Appetite Hormones in Binge Eating Disorder

NCT01552759 | Completed DMC

• 1 other identifier: 06-163
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Binge Eating Disorder

Keywords

Appetite Hormones; Binge Eating Disorder; Obesity; Cortisol; Stress

Outcome Measures

Primary Outcomes (1)

• Appetite-related Hormones and Appetite Ratings in Relation to Fixed Meal and Cold Pressor Test

  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.

  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 (3)

• Cortisol Awakening response

  Assessed on one weekday morning during the 3-week participation period

• Psychological Scales

  During one initial consultation and on two subsequent visits at least 1 week apart

• Body Weight, Body Composition and Gender

  During one initial consultation and on two subsequent visits at least 1 week apart

Study Arms (3)

Obese subjects with BED

EXPERIMENTAL

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; Behavioral: Cold pressor test; Behavioral: Test meal

Obese without BED

EXPERIMENTAL

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; Behavioral: Cold pressor test; Behavioral: Test meal

Normal-weight without BED

EXPERIMENTAL

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; Behavioral: Cold pressor test; Behavioral: Test meal

Interventions

Postprandial responses PROCEDURE

Subjects ingest a fixed meal, with blood draws to measure appetite hormone levels taken before and after the meal.

Also known as: Liquid meal replacement is Boost (Nestle Nutrition).

Normal-weight without BED; Obese subjects with BED; Obese without BED

Cold pressor test BEHAVIORAL

Subjects then undergo the Socially-Evaluated Cold Pressor Test, with blood draws to measure appetite hormone levels taken before and after the test.

Normal-weight without BED; Obese subjects with BED; Obese without BED

Test meal BEHAVIORAL

Subjects are presented with an ad libitum buffet meal.

Normal-weight without BED; Obese subjects with BED; Obese without BED

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• New York Obesity and Nutrition Research Center: lead
• St. Luke's-Roosevelt Hospital Center: collaborator
• Columbia University: collaborator

Study Sites (1)

St. Luke's Hospital

New York, New York, 10025, United States

Location

Related Publications (22)

• de Zwaan M, Mitchell JE, Raymond NC, Spitzer RL. Binge eating disorder: clinical features and treatment of a new diagnosis. Harv Rev Psychiatry. 1994 Mar-Apr;1(6):310-25. doi: 10.3109/10673229409017098.

  PMID: 9384866 BACKGROUND

• Hellstrom PM, Geliebter A, Naslund E, Schmidt PT, Yahav EK, Hashim SA, Yeomans MR. Peripheral and central signals in the control of eating in normal, obese and binge-eating human subjects. Br J Nutr. 2004 Aug;92 Suppl 1:S47-57. doi: 10.1079/bjn20041142.

  PMID: 15384323 BACKGROUND

• Cowley MA, Smith RG, Diano S, Tschop M, Pronchuk N, Grove KL, Strasburger CJ, Bidlingmaier M, Esterman M, Heiman ML, Garcia-Segura LM, Nillni EA, Mendez P, Low MJ, Sotonyi P, Friedman JM, Liu H, Pinto S, Colmers WF, Cone RD, Horvath TL. The distribution and mechanism of action of ghrelin in the CNS demonstrates a novel hypothalamic circuit regulating energy homeostasis. Neuron. 2003 Feb 20;37(4):649-61. doi: 10.1016/s0896-6273(03)00063-1.

  PMID: 12597862 BACKGROUND

• Batterham RL, Cohen MA, Ellis SM, Le Roux CW, Withers DJ, Frost GS, Ghatei MA, Bloom SR. Inhibition of food intake in obese subjects by peptide YY3-36. N Engl J Med. 2003 Sep 4;349(10):941-8. doi: 10.1056/NEJMoa030204.

  PMID: 12954742 BACKGROUND

• English PJ, Ghatei MA, Malik IA, Bloom SR, Wilding JP. Food fails to suppress ghrelin levels in obese humans. J Clin Endocrinol Metab. 2002 Jun;87(6):2984. doi: 10.1210/jcem.87.6.8738.

  PMID: 12050284 BACKGROUND

• Monteleone P, Martiadis V, Rigamonti AE, Fabrazzo M, Giordani C, Muller EE, Maj M. Investigation of peptide YY and ghrelin responses to a test meal in bulimia nervosa. Biol Psychiatry. 2005 Apr 15;57(8):926-31. doi: 10.1016/j.biopsych.2005.01.004.

  PMID: 15820714 BACKGROUND

• Monteleone P, Martiadis V, Fabrazzo M, Serritella C, Maj M. Ghrelin and leptin responses to food ingestion in bulimia nervosa: implications for binge-eating and compensatory behaviours. Psychol Med. 2003 Nov;33(8):1387-94. doi: 10.1017/s0033291703008316.

  PMID: 14672247 BACKGROUND

• Geliebter A, Yahav EK, Gluck ME, Hashim SA. Gastric capacity, test meal intake, and appetitive hormones in binge eating disorder. Physiol Behav. 2004 Jul;81(5):735-40. doi: 10.1016/j.physbeh.2004.04.014.

  PMID: 15234178 BACKGROUND

• Geliebter A, Gluck ME, Hashim SA. Plasma ghrelin concentrations are lower in binge-eating disorder. J Nutr. 2005 May;135(5):1326-30. doi: 10.1093/jn/135.5.1326.

  PMID: 15867334 BACKGROUND

• Raymond NC, Neumeyer B, Warren CS, Lee SS, Peterson CB. Energy intake patterns in obese women with binge eating disorder. Obes Res. 2003 Jul;11(7):869-79. doi: 10.1038/oby.2003.120.

  PMID: 12855757 BACKGROUND

• Walsh BT, Boudreau G. Laboratory studies of binge eating disorder. Int J Eat Disord. 2003;34 Suppl:S30-8. doi: 10.1002/eat.10203.

  PMID: 12900984 BACKGROUND

• Anderson DA, Williamson DA, Johnson WG, Grieve CO. Validity of test meals for determining binge eating. Eat Behav. 2001 Summer;2(2):105-12. doi: 10.1016/s1471-0153(01)00022-8.

  PMID: 15001040 BACKGROUND

• Geliebter A, Melton PM, McCray RS, Gallagher DR, Gage D, Hashim SA. Gastric capacity, gastric emptying, and test-meal intake in normal and bulimic women. Am J Clin Nutr. 1992 Oct;56(4):656-61. doi: 10.1093/ajcn/56.4.656.

  PMID: 1414964 BACKGROUND

• Geliebter A, Hassid G, Hashim SA. Test meal intake in obese binge eaters in relation to mood and gender. Int J Eat Disord. 2001 May;29(4):488-94. doi: 10.1002/eat.1047.

  PMID: 11285588 BACKGROUND

• Tataranni PA, Larson DE, Snitker S, Young JB, Flatt JP, Ravussin E. Effects of glucocorticoids on energy metabolism and food intake in humans. Am J Physiol. 1996 Aug;271(2 Pt 1):E317-25. doi: 10.1152/ajpendo.1996.271.2.E317.

  PMID: 8770026 BACKGROUND

• Castonguay TW. Glucocorticoids as modulators in the control of feeding. Brain Res Bull. 1991 Sep-Oct;27(3-4):423-8. doi: 10.1016/0361-9230(91)90136-8.

  PMID: 1959040 BACKGROUND

• Epel E, Lapidus R, McEwen B, Brownell K. Stress may add bite to appetite in women: a laboratory study of stress-induced cortisol and eating behavior. Psychoneuroendocrinology. 2001 Jan;26(1):37-49. doi: 10.1016/s0306-4530(00)00035-4.

  PMID: 11070333 BACKGROUND

• Koo-Loeb JH, Costello N, Light KC, Girdler SS. Women with eating disorder tendencies display altered cardiovascular, neuroendocrine, and psychosocial profiles. Psychosom Med. 2000 Jul-Aug;62(4):539-48. doi: 10.1097/00006842-200007000-00013.

  PMID: 10949100 BACKGROUND

• Kelly CB, Cooper SJ. Plasma norepinephrine response to a cold pressor test in subtypes of depressive illness. Psychiatry Res. 1998 Oct 19;81(1):39-50. doi: 10.1016/s0165-1781(98)00086-9.

  PMID: 9829649 BACKGROUND

• Gluck ME, Geliebter A, Hung J, Yahav E. Cortisol, hunger, and desire to binge eat following a cold stress test in obese women with binge eating disorder. Psychosom Med. 2004 Nov-Dec;66(6):876-81. doi: 10.1097/01.psy.0000143637.63508.47.

  PMID: 15564352 BACKGROUND

• Yanovski SZ. Binge eating disorder: current knowledge and future directions. Obes Res. 1993 Jul;1(4):306-24. doi: 10.1002/j.1550-8528.1993.tb00626.x.

  PMID: 16350580 BACKGROUND

• Geliebter A, Ladell T, Logan M, Schneider T, Sharafi M, Hirsch J. Responsivity to food stimuli in obese and lean binge eaters using functional MRI. Appetite. 2006 Jan;46(1):31-5. doi: 10.1016/j.appet.2005.09.002. Epub 2005 Dec 20.

  PMID: 16364498 BACKGROUND

Related Links

• New York Obesity and Nutrition Research Center

MeSH Terms

Conditions

Binge-Eating Disorder; Obesity

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Allan Geliebter, PhD

  New York Obesity and Nutrition Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 9, 2012
• First Posted: March 13, 2012
• Study Start: May 1, 2007
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: March 11, 2013

Record last verified: 2013-03

Locations

US (1)