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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03356509
Other study ID # 20170895
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 8, 2018
Est. completion date September 15, 2018

Study information

Verified date September 2018
Source University of Miami
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study will use stress inducing tasks to determine if there are significant improvements in mood, chocolate cravings, and attentional bias to chocolate in overweight/obese chocolate abusers following rest and a bout of high intensity interval exercise.


Description:

The purpose of this research study is to investigate whether a single high intensity interval exercise (HIIE) bout, following two stress-inducing tasks, reduces addictive behavior to chocolate. Volunteers must complete the consent form before being able to participate in two days of testing (exercise day and control day) which will be presented in randomized order. The two days will be separated by a one to 7 day washout period. Subjects will be required to submit a three day chocolate diary then abstain from chocolate on the 4th day. They will also be asked to record everything they eat and drink on the day before and the morning of the study and list three types of chocolate they crave most. Two stress-inducing tasks will be performed on both days followed by completion of either 26 minutes of HIIE or seated resting condition followed by the completion of two mood and craving questionnaires. They will finally be asked to complete a task that measures the amount of attention they pay to chocolate. Statistical analyses will be conducted to determine the effect of either exercising or not on addictive behaviors to chocolate.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date September 15, 2018
Est. primary completion date September 15, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- BMI equal or greater than 25

- Eat at least 3.5 oz of chocolate per day

- Scorer at least 33 out of a possible 36 on the Handedness Questionnaire

- Ability to provide informed consent

- No medical contraindications to exercise

- Premenopausal

Exclusion Criteria:

- PMS

- Pregnancy

- Prisoners

- Risk factors for heart disease as determined by physician

- Medication that interferes with capacity to exercise

- Answer "Yes" to PAR-Q

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Exercise
Exercise will be performed on a stationary bicycle ergometer.

Locations

Country Name City State
United States Laboratory of Clinical and Applied Physiology Coral Gables Florida

Sponsors (1)

Lead Sponsor Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Attentional Bias (AB) to chocolate using a modified visual dot probe task (Kemps et al, 2009) AB will be measured using a modified visual dot probe task, which consists of measuring reaction times to neutral images versus chocolate images (Kemps et al, 2009). Neutral images will consist of non-chocolate related items (i.e. office supplies). After 5 practice trials, 60 critical trials will be displayed which consist of either chocolate or neutral images (presented side by side). A black fixation cross will appear behind one of the images, and the subject has to respond as quickly as possible to which image the cross is located behind. The faster the subject responds to the cross behind the chocolate image, the higher their attentional bias is to chocolate. AB will be measured on both days following both the exercise and control conditions. 15 minutes
Secondary Affective Valence measured by The Feeling Scale (Hardy & Rejeski, 1989) The Feeling Scale measures affective valence using an 11 point range from -5 to +5 with higher values indicating more pleasure. It is administered on both days following both the exercise and the control condition. 1 minute
Secondary Affective Activation measured by the Felt Arousal Scale (Svebak & Murgatroyd, 1985) The Felt Arousal Scale measures affective activation using a 6 point range from 1 to 6 with the higher values indicating greater activation and arousal. It is administered on both days following both the exercise and the control condition. 1 minute
Secondary Cravings for chocolate using the State Food Cravings Questionnaire (Cepeda-Benito et al, 2000) This questionnaire measures the acute intensity of chocolate cravings using 15 items with 3 items per dimension. The five state dimensions of food cravings are: an intense desire to consume food, anticipation of positive reinforcement from eating, anticipation of relief from negative states and feelings as a result of eating, lack of control over eating if food is eaten, and craving as a hunger/physiological state. The dimensions will be evaluated using a 5 point Likert scale with the higher score meaning more intense cravings for chocolate. The questionnaire will be administered on both days following both the exercise and the control condition. 5 minutes