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Taste Study: A Study of the Function of Hormones Present in Taste Buds

This study is currently recruiting participants.
Study NCT00233298.   Last updated on August 19, 2008.   Information provided by National Institute on Aging (NIA)

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Descriptive Information Fields
Brief Title  Taste Study: A Study of the Function of Hormones Present in Taste Buds
Official Title  A Study of the Function of Hormones Present in Taste Buds
Brief Summary

The purpose of this study is to find out whether the hormones in the taste buds are affected by tasting and eating food, and also whether these hormone levels are affected by an increase in body weight or type 2 diabetes.

Detailed Description

This study is being done to determine whether hormones will be secreted by the taste cells located in the taste buds in response to tasting food. The study will compare responses of these hormones in participants who are healthy and normal weight, healthy and overweight, or have pre-diabetes or type 2 diabetes and overweight.

Interested individuals will be scheduled for a screening visit, for which they will have to fast for at least 8 hours overnight. This visit will include medical history, physical examination, laboratory tests, and a 75-gram oral glucose tolerance test (OGTT).

Participants who meet the inclusion criteria will return for seven more study visits. If the participants have type 2 diabetes and are taking oral diabetic medications, they will need to stop taking the medications 5 days (3 days if they are taking metformin) prior to the study visit. They will need to check their fasting finger-stick blood glucose using their glucose meter every morning. If the glucose value is greater than 240, they will not be eligible for the study.

During the first study visit, the participants will be randomly assigned to one of seven groups:

  1. actual feeding (AF) with peanut butter sandwich
  2. modified sham feeding (MSF) with peanut butter sandwich
  3. MSF with chewing and spitting Parafilm® M
  4. MSF with swishing and spitting of 900 mg of sucralose solution
  5. AF with peanut butter sandwich with sucralose added to the peanut butter
  6. AF feeding with pork rinds (1 oz or 28 grams)
  7. AF feeding with pork rinds (2 oz or 56 grams)

Blood samples will be taken through an intravenous catheter every 1-minute for 40 minutes prior to the meal and then every minute for 40 minutes at the first bite of the meal. From 40 minutes to 60 minutes after the first bite, samples will be taken every 2 minutes, and from 60 to 180 minutes, samples will be taken every 15 minutes. A total of 99 blood samples will be taken. After each of the study visits, participants will be evaluated for the need for iron supplementation.

The participant will return for each of the subsequent visits at least 6 weeks after the previous visit. The same procedures as described in study visit 1 will be done except for the intervention, which is randomized. A hematocrit will be done to assure that it is within normal limits. If not, iron supplement Ferrous Sulfate 325 mg orally once daily will be given to the participant, and they will be rescheduled for the next visit in 4-6 weeks.

Study Phase
Study Type  Observational
Study Design  Case Control, Prospective
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Diabetes Mellitus, Type 2
Prediabetic State
Healthy
Intervention  Behavioral: Actual Feeding (AF)
Behavioral: Modified Sham-Feeding (MSF)
MEDLINE PMIDs 11234504,   8285261,   8799637
Links Hormones in Taste Buds www.grc.nia.nih.gov/studies/taste.htm This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  40
Start Date  October 2005
Completion Date February 2010
Eligibility Criteria 

Inclusion Criteria:

  • Body weight > 50 kg (110 pounds)
  • Group A: healthy; body mass index (BMI) less than 25 kg/m2.
  • Group B: healthy; BMI greater than or equal to 30 kg/m2.
  • Group C: pre-diabetes or type 2 diabetes; BMI greater than or equal to 30 kg/m2.

Exclusion Criteria:

  • Pregnancy
  • Anemia
  • Peanut allergy
Gender Both
Ages 20 Years to 50 Years
Accepts Healthy Volunteers No
Contacts ††
Contact: Denise Melvin, RN     410-350-3924     melvinde@grc.nia.nih.gov    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00233298
Organization ID AG0053
Secondary IDs ††
Study Sponsor  National Institute on Aging (NIA)
Collaborators ††
Investigators 
Principal Investigator:     Josephine Egan, MD     Chief, Diabetes Section, National Institute on Aging, Intramural Research Program    
Information Provided By National Institute on Aging (NIA)
Verification Date August 2008
First Received Date  October 3, 2005
Last Updated Date August 19, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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