Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00194246
Status:
COMPLETED
Last Update Posted:
2013-07-01
First Post:
2005-09-13
Brief Title:
Cognitive Function and Cue-Reactivity Study
Sponsor:
Temple University
Organization:
Temple University
Study Overview
Official Title:
Cognitive Performance and Food Reactivity During High and Low Carbohydrate Obesity Treatment
Status:
COMPLETED
Status Verified Date:
2007-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
We are interested in testing differences in cognitive function and food reactivity at various time points in individuals following low and high carbohydrate diets We wish to achieve an understanding of these time-specific differences using repeated measures analysis of variance ANOVA with diet condition low vs high carbohydrate as a between subject factor and time as a within-subject factor
Detailed Description:
Participants will be recruited from the parent study The Safety and Efficacy of Low and High Carbohydrate Diets Participants will attend one 30-minute training session to learn the computer tasks and rate food desirability Participants will rate their desire to eat 24 foods on a 9-point Likert scale eg 1 do not desire at all 5 neutral neither desire nor not desire 9 desire extremely These ratings will be used to establish emotionally salient and neutral cues for the computerized tests ie Cue Reactivity and Stroop test used during the study
Each individual will participate on separate occasions in one 45-60 minute testing session before onset of treatment week 0 and four 45-60 minute testing sessions that coincide with treatment assessments in the approved study weeks 12 26 54 Testing will be conducted one and a half hours following consumption of a standard snack to ensure that all participants are in the same metabolic state Participants will complete three consecutive computerized tests in the following order 1 Continual Performance Test CPT 2 Stroop test 3 Cue Reactivity Test Based on a previous study showing impairments in cognitive function one week after initiation of a low carbohydrate diet participants will also complete a 5-minute cognitive task eg Continual Performance Task one and four weeks after modifications in eating have begun On these weeks participants will be given a small snack prior to the group meeting Testing will occur at the conclusion of weekly group meetings ensuring that participants have abstained from food for approximately one and half hours
The 15 minute cue reactivity test consists of three cue trials that vary only in terms of the cue presented one neutral non-food cue one neutral food cue and one emotionally salient food cue The order of these trials will be presented in a counter-balanced orderParticipants will complete a VAS questionnaire rating their feelings of hunger craving and anxiety Participants will insert dental rolls prior to each of three five-minute cue-presentation trials While participants insert the dental rolls the experimenter will place the relevant cue on a platter This platter will have a divider barrier attached to it that obstructs the cue from the participants view while the experimenter is in the room After the rolls are inserted and the cue is placed on the platter the experimenter will leave the room and rotate the platter via remote control until the cue is in clear view of the participant5-minute psychophysiologic data ie heart rate skin conductance acquisition will begin as the platter is being rotated Participants will be instructed via audiotape to focus their attention on the cue imagine picking it up smelling it and tasting it etc At the end of this 5-minute interval blood pressure measures will be takenParticipants will remove the dental rolls and place them in a plastic zip-lock bagThe experimenter will return to the room and ask the participant to complete the post-trial VAS questionnaire rating their feelings of hunger craving and anxiety Then participants will be provided with one ounce of water
Each individual will participate on separate occasions in one 45-60 minute testing session before onset of treatment week 0 and four 45-60 minute testing sessions that coincide with treatment assessments in the approved study weeks 12 26 54 Testing will be conducted one and a half hours following consumption of a standard snack to ensure that all participants are in the same metabolic state Participants will complete three consecutive computerized tests in the following order 1 Continual Performance Test CPT 2 Stroop test 3 Cue Reactivity Test Based on a previous study showing impairments in cognitive function one week after initiation of a low carbohydrate diet participants will also complete a 5-minute cognitive task eg Continual Performance Task one and four weeks after modifications in eating have begun On these weeks participants will be given a small snack prior to the group meeting Testing will occur at the conclusion of weekly group meetings ensuring that participants have abstained from food for approximately one and half hours
The 15 minute cue reactivity test consists of three cue trials that vary only in terms of the cue presented one neutral non-food cue one neutral food cue and one emotionally salient food cue The order of these trials will be presented in a counter-balanced orderParticipants will complete a VAS questionnaire rating their feelings of hunger craving and anxiety Participants will insert dental rolls prior to each of three five-minute cue-presentation trials While participants insert the dental rolls the experimenter will place the relevant cue on a platter This platter will have a divider barrier attached to it that obstructs the cue from the participants view while the experimenter is in the room After the rolls are inserted and the cue is placed on the platter the experimenter will leave the room and rotate the platter via remote control until the cue is in clear view of the participant5-minute psychophysiologic data ie heart rate skin conductance acquisition will begin as the platter is being rotated Participants will be instructed via audiotape to focus their attention on the cue imagine picking it up smelling it and tasting it etc At the end of this 5-minute interval blood pressure measures will be takenParticipants will remove the dental rolls and place them in a plastic zip-lock bagThe experimenter will return to the room and ask the participant to complete the post-trial VAS questionnaire rating their feelings of hunger craving and anxiety Then participants will be provided with one ounce of water
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None