Cognitive Function and Cue-Reactivity Study

June 28, 2013 updated by: Temple University

Cognitive Performance and Food Reactivity During High and Low Carbohydrate Obesity Treatment

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.

Study Overview

Status

Completed

Conditions

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 (e.g., 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 (i.e., 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 (e.g., 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 order.Participants 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 participant's 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 participant.5-minute psychophysiologic data (i.e., 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 taken.Participants will remove the dental rolls and place them in a plastic zip-lock bag.The 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 Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19140
    - Temple University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

all participants who took part in the Safety and Efficacy of Low and High Carbohydrate Diets study

Description

Inclusion Criteria:

Body mass index between 30 and 40
Live and work within 1 hour of the study site
Stable psychological status

Exclusion Criteria:

History of heart disease, heart attack, or stroke
Blood pressure > 140/90 mmHG
Abnormal cholesterol levels
Significant psychiatric illness
Any medication that affects weight or metabolic rate
Presence or history of a chronic disease that is known to affect appetite, food intake, or metabolism (i.e. diabetes, thyroid disease or cancer).
Currently using antidepressants, steroids, tobacco or illegal drugs
Pregnant, breastfeeding, or planning pregnancy
10 lb change in weight within 6 months of study entry
History of malignant arrhythmias or cerebrovascular, renal, or hepatic disease
History of protein wasting diseases or gout
Severe arthritis
Osteoporosis
Certain types of hormone replacement therapy
Currently following a vegetarian diet

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the relationships between cognitive and physiological reactivity to food and non-food cues Time Frame: 2 year period	2 year period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Temple University

Collaborators

National Institutes of Health (NIH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2003

Primary Completion (ACTUAL)

March 1, 2010

Study Completion (ACTUAL)

March 1, 2010

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria