Disorders of Lipid Metabolism and Nuts
To observe the effect of almond consumption on insulin sensitivity of free-living healthy persons. (Study 2 published in the same article is found in a separate worksheet).
- Healthy men and women
- Normal blood chemistry values
- Normal hematocrit
- Fasting glucose <120 mg/dL
- Pregnant or breast-feeding
- Food allergies or sensitivity to nuts
Baseline assessments
4 wk dietary supplementation with 100g almonds
- habitual diet maintained
- urged to reduce intake to avoid wt gain
- 3 days dietary record/wk
at end 4 wk, baseline assessments repeated
Assessed at baseline & after 4 wk almond supplementation
- Insulin- modified frequently sampled intraveneous-glucose-tolerance
- Fasting TC
- Fasting LDL-C
- Fasting HDL-C
- Fasting TG
10 men, 10 women
Ethnicity not reported
BMI 18-30, mean 23.0
Age 20-50 y, mean 25.1 y
No drop outs
Body wt increased slightly but sig (0.9 kg in males, 0.3 kg in females, p=0.006)
Dietary intake, changes from baseline (self-selected & sel-reported other than 100g almonds). Values only given in a bar graph.
- Energy increased insig
- Fat (%Calories) increased sig by unstated amt. (p<0.05)
- Carb (% Calories) decreased sig by unstated amt (p<0.05)
No sig dif baseline vs final in insulin sensitity or glucose effectiveness (see table)
- Men had decreases; females increases, approaching sig.
Lipid profile (see table)
- TC sig decreased
- LDL-C sig decreased
- HDL-C sig dcreased, sig more in males
- TC/HDL & LDL/HDL decreased
- TG no sig effects
See Table 1.
before after Main effect time Main effect sex Sex X time Men Women men women Body wt, Kg 77.2 + 2.3 57.5 + 2.3 78.1+2.33 57.8+2.3 0.006 0.0001 ns Insulin sensitivity index (X10 –4 min-1. micro U-1. mL-1) 3.31+0.41 4.75+0.41 3.73+0.41 3.85 +0.41 ns ns 0.04 Glucose effectiveness (min –1 X 102) 2.14+0.17 2.71+0.17 2.38+0.17 2.33+0.17 ns ns 0.006 Chols (mmol/L) 4.50+ 0.18 4.75+0.18 3.59+0.18 3.70+0.18 0.0001 ns ns LDL-C (mmol/L) 3.01+0.16 3.02+0.16 2.22+0.16 2.10+0.16 0.0001 ns ns HDL-C (mmol/L) 1.0+0.05 1.40+0.05 0.88+0.05 1.22+0.05 0.0002 0.0001 ns TC/HDL 4.51+0.24 3.65+0.24 4.11+0.24 3.08+0.24 0.003 0.006 ns LDL/HDL 3.02+0.20 2.37+0.20 2.54+0.20 1.76+0.20 0.0005 0.01 ns
Almond consumption did not change insulin sensitivity, did increase body wt and decreased TC and LDL-C.
Industry: |
|
||
University/Hospital: | Louisiana State University |
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 | |
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 | |
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 | |
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 | |
4. | Is the intervention or procedure feasible? (NA for some epidemiological studies) | Yes | |
Validity Questions | |||
1. | Was the research question clearly stated? | Yes | |
1. | Was the research question clearly stated? | Yes | |
1.1. | Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified? | N/A | |
1.1. | Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified? | N/A | |
1.2. | Was (were) the outcome(s) [dependent variable(s)] clearly indicated? | N/A | |
1.2. | Was (were) the outcome(s) [dependent variable(s)] clearly indicated? | N/A | |
1.3. | Were the target population and setting specified? | N/A | |
1.3. | Were the target population and setting specified? | N/A | |
2. | Was the selection of study subjects/patients free from bias? | 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? | N/A | |
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? | N/A | |
2.2. | Were criteria applied equally to all study groups? | N/A | |
2.2. | Were criteria applied equally to all study groups? | N/A | |
2.3. | Were health, demographics, and other characteristics of subjects described? | N/A | |
2.3. | Were health, demographics, and other characteristics of subjects described? | N/A | |
2.4. | Were the subjects/patients a representative sample of the relevant population? | N/A | |
2.4. | Were the subjects/patients a representative sample of the relevant population? | N/A | |
3. | Were study groups comparable? | N/A | |
3. | Were study groups comparable? | N/A | |
3.1. | Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT) | N/A | |
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 | |
3.2. | 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.) | N/A | |
3.3. | Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.) | N/A | |
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 | |
3.4. | 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 | |
3.5. | 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 | |
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. | Was method of handling withdrawals described? | Yes | |
4.1. | Were follow-up methods described and the same for all groups? | 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 | |
4.2. | 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 | |
4.3. | Were all enrolled subjects/patients (in the original sample) accounted for? | N/A | |
4.4. | Were reasons for withdrawals similar across groups? | N/A | |
4.4. | 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 | |
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. | 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? | N/A | |
5.1. | In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate? | N/A | |
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.) | N/A | |
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.) | N/A | |
5.3. | In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded? | N/A | |
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 | |
5.4. | 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 | |
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. | 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? | N/A | |
6.1. | In RCT or other intervention trial, were protocols described for all regimens studied? | N/A | |
6.2. | In observational study, were interventions, study settings, and clinicians/provider described? | N/A | |
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? | N/A | |
6.3. | Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect? | N/A | |
6.4. | Was the amount of exposure and, if relevant, subject/patient compliance measured? | N/A | |
6.4. | Was the amount of exposure and, if relevant, subject/patient compliance measured? | N/A | |
6.5. | Were co-interventions (e.g., ancillary treatments, other therapies) described? | N/A | |
6.5. | Were co-interventions (e.g., ancillary treatments, other therapies) described? | N/A | |
6.6. | Were extra or unplanned treatments described? | N/A | |
6.6. | 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? | N/A | |
6.7. | Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups? | N/A | |
6.8. | In diagnostic study, were details of test administration and replication sufficient? | N/A | |
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. | Were outcomes clearly defined and the measurements valid and reliable? | Yes | |
7.1. | Were primary and secondary endpoints described and relevant to the question? | N/A | |
7.1. | Were primary and secondary endpoints described and relevant to the question? | N/A | |
7.2. | Were nutrition measures appropriate to question and outcomes of concern? | N/A | |
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? | N/A | |
7.3. | Was the period of follow-up long enough for important outcome(s) to occur? | N/A | |
7.4. | Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures? | N/A | |
7.4. | Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures? | N/A | |
7.5. | Was the measurement of effect at an appropriate level of precision? | N/A | |
7.5. | Was the measurement of effect at an appropriate level of precision? | N/A | |
7.6. | Were other factors accounted for (measured) that could affect outcomes? | N/A | |
7.6. | Were other factors accounted for (measured) that could affect outcomes? | N/A | |
7.7. | Were the measurements conducted consistently across groups? | N/A | |
7.7. | Were the measurements conducted consistently across groups? | N/A | |
8. | Was the statistical analysis appropriate for the study design and type of outcome indicators? | 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? | N/A | |
8.1. | Were statistical analyses adequately described and the results reported appropriately? | N/A | |
8.2. | Were correct statistical tests used and assumptions of test not violated? | N/A | |
8.2. | Were correct statistical tests used and assumptions of test not violated? | N/A | |
8.3. | Were statistics reported with levels of significance and/or confidence intervals? | N/A | |
8.3. | Were statistics reported with levels of significance and/or confidence intervals? | N/A | |
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 | |
8.4. | 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)? | N/A | |
8.5. | Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)? | N/A | |
8.6. | Was clinical significance as well as statistical significance reported? | N/A | |
8.6. | Was clinical significance as well as statistical significance reported? | N/A | |
8.7. | If negative findings, was a power calculation reported to address type 2 error? | N/A | |
8.7. | If negative findings, was a power calculation reported to address type 2 error? | N/A | |
9. | Are conclusions supported by results with biases and limitations taken into consideration? | Yes | |
9. | Are conclusions supported by results with biases and limitations taken into consideration? | Yes | |
9.1. | Is there a discussion of findings? | N/A | |
9.1. | Is there a discussion of findings? | N/A | |
9.2. | Are biases and study limitations identified and discussed? | N/A | |
9.2. | Are biases and study limitations identified and discussed? | N/A | |
10. | Is bias due to study's funding or sponsorship unlikely? | Yes | |
10. | Is bias due to study's funding or sponsorship unlikely? | Yes | |
10.1. | Were sources of funding and investigators' affiliations described? | N/A | |
10.1. | Were sources of funding and investigators' affiliations described? | N/A | |
10.2. | Was the study free from apparent conflict of interest? | N/A | |
10.2. | Was the study free from apparent conflict of interest? | N/A | |