Appetite Hormones in Binge Eating Disorder
- Conditions
- Binge Eating Disorder
- Interventions
- Procedure: Postprandial responsesBehavioral: Cold pressor testBehavioral: Test meal
- Registration Number
- NCT01552759
- Lead Sponsor
- New York Obesity and Nutrition Research Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 96
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Obese subjects with BED Postprandial responses 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. Obese subjects with BED Cold pressor test 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. Obese subjects with BED Test meal 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. Obese without BED Postprandial responses 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. Obese without BED Cold pressor test 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. Obese without BED Test meal 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. Normal-weight without BED Postprandial responses 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. Normal-weight without BED Cold pressor test 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. Normal-weight without BED Test meal 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.
- Primary Outcome Measures
Name Time Method Appetite-related Hormones and Appetite Ratings in Relation to Fixed Meal and Cold Pressor Test 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 Blood and saliva concentrations of hormones influencing appetite will be measured 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. Appetite will additionally be rated at each assessment point. This will be followed by a cold pressor test, and then 30 min later by an ad libitum meal 30 min later, with blood and saliva measurements taken before and after completion of the meal.
- Secondary Outcome Measures
Name Time Method Cortisol Awakening response Assessed on one weekday morning during the 3-week participation period On one weekday morning during the 3-week participation period, participants will take one saliva measurement on awakening and at 08.00 while still fasting. Awakening and 08.00 cortisol levels are expected to be higher in BED compared with nonBED Ss, and in obese nonBED compared with normal-weight nonBED Ss.
Psychological Scales During one initial consultation and on two subsequent visits at least 1 week apart Various questionnaires will be administered to test relationships between outcomes (e.g., intake, hormone levels), and psychological constructs including depression, perceived stress, external and emotional eating and restraint, binge-eating behavior, and night eating. Outcomes will be correlated with scale scores, and scores will be compared between groups. Among other relationships, we anticipate positive correlations between binge eating score, ad libitum intake and ghrelin SECPT response. Psychological scores will be entered as covariates as appropriate.
Body Weight, Body Composition and Gender During one initial consultation and on two subsequent visits at least 1 week apart Measurements will include height, weight, waist circumference, total body fat from BIA, and cross-sectional abdominal MRI to estimate central, visceral, and subcutaneous fat. Each adiposity index will be correlated with outcomes and compared between groups.
Trial Locations
- Locations (1)
St. Luke's Hospital
🇺🇸New York, New York, United States