behavior.
- Initial N: 20 (nine males, 11 post-menopausal females)
- Attrition (final N): 20 (100%)
- Age: 56±5.2 (men); 62±4.1 (women)
- Ethnicity: Dutch.
Other Relevant Demographics
- No significant differeneces in BMI, body weight, energy, fiber or macronutrient intake
- 17 subjects used oral hypoglycemic agents.
Anthropometrics
BMI: 29.4±4.22 (men) and 27.4±2.72 (women).
Location
Nijmegen, Netherlands.
Dietary Intake
|
Placebo |
FOS |
Energy |
6.6±3.2 |
6.1±2.1 |
Carbohydrate (%) |
38.5%±7.5 |
39.4%±7.2 |
Fiber (g/MJ) |
2.1±0.9 |
2.1±0.8 |
Lipids
- No significant difference between groups
- TC (95% CI: -0.07, 0.48)
- HDL-C (-0.04, 0.04)
- LDL-C (-0.06, 0.34)
- TG (-0.21, 0.44)
- FFA (-0.08, 0.04).
- Eight patients had higher TC after placebo than after fructooligosaccharide
- 11 patients had lower TC after placebo than after fructooligosaccharide
- One patient showed no difference.
Glucose
- No significant difference between groups
- BG (-0.37, 0.40).
- 11 patients had higher glucose levels after placebo than after fructooligosaccharide
- Eight patients had lower glucose levels after placebo than after fructooligosaccharide
- One patient had no difference.
Acetate
- No significant difference between groups
- Serum acetate- (-0.01, 0.01).
Other Findings
- GI complaints higher in FOS group (P=0.008)
- No differences found between men and women by treatment
- Baseline lipid levels lower than expected.
Fructooligosaccharides supplementation for 20 days did not have significant effects on blood glucose and lipid levels in patients with type 2 diabetes under strict medical control.
Government: | Netherlands Ministry for Agriculture, Nature Management and Fishery, | ||
Industry: |
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Not-for-profit |
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- Small sample size
- No washout period
- Glucose measured by glucometer.
Quality Criteria Checklist: Primary Research
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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? | Yes | |
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? | Yes | |
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%.) | 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? | Yes | |
6.6. | Were extra or unplanned treatments described? | Yes | |
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? | No | |
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? | No | |
10.2. | Was the study free from apparent conflict of interest? | Yes | |