Clinical trial NCT01552759: Appetite Hormones in Binge Eating Disorder
Official title: Appetite Hormones in Binge Eating Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Binge Eating Disorder
Keywords: Appetite Hormones
Binge Eating Disorder
Obesity
Cortisol
Stress
Lead sponsor: New York Obesity and Nutrition Research Center
Sponsor class: OTHER
Collaborators: name: St. Luke's-Roosevelt Hospital Center
name: Columbia University
First posted: 2012-03-13
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study investigates the hormones that the body produces in response to food intake and in response to stress, and the way that stress influences food intake. In particular, it compares the hormone levels and food intake of people with and without binge eating disorder. In order to find out how these appetite- and stress-related hormones are linked to brain activity, the study also includes an fMRI scan, a non-invasive procedure that looks at which regions of the brain are most active during a food-related scenario.

Detailed description: The objectives are to study appetite-related hormones regulating food intake under normal conditions and following a stressor in the morning and evening (when most binge episodes occur), to help reveal biological mechanisms in BED. We plan to enroll: 32 obese Ss with BED (16m, 16f), 32 obese Ss without BED (16m, 16f) and 32 normal-weight Ss without BED (16m, 16f). Height, weight, waist circumference, and body fat will be assessed during a first appointment. On two different days separated by at least a week, Ss will ingest a fixed liquid meal once in the morning and once in the evening. Appetite ratings and collections of blood and saliva to measure hormones will continue for 2 hours after the fixed meal. This will be followed on each day by a laboratory stress protocol (Socially Evaluated Cold Pressor Test; SECPT), and then consumption of an ad libitum meal 30 minutes later. On one day during the protocol, the participant will collect saliva using a swab immediately after waking and again at 08.00. In order to capture more naturalistic eating episodes, all Ss will additionally record food intake, rate appetite, and measure salivary cortisol before and after one evening meal, and one after-dinner snack (or after-dinner binge for BED Ss). On two additional days, we will use fMRI to assess brain activation in response to high-palatability food (HPF) relative to low-palatability food (LPF) or non-food (NF) visual cues following the SECPT and a control condition using warm water. On each day, following the fMRI scan, an ad libitum meal will be consumed.

Eligibility criteria: Inclusion Criteria:

* BMI of 20-25 or 30-50
* stable weight(± 4%) for at least 3 mo
* premenopausal and have regular menstrual cycles (28 d ± 5), not be pregnant or lactating, and not be within 1 y of childbirth
* must like pizza and be willing to consume it during the ad libitum meal

Exclusion Criteria:

* significant medical or psychiatric conditions
* current and past 3-mo use of certain prescribed medications, especially those that could affect body weight, such as antidepressants and stimulants as well as smoking, or excess alcohol (\> 3 drinks/d)
* vigorously exercise for more than 6 h/wk
* left-handed, with known claustrophobia for a scanner enclosure, or have metal implants, non-removable metallic dental retainers, pacemakers, or permanent eyeliner or large tattoos that contain metallic pigment

Primary outcomes:
measure: Appetite-related Hormones and Appetite Ratings in Relation to Fixed Meal and Cold Pressor Test
timeFrame: Assessed at systematic intervals (-15, 0, 10, 30, 60, 90, 120 min) before and after the morning fixed meal at 10.00 and the evening fixed meal at 17.00
Secondary outcomes:
measure: Cortisol Awakening response
timeFrame: Assessed on one weekday morning during the 3-week participation period
measure: Psychological Scales
timeFrame: During one initial consultation and on two subsequent visits at least 1 week apart
measure: Body Weight, Body Composition and Gender
timeFrame: During one initial consultation and on two subsequent visits at least 1 week apart
Other outcomes:
Locations:
city: New York
country: United States
facility: St. Luke's Hospital
state: New York
Study officials:
affiliation: New York Obesity and Nutrition Research Center
name: Allan Geliebter, PhD
role: PRINCIPAL_INVESTIGATOR
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