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

This study is currently recruiting participants.
Verified by National Institute on Aging (NIA), August 2008

Sponsored by: National Institute on Aging (NIA)
Information provided by: National Institute on Aging (NIA)
ClinicalTrials.gov Identifier: NCT00233298
  Purpose

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.


Condition Intervention
Diabetes Mellitus, Type 2
Prediabetic State
Healthy
Behavioral: Actual Feeding (AF)
Behavioral: Modified Sham-Feeding (MSF)

MedlinePlus related topics:   Diabetes   

ChemIDplus related topics:   Insulin    Dextrose   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Case Control, Prospective
Official Title:   A Study of the Function of Hormones Present in Taste Buds

Further study details as provided by National Institute on Aging (NIA):

Biospecimen Retention:   Samples Without DNA

Biospecimen Description:

Blood serum


Estimated Enrollment:   40
Study Start Date:   October 2005
Estimated Study Completion Date:   February 2010
Estimated Primary Completion Date:   February 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts Assigned Interventions
1
Actual Feeding (AF) with peanut butter sandwich
Behavioral: Actual Feeding (AF)
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.
2
Modified Sham Feeding (MSF) with peanut butter sandwich
Behavioral: Modified Sham-Feeding (MSF)
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.
3
MSF with chewing and spitting Parafilm® M
Behavioral: Modified Sham-Feeding (MSF)
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.
4
MSF with swishing and spitting of 900 mg of sucralose solution
Behavioral: Modified Sham-Feeding (MSF)
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.
5
AF with peanut butter sandwich with sucralose added to the peanut butter
Behavioral: Actual Feeding (AF)
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.
6
AF feeding with pork rinds (1 oz or 28 grams)
Behavioral: Actual Feeding (AF)
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.
7
AF feeding with pork rinds (2 oz or 56 grams)
Behavioral: Actual Feeding (AF)
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.

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.

  Eligibility
Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample

Study Population

Community


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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00233298

Contacts
Contact: Denise Melvin, RN     410-350-3924     melvinde@grc.nia.nih.gov    

Locations
United States, Maryland
National Institute on Aging, Clinical Research Branch     Recruiting
      Baltimore, Maryland, United States, 21225
      Contact: Denise Melvin, RN     410-350-3924     melvinde@grc.nia.nih.gov    
      Contact: NIA Recruiter     410-350-3941     NIAStudiesRecruitment@mail.nih.gov    
      Sub-Investigator: Chee Chia, MD            

Sponsors and Collaborators

Investigators
Principal Investigator:     Josephine Egan, MD     Chief, Diabetes Section, National Institute on Aging, Intramural Research Program    
  More Information

Hormones in Taste Buds www.grc.nia.nih.gov/studies/taste.htm  This link exits the ClinicalTrials.gov site
 

Publications:

Responsible Party:   National Institute of Aging ( Josephine Egan, MD, Principle Investigator )
Study ID Numbers:   AG0053
First Received:   October 3, 2005
Last Updated:   August 19, 2008
ClinicalTrials.gov Identifier:   NCT00233298
Health Authority:   United States: Federal Government

Keywords provided by National Institute on Aging (NIA):
hypoglycemia  
blood sugar  
blood glucose level  
insulin sensitivity  
metabolism
Type 2 Diabetes
Healthy

Study placed in the following topic categories:
Metabolic Diseases
Diabetes Mellitus, Type 2
Prediabetic State
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Healthy
Metabolic disorder
Glucose Metabolism Disorders
Hypoglycemia
Insulin

ClinicalTrials.gov processed this record on September 05, 2008




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