Appetite Hormones in Binge Eating Disorder

This study has been completed.
Sponsor:
Collaborators:
St. Luke's-Roosevelt Hospital Center
Columbia University
Information provided by (Responsible Party):
Dr. Allan Geliebter, New York Obesity and Nutrition Research Center
ClinicalTrials.gov Identifier:
NCT01552759
First received: March 9, 2012
Last updated: March 8, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Binge Eating Disorder
Procedure: Postprandial responses
Behavioral: Cold pressor test
Behavioral: Test meal

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Appetite Hormones in Binge Eating Disorder

Resource links provided by NLM:


Further study details as provided by New York Obesity and Nutrition Research Center:

Primary Outcome Measures:
  • Appetite-related Hormones and Appetite Ratings in Relation to Fixed Meal and Cold Pressor Test [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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:
  • Cortisol Awakening response [ Time Frame: Assessed on one weekday morning during the 3-week participation period ] [ Designated as safety issue: No ]
    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 [ Time Frame: During one initial consultation and on two subsequent visits at least 1 week apart ] [ Designated as safety issue: No ]
    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 [ Time Frame: During one initial consultation and on two subsequent visits at least 1 week apart ] [ Designated as safety issue: No ]
    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.


Enrollment: 96
Study Start Date: May 2007
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Obese subjects with BED

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.

Procedure: Postprandial responses
Subjects ingest a fixed meal, with blood draws to measure appetite hormone levels taken before and after the meal.
Other Name: Liquid meal replacement is Boost (Nestle Nutrition).
Behavioral: Cold pressor test
Subjects then undergo the Socially-Evaluated Cold Pressor Test, with blood draws to measure appetite hormone levels taken before and after the test.
Behavioral: Test meal
Subjects are presented with an ad libitum buffet meal.
Experimental: Obese without BED

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.

Procedure: Postprandial responses
Subjects ingest a fixed meal, with blood draws to measure appetite hormone levels taken before and after the meal.
Other Name: Liquid meal replacement is Boost (Nestle Nutrition).
Behavioral: Cold pressor test
Subjects then undergo the Socially-Evaluated Cold Pressor Test, with blood draws to measure appetite hormone levels taken before and after the test.
Behavioral: Test meal
Subjects are presented with an ad libitum buffet meal.
Experimental: Normal-weight without BED

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.

Procedure: Postprandial responses
Subjects ingest a fixed meal, with blood draws to measure appetite hormone levels taken before and after the meal.
Other Name: Liquid meal replacement is Boost (Nestle Nutrition).
Behavioral: Cold pressor test
Subjects then undergo the Socially-Evaluated Cold Pressor Test, with blood draws to measure appetite hormone levels taken before and after the test.
Behavioral: Test meal
Subjects are presented with an ad libitum buffet meal.

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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01552759

Locations
United States, New York
St. Luke's Hospital
New York, New York, United States, 10025
Sponsors and Collaborators
New York Obesity and Nutrition Research Center
St. Luke's-Roosevelt Hospital Center
Columbia University
Investigators
Principal Investigator: Allan Geliebter, PhD New York Obesity and Nutrition Research Center
  More Information

Additional Information:
Publications:

Responsible Party: Dr. Allan Geliebter, Principal Investigator, New York Obesity and Nutrition Research Center
ClinicalTrials.gov Identifier: NCT01552759     History of Changes
Other Study ID Numbers: 06-163
Study First Received: March 9, 2012
Last Updated: March 8, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by New York Obesity and Nutrition Research Center:
Appetite Hormones
Binge Eating Disorder
Obesity
Cortisol
Stress

Additional relevant MeSH terms:
Bulimia
Binge-Eating Disorder
Eating Disorders
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms
Mental Disorders
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014