DF: Obesity (2008)
Citation:
Study Design:
Class:
- Click here for explanation of classification scheme.
Quality Rating:
Research Purpose:
- To determine how the resting metabolic rate and thermic effect of food in obese persons compares with that in the non-obese
- To determine how the presence of fiber in a meal affects its thermic effect.
Inclusion Criteria:
- Female
- Non-pregnant.
Exclusion Criteria:
Major metabolic or endocrine disorder or any significant disease other than obesity.
Description of Study Protocol:
Recruitment
- Lean subjects were student volunteers
- Obese subjects recruited from the Nutrition Clinic at the All India Institute of Medical Sciences.
Design
- Random assignment to two different meals with and without pectin and cellulose, with measurement of resting metabolic rate using measured oxygen consumption on three diferent days:
- Session A: No meal provided
- Session B
- Energy: 400Kcal
- Carbohydrate: 50g
- Protein: 40g
- Fat: 4.5g.
- Session C: As above, plus 10g cellulose and 10g pectin.
- Obesity was defined at BMI over 27.
Blinding Used
Not applicable.
Intervention
- For each session, oxygen consumption was measured at five-minute intervals until two comparable readings were given
- After the comparable readings were obtained, a meal was given during the second (Session B) and third session (Session C)
- No meal was given in the first session (session A)
- A high-protein meal was given in session B
- In session C the high protein meal incorporated 10g of pectin and 10g of cellulose
- Following the meal time, oxygen consumption was measured every 30 minutes for three hours during all sessions
- The sequence of the sessions was randomized for each subject
- Food intake was measure using a bomb calorimeter:
- Obese subjects were asked to bring duplicate sample of everything eaten on a typical day
- Lean subjects dined on campus and their diet was collected from the foodservice.
Statistical Analysis
- Not described
Data Collection Summary:
Timing of Measurements
- Oxygen consumption: After a test meal, oxygen consumption was measured every 30 minutes for three hours
- Food intake: Obese subjects were asked to bring a duplicate sample of everything eaten on a typical day; lean subjects dined on campus and their diet was collected from the foodservice
- Energy content of diet: Bomb calorimeter.
Dependent Variables
- Oxygen consumption, measured by spirometry on a Benedict-Roth respiration apparatus
- Resting metabolic rate
- Thermic effect of feeding.
Independent Variables
Fiber intake.
Control Variables
None.
Description of Actual Data Sample:
- Initial N: 20 women; eight obese and 12 non-obese
- Attrition (final N): None
- Age: 21.7±2.6 years for lean subjects and 43.6±9.4 years for obese subjects
- Ethnicity: Asian.
Anthropometrics
Mean BMI: 20.0 in lean subjects and 34.4 in obese subjects.
Location
India.
Summary of Results:
Resting Metabolic Rate in Obese and Non-Obese Subjects
Variables |
Whole Group |
Obese Group |
Lean Group |
P-Value, Obese vs. Non-Obese |
Kcal/hr |
75.5±4.35 |
87.3±6.78 |
67.6±4.29 |
<0.02 |
Kcal/kg/hr |
1.2756±0.09 |
1.0817±0.10 |
1.4048±0.13 |
NS |
Kcal/m2/hr |
47.7±2.64 |
49.1±4.03 |
46.9±3.60 |
NS |
Area Under the 3-hr Metabolic Rate Curve, Kcal |
242.0±19.35 |
303.4±30.78 |
201.11±7.18 |
<0.01 |
Other Findings
- No significant difference in energy intake between obese and non-obese subjects
- BMI was found to be negatively correlated with RMR expressed in Kcal per kg per hour (R=-0.56, P<0.001).
- Thermic effect of feeding
- In non-obese subjects, the metabolic rates were significantly different between Session A and Session C at 1.5 and 2.0 hours (P<0.01)
- The obese subjects failed to show an increase in energy expenditure under the influence of meals
- The areas under the three-hour metabolic rate curves showed a significant rise from Session A to Session C in case of non-obese subjects (P<0.05), but for the obese subjects the areas remained essentially constant.
- Effect of fiber on the thermic effect of feeding
- The metabolic rate after the high-protein meal was significantly higher at 0.5 hours than during the control session (A)
- After Session C, the metabolic rate was higher than for the control session (A) at 2.0 hours
- The magnitude of the thermic effect of feeding in the non-obese subjects was 5.93% after the high-protein meal (Session B) and 17% above the control after the high-protein plus fiber meal (Session C).
Author Conclusion:
- The authors tentatively conclude that positive energy balance in the obese may develop at least partially from decreased thermic effect of feeding
- After gaining weight, the larger body mass raises the absolute energy expenditure so that energy balance is achieved at a higher body weight
- Dietary fiber may retard the development of obesity partly by increasing the cost of utilizing food.
Funding Source:
Industry: |
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Reviewer Comments:
- The ages of the lean subjects were much lower and less variable than the ages of the obese subjects
- Age could certainly be a confounding factor, but was not controlled for in this study.
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 | |
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? | 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 | |
1.2. | Was (were) the outcome(s) [dependent variable(s)] clearly indicated? | Yes | |
1.3. | Were the target population and setting specified? | Yes | |
1.3. | Were the target population and setting specified? | Yes | |
2. | Was the selection of study subjects/patients free from bias? | No | |
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 | |
2.1. | 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? | No | |
2.2. | Were criteria applied equally to all study groups? | No | |
2.3. | Were health, demographics, and other characteristics of subjects described? | 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 | |
2.4. | Were the subjects/patients a representative sample of the relevant population? | No | |
3. | Were study groups comparable? | No | |
3. | Were study groups comparable? | No | |
3.1. | Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT) | No | |
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? | No | |
3.2. | Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline? | No | |
3.3. | Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.) | 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 | |
3.4. | 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? | 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 | |
4.1. | 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? | No | |
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 | |
5.1. | 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 | |
5.2. | 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 | |
5.3. | 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? | 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 | |
6.2. | 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 | |
6.3. | 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 | |
6.4. | 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? | No | |
6.5. | Were co-interventions (e.g., ancillary treatments, other therapies) described? | No | |
6.6. | Were extra or unplanned treatments described? | No | |
6.6. | Were extra or unplanned treatments described? | No | |
6.7. | Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups? | 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 | |
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? | No | |
7. | Were outcomes clearly defined and the measurements valid and reliable? | No | |
7.1. | Were primary and secondary endpoints described and relevant to the question? | 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? | ??? | |
7.2. | Were nutrition measures appropriate to question and outcomes of concern? | ??? | |
7.3. | Was the period of follow-up long enough for important outcome(s) to occur? | 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 | |
7.4. | 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? | No | |
7.5. | Was the measurement of effect at an appropriate level of precision? | No | |
7.6. | Were other factors accounted for (measured) that could affect outcomes? | No | |
7.6. | Were other factors accounted for (measured) that could affect outcomes? | No | |
7.7. | Were the measurements conducted consistently across groups? | 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? | No | |
8. | Was the statistical analysis appropriate for the study design and type of outcome indicators? | No | |
8.1. | Were statistical analyses adequately described and the results reported appropriately? | No | |
8.1. | Were statistical analyses adequately described and the results reported appropriately? | No | |
8.2. | Were correct statistical tests used and assumptions of test not violated? | No | |
8.2. | Were correct statistical tests used and assumptions of test not violated? | No | |
8.3. | Were statistics reported with levels of significance and/or confidence intervals? | 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 | |
8.4. | 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)? | No | |
8.5. | Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)? | No | |
8.6. | Was clinical significance as well as statistical significance reported? | No | |
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? | No | |
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. | Are conclusions supported by results with biases and limitations taken into consideration? | Yes | |
9.1. | Is there a discussion of findings? | Yes | |
9.1. | Is there a discussion of findings? | Yes | |
9.2. | Are biases and study limitations identified and discussed? | 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. | Is bias due to study's funding or sponsorship unlikely? | Yes | |
10.1. | Were sources of funding and investigators' affiliations described? | Yes | |
10.1. | Were sources of funding and investigators' affiliations described? | Yes | |
10.2. | Was the study free from apparent conflict of interest? | Yes | |
10.2. | Was the study free from apparent conflict of interest? | Yes | |