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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   Information provided by National Institute on Aging (NIA)
First Received: October 3, 2005   Last Updated: May 28, 2009   History of Changes

October 3, 2005
May 28, 2009
October 2005
February 2010   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00233298 on ClinicalTrials.gov Archive Site
 
 
 
Taste Study: A Study of the Function of Hormones Present in Taste Buds
A Study of the Function of Hormones Present in Taste Buds

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.

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.

 
Observational
Case Control, Prospective
  • Diabetes Mellitus, Type 2
  • Prediabetic State
  • Healthy
  • Behavioral: Actual Feeding (AF)
  • Behavioral: Modified Sham-Feeding (MSF)
  • Actual Feeding (AF) with peanut butter sandwich
  • Modified Sham Feeding (MSF) with peanut butter sandwich
  • MSF with chewing and spitting Parafilm® M
  • MSF with swishing and spitting of 900 mg of sucralose solution
  • AF with peanut butter sandwich with sucralose added to the peanut butter
  • AF feeding with pork rinds (1 oz or 28 grams)
  • AF feeding with pork rinds (2 oz or 56 grams)

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
40
February 2010
February 2010   (final data collection date for primary outcome measure)

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
Both
20 Years to 50 Years
No
Contact: Denise Melvin, RN 410-350-3924 melvinde@grc.nia.nih.gov
Contact: NIA Recruiter 410-350-3941
United States
 
NCT00233298
Josephine Egan, MD, Principle Investigator, National Institute of Aging
AG0053
National Institute on Aging (NIA)
 
Principal Investigator: Josephine Egan, MD Chief, Diabetes Section, National Institute on Aging, Intramural Research Program
National Institute on Aging (NIA)
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP