ClinicalTrials.gov
ClinicalTrials.gov Menu

Cephalic Phase in Anorexia Nervosa,Bulimia Nervosa and Obese Binge Eaters (Cephalic 1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00493519
Recruitment Status : Unknown
Verified April 2007 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Recruiting
First Posted : June 28, 2007
Last Update Posted : July 6, 2007
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The objective of this trial is to examine the cephalic phase insulin response (CPIR) and pancreatic polypeptide (PP) release as indicators of the cephalic phase occurrence and magnitude to palatable food stimulus in anorectic and bulimic subgroups as compared to healthy controls

Condition or disease Intervention/treatment Phase
Anorexia Nervosa Bulimia Nervosa Procedure: chocolate cake Not Applicable

Detailed Description:

Food stimulation of gastric and pancreatic secretion is classically divided into cephalic, gastric and intestinal phases.

Cephalic phase refers to a simultaneous activation of gastrointestinal motility, gastric acid and pancreatic enzyme secretion ,as well as, release of hormones from the endocrine pancreas which occurs through activation of vagal -efferents as a result of food-related sensory stimuli such as taste and smell prior to nutrient absorption and which coincides with a thermogenic response.

Of the cephalic phase secretions, cephalic phase insulin release (CPIR) has received the most attention, but pancreatic polypeptide (PP) and glucagon responses have also been studied. While the magnitude of cephalic phase insulin release is relatively small (25% above baseline), pancreatic polypeptide increases 100% above baseline. The large magnitude of the PP response makes it a sensitive indicator of vagal activation to food stimuli.

In most experiments, subjects are either exposed to visual and olfactory stimulation by seeing and smelling the food stimulus or are required to perform a modified sham-feed, i.e. to taste, chew and then expectorate the food stimulus.

In general, cephalic phase are thought to be preparatory response before ingestion of food. Because of their small magnitude, the physiological significance of the cephalic phase hormonal responses has been largely discounted. However, there is evidence that experimental prevention of CPIR lead to hyperinsulinemia and hyperglycemia. Therefore, CPIR may contribute to glucose homeostasis /regulation. Moreover CPIR may be an indicator of hunger and could be important for understanding eating disorders.

In parallel with these hormonal secretion ,an increase in energy expenditure has also been observed . This thermogenic response to food is even greater with sham feeding than with normal feeding and is paralleled by changes in RQ showing enhanced carbohydrate oxidation.

Studies conducted in obese humans demonstrate exaggerated absolute magnitude of CPIR .However basal hyper-insulinemia which is typically observed in obese individuals may clouds this observation. Moreover, it has been hypothesized that CPIR is attenuated in obese when is expressed as a percentage of baseline and therefore they may not secrete enough insulin during pre-absorptive period to regulate postprandial glucose levels.

There is also evidence that obese people with insulin resistance have a reduced thermogenic response to feeding .

Only limited numbers of studies have been done on the cephalic phase in anorexia and bulimia. There are findings of a significant CPIR in anorexics as compared to controls which tends to rule out a deficient cephalic insulin response as a contributor to the self-starvation observed in anorexia nervosa. As to bulimics who often show endocrine abnormalities, their CPIR was only slightly differ or from controls.

These findings suggest more complex determinants of eating disorders than physiological state alone.


Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Cephalic Phase in Anorexia Nervosa,Bulimia Nervosa and Obese Binge Eaters
Study Start Date : July 2007
Estimated Study Completion Date : December 2007

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. VAS, EDI, Blood test for glucose, insulin, PP, shame feed procedure [ Time Frame: 1 year ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

75 patients will be divided into the following 4 subgroups;

  1. . 15 patients with anorexia nervosa.
  2. . 15 patients with bulimia nervosa (purging type).
  3. . 15 patients with binge eating disorder and obesity.
  4. . 15 obese patients without eating disorder
  5. . 15 Non-eating disordered normal weight patients.

Non diabetic and non-pregnant patients above 18 years of age without gastrointestinal diseases and without medications which can affect gastrointestinal motility and appetite.

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00493519


Contacts
Contact: Nachum Vaisman, Prof. +972-524-266596 vaisman@tasmc.health.gov.il

Locations
Israel
TASMC Recruiting
Tel Aviv, Israel, 64239
Contact: Nachum Vaisman, Prof.    +972-524-266596    vaisman@tasmc.health.gov.il   
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Nachum Vaisman, Prof. TASMC Israel
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00493519     History of Changes
Other Study ID Numbers: TASMC-07-NV-219-CTIL
First Posted: June 28, 2007    Key Record Dates
Last Update Posted: July 6, 2007
Last Verified: April 2007

Keywords provided by Tel-Aviv Sourasky Medical Center:
Cephalic phase
Anorexia nervosa
Bulimia nervosa
obese binge eaters
 VAS
EDI
shame-feed procedure

Additional relevant MeSH terms:
Anorexia
Anorexia Nervosa
Bulimia
Bulimia Nervosa
Signs and Symptoms, Digestive
 Signs and Symptoms
Feeding and Eating Disorders
Mental Disorders
Hyperphagia