EAL

NNNS: Appetite (2006)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To examine the effects of four breakfast preloads of different sweetness and energy content on motivational ratings, taste preferences, and energy intakes of 12 obese and 12 lean women.

Inclusion Criteria:

good health and not on medication
women
BMI values for 41.1 for obese and 21.1 for lean women
non-smokers and non-dieters
reported that their weights were stable; they had not gained or lost weight during the previous year, and they were not currently dieting to lose weight
restraint scores 15.9 for obese women, and 7.9 for lean women

Exclusion Criteria:

didn't meet criteria above

Description of Study Protocol:

Recruitment advertisements placed in a Paris newpaper. Normal weight women were recrutied by advertising at the University of Paris VI and at the Bichat Hospital.

Design and Intervention

The four breakfast preloads were composed of soft dessert type white cheese (fromage blanc) manufactured by Gervais-Danone(Levallois France). the cheese contained 3 g fat, 8g protein and 4 g carbohydrate per 100g product. Creamy white cheese is a common breakfast food in France.

Composition of breakfast preloads
	A	B	C	D
Fromage blanc (g)	400	400	400	400
Sucrose (g)	50
Maltodextrin (g)	50	100
Water (g)			100	100
Carrageenan (g)			0.6	0.6
Aspartame (g)		0.5	0.5
Energy value (kJ)	2929	2929	1255	1255
Energy value (kcal)	700	700	300	300

The subjects took part in all four preload conditions. They were assigned to conditions in the order of their arrival in the laboratory on the first day of testing. The four experiments were scheduled on the same weekday for four consecutive weeks and their order was counterbalanced using a Latin Square design.

Statistical Analysis Analyses of energy and the nutrient content of foods were based on food composition tables and data supplied by the manufacturers. Energy intakes were analyzed using BMDP Anova for repeated measures. body weight was a between subject variable, while preloads and meal type were within subject variables. Tests of significance for differences between means were based on paired t-tests.

Taste preferences were analyzed using BMDP Anova for repeated measures, using body weight, preload ingestion, preload type and fat and sugar levels as independent variables. analyses of motivational ratings used preload type and time of day as independent variables.

Data Collection Summary:

Timing of Measurements

Sensory Stimuli- taste samples, held at 5 degrees C, were presented in a random order in 30 mL plastic cups. Each sample was rated along 9-point unipolar ategory scales anchored with appropriate adjectives at either end. ( not at all sweet and extremely sweet, not at all fat, and extremely fat. Ratings of stimulus acceptability or hedonic preference with not at all god and extremely good.
Food intake- the subjects ate buffet style ( 21 of the same foods) in the laboratory for lunch, snack and dinner meals. The only beverages allowed were tap water and decaffeinated herbal tea. The subjects were instructed to select foods ad lib and to weigh portions of each food on individual paper plates using a digital balance. Experimenter weighed the plates and uneaten food. The subjects were instructed not to consume any food or beverage outside the laboratory on experimental days.
Motivation to Eat -measures of hunger, satiey and the desire to eat were obtained using a 9-point category scales anchored at each end with not at all and extremely.

Timing of Measurements:

0900 h- subjects arrived in laboratory following an overnight fast. they were weighed and measured by experimenters and seated at separate tables. After completeing a set of motivatioal ratings they were presented with the first set of 15 sensory stimuli for taste and hedonic evaluations.

0930 h- given breakfast which consisted of 500 g of white cheese. Asked to rate breakfast sweetness, fat content, and acceptability using 9-point category scales.

A second set of motivational ratings was obtained at 1000 and every 30 min thereafter until 1200. at that time subjects were presented with the same 15 sensory stimuli for a second set of evaluations.

1230 h- lunch was served for 30 minutes and then completed another set of motivational ratings.

1600 h-snack was served and another set of motivational ratings before the snack.

1900 h- following another set of motivational ratings the subjects ate the evening meal and left the laboratory at 1930 h. Subjects remained in the laboratory during the day.

Description of Actual Data Sample:

Initial N: 12 0bese and 12 lean women

Summary of subject characteristics Mean and( SD)
	Obese (n=12)	Lean (n=12)
Age (yrs)	34.4(7.6)	24.9 (2.7)
Height (cm)	163.0(6.4)	167.2 (6.4)
Weight (kg)	110.5 (17.9)	59.2 (6.7)
BMI (kg/m²)	41.1 (6.2)	21.1 (1.8)
Restraint Score	15.9 (4.2)	7.9(3.1)

Location: Paris France

Summary of Results:

Motivational and Taste Preference ratings

Averaged for obese and lean women, all four preloads, regardless of sweetness and energy content had similar effects on hunger ratings during the first 30-60 minutes post-ingestion. However, higher hunger ratings were obtained after low-energy preloads C(aspartame) and D(plain) than after the sucrose-sweetened Preload A.
Taste preferences were not affected by preload ingestion or by preload type.

Energy Intakes-

Obese women consumed significantly more energy at meals (2596 kcal or 10,862 kJ) than did lean women (1484 kcal or 6,209 kJ); derived a greater proportion of energy from fat (39.9% vs. 35.5 %) and had lower dietary carbohydrate to fat ratios. Energy intakes at lunch, snack or dinner did not vary as a function of preload type, and no compensation was observed for the energy consumed at breakfast.

Daily energy intakes (kcal and kJ) excluding breakfast preloads as a function of overweight and preload type. the data re measns and SD's in (parentheses)
preload		A	B	C	D
Obese (n=12)	kcal	2745 (551)	2535 (791)	2505 (773)	2602 (504)
	KJ	11485(2305)	10606(3310)	10477(3234)	10887 (2109)
Lean (n=12)	kcal	1529( 512)	1357 (269)	1445 (408)	1604 (463)
	kJ	6397(2142)	5678 (1125)	6046 (1707)	6711 (1937)

Author Conclusion:

The study provided no evidence that aspartame promotes hunger or results in increased energy intakes in obese or in lean women.

Funding Source:

Government:	INSERM
University/Hospital:	University of Michigan, University of Paris, Faculte de Medicine Xavier Bichat

Reviewer Comments:

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?		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)	Yes
	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?	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%.)	N/A
	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?		No
	5.1.	In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate?	???
	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.)	???
	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?	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
	7.1.	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)?	N/A
	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?	N/A
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?	No
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