Appetite Hormones in Binge Eating Disorder

New York Obesity and Nutrition Research Center

Status: Completed

Conditions: Binge Eating Disorder

Treatments: Behavioral: Test meal; Procedure: Postprandial responses; Behavioral: Cold pressor test

Study type: Interventional

Funder types: Other

Identifiers

NCT01552759

06-163

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 3 patient groups

Obese subjects with BED

Experimental group

Description:

Subjects who meet the BMI requirement for obesity (\>30 kg/m\^2) and the DSM requirements for binge eating disorder based on responses to validated questionnaires. Subjects will undergo the postprandial responses, cold pressor test and ad libitum test meal.

Treatment:

Procedure: Postprandial responses

Behavioral: Cold pressor test

Behavioral: Test meal

Obese without BED

Experimental group

Description:

Subjects who meet the BMI requirement for obesity (\>30 kg/m\^2) but who do not meet the DSM requirements for binge eating disorder based on responses to validated questionnaires. Subjects will undergo the postprandial responses, cold pressor test and ad libitum test meal.

Treatment:

Procedure: Postprandial responses

Behavioral: Cold pressor test

Behavioral: Test meal

Normal-weight without BED

Experimental group

Description:

Subjects with BMI 20-25 kg/m\^2 who do not meet the DSM requirements for binge eating disorder based on responses to validated questionnaires. Subjects will undergo the postprandial responses, cold pressor test and ad libitum test meal.

Treatment:

Procedure: Postprandial responses

Behavioral: Cold pressor test

Behavioral: Test meal