Cardiovascular DiseaseNCT01023906

Taste Perception and Chronic Disease Risk

An observational study of Cardiovascular Disease and Diabetes, run by Tufts University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Cardiovascular Disease, Diabetes, Obesity
How many people: 90 participants
Where: 1 siteUnited States
Study dates: Jul 2008to Mar 2010
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: Community Sample

Who may be able to join

men and women;
aged 18 to 85 years old;
free of known chronic disease;
BMI < 35 kg/ m2.

Who cannot join

BMI ≥ 35 kg/m2;
renal or liver disease;
untreated hypertension;
irritable bowel syndrome;
malabsorptive, esophageal and gastrointestinal motility disorders;
chronic pancreatitis, or history of acute pancreatitis within the last year;

Show all 18Show fewer

hypothyroidism or hypothyroidism, as defined as screening TSH outside of normal ranges;
anemia, as defined by screening hematocrit of 34% for women and 38% for men;
smoking within the past 6 months;
diabetes;
fasting glucose ≥ 125 mg/dL;
pregnancy or breastfeeding;
history of polycystic ovary syndrome;
history of autoimmune or other connective tissue disorders associated with chronic inflammation, such as rheumatoid arthritis; alcohol consumption > 7 drinks/ week;
use of medications known to affect glucose or lipid metabolism;
established CVD (myocardial infarction, stroke, heart failure, coronary artery bypass, graft, stenosis > 50%, peripheral arterial disease);
unwillingness to adhere to study protocol;
weight gain or loss of more than 15 lbs within 6 months prior to enrollment and other abnormal screening laboratory analysis results.

Trial locations and contacts

1 site in 1 country.

United States1 site

Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, 02111

Other trials in United States

About this study

Official title: Relationship Between Variations in Taste Perception and Chronic Disease Risk Factors as a Function of Age

The purpose of the Taste Perception Study is to assess variations in the ability to taste and perceive sensations from various stimuli in younger (18-49 years) and older (50-85 years) volunteers. The study's goal is to determine how these sensations influence what one likes to eat, and what one chooses to eat, and whether there is an association with dietary intake, body composition and chronic disease. Another objective of the study is to determine the association between variations in oral sensations and genes mediating sensory perception and dietary behaviours.

Read the detailed description

The objective of the Taste Perception Study is to assess variations in oral sensations in younger (18-49 years; n=35) relative to older (50-85 years; n=35) subjects, and determine the association between variations in oral sensations and measures of chronic disease risk factors, body composition, habitual dietary intake and selected genes mediating sensory perception and dietary behaviors. Subjects who are participating in the Glycemic Index study (IRB #7196) will be asked for voluntarily participation in the proposed study. These volunteers will undergo 1-2 hours of standardized testing. These tests will involve tasting or smelling certain foods/beverages or ingredients in foods/beverages and rating the degree of liking/disliking, intensity and flavor or odor using a validated general Labeled magnitude scale. Volunteers will also be asked to complete a food preference survey and eating inventory questionnaire, as well as provide a DNA sample from a cheek swab or blood sample. These data will then be merged with the measures of chronic disease risk factors, body composition and habitual dietary intake data generated from the Glycemic index study in order to better understand if variations in oral sensations influence food preferences and patterns and subsequently chronic disease risk.

Conditions: Cardiovascular Disease, Diabetes, Obesity, Metabolic Syndrome, Aging
Keywords: Taste, general Labeled Magnitude Scale, Aging, Chronic Disease Risk, Smell
Medical subject headings: Cardiovascular Diseases, Diabetes Mellitus, Obesity, Metabolic Syndrome, Anosmia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01023906
Study group	Role	What they receive
18-49 years		Younger
50-85 years		Older

What is being measured

The primary outcome is the main question the study is designed to answer.

Sensory/hedonic rating
Measured: 1 - 2 hours

Secondary outcomes (1)

Genetic Variation
Measured: 1- 2 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2008Mar 2010

First posted2 Dec 2009 (estimated)
Study startJul 2008
Primary completionMar 2010
Study completionMar 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (14)Papers the sponsor has linked to this study.
Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Cross-sectional
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01023906
Sponsor's protocol ID: Ross Aging Initiative
Status last verified: May 2014
First submitted: 30 Nov 2009
Last updated: 23 May 2014
Results posted: No
Data monitoring committee: No

Publications

Vega-Lopez S, Ausman LM, Griffith JL, Lichtenstein AH. Interindividual variability and intra-individual reproducibility of glycemic index values for commercial white bread. Diabetes Care. 2007 Jun;30(6):1412-7. doi: 10.2337/dc06-1598. Epub 2007 Mar 23.
PubMed 17384339
He W, Sengupta M, Velkoff VA, DeBarros KA. U.S. Census Bureau, Current Population Reports, 65+ in the United States: 2005. U.S. Government Printing Office, Washington DC. 2005: 23-209.
Duffy VB, Chapo AK. Smell, Taste, and Somatosensation in the Elderly. Jones and Bartlett Publishers, 2006: 115-153.
Seiberling KA, Conley DB. Aging and olfactory and taste function. Otolaryngol Clin North Am. 2004 Dec;37(6):1209-28, vii. doi: 10.1016/j.otc.2004.06.006.
PubMed 15563911
Dinehart ME, Hayes JE, Bartoshuk LM, Lanier SL, Duffy VB. Bitter taste markers explain variability in vegetable sweetness, bitterness, and intake. Physiol Behav. 2006 Feb 28;87(2):304-13. doi: 10.1016/j.physbeh.2005.10.018. Epub 2005 Dec 20.
PubMed 16368118
Bartoshuk LM, Duffy VB, Hayes JE, Moskowitz HR, Snyder DJ. Psychophysics of sweet and fat perception in obesity: problems, solutions and new perspectives. Philos Trans R Soc Lond B Biol Sci. 2006 Jul 29;361(1471):1137-48. doi: 10.1098/rstb.2006.1853.
PubMed 16815797
Drewnowski A. Taste preferences and food intake. Annu Rev Nutr. 1997;17:237-53. doi: 10.1146/annurev.nutr.17.1.237.
PubMed 9240927
Lanier SA, Hayes JE, Duffy VB. Sweet and bitter tastes of alcoholic beverages mediate alcohol intake in of-age undergraduates. Physiol Behav. 2005 Jan 17;83(5):821-31. doi: 10.1016/j.physbeh.2004.10.004. Epub 2004 Nov 21.
PubMed 15639168
Goldstein GL, Daun H, Tepper BJ. Adiposity in middle-aged women is associated with genetic taste blindness to 6-n-propylthiouracil. Obes Res. 2005 Jun;13(6):1017-23. doi: 10.1038/oby.2005.119.
PubMed 15976144
Duffy VB. Associations between oral sensation, dietary behaviors and risk of cardiovascular disease (CVD). Appetite. 2004 Aug;43(1):5-9. doi: 10.1016/j.appet.2004.02.007.
PubMed 15262011
Rolls BJ. Do chemosensory changes influence food intake in the elderly? Physiol Behav. 1999 Apr;66(2):193-7. doi: 10.1016/s0031-9384(98)00264-9.
PubMed 10336143
Bartoshuk LM, Duffy VB, Miller IJ. PTC/PROP tasting: anatomy, psychophysics, and sex effects. Physiol Behav. 1994 Dec;56(6):1165-71. doi: 10.1016/0031-9384(94)90361-1.
PubMed 7878086
Bartoshuk LM, Duffy VB, Fast K, Green BG, Prutkin K, Snyder DJ. Labeled scales (e.g. category, Likert, VAS) and across-group comparisons: what we have learned from genetic variation in taste. Food Quality and Preference 2003; 14: 125-138.
Green BG, Dalton P, Cowart B, Shaffer G, Rankin K, Higgins J. Evaluating the 'Labeled Magnitude Scale' for measuring sensations of taste and smell. Chem Senses. 1996 Jun;21(3):323-34. doi: 10.1093/chemse/21.3.323.
PubMed 8670711

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 23 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Relationship Between Variations in Taste Perception and Chronic Disease Risk Factors as a Function of Age
ClinicalTrials.gov ID: NCT01023906
Acronym / sponsor ID: Ross Aging Initiative
Conditions: Cardiovascular Disease, Diabetes, Obesity, Metabolic Syndrome, Aging
Keywords: Taste, general Labeled Magnitude Scale, Aging, Chronic Disease Risk, Smell
Study type: Observational
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: Tufts UniversityUniversity, hospital or other
Collaborators: University of Connecticut
Study start: Jul 2008
Primary completion: Mar 2010 (actual)
Study completion: Mar 2010 (actual)
First posted: 2 Dec 2009 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Cross-sectional
Number of arms: 2

Arm	Type	Receives
18-49 years	–	–Younger
50-85 years	–	–Older

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Community Sample

Key inclusion criteria (4 listed)

men and women;
aged 18 to 85 years old;
free of known chronic disease;
BMI < 35 kg/ m2.

Key exclusion criteria (18 listed)

BMI ≥ 35 kg/m2;
renal or liver disease;
untreated hypertension;
irritable bowel syndrome;
malabsorptive, esophageal and gastrointestinal motility disorders;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Sensory/hedonic rating
Time frame: 1 - 2 hours

1 secondary outcome

Genetic Variation
Time frame: 1- 2 hours

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2014.
Background: PubMed 17384339Vega-Lopez S, Ausman LM, Griffith JL, Lichtenstein AH. Interindividual variability and intra-individual reproducibility of glycemic index values for commercial white bread. Diabetes Care. 2007 Jun;30(6):1412-7. doi: 10.2337/dc06-1598. Epub 2007 Mar 23.
BackgroundHe W, Sengupta M, Velkoff VA, DeBarros KA. U.S. Census Bureau, Current Population Reports, 65+ in the United States: 2005. U.S. Government Printing Office, Washington DC. 2005: 23-209.
BackgroundDuffy VB, Chapo AK. Smell, Taste, and Somatosensation in the Elderly. Jones and Bartlett Publishers, 2006: 115-153.
Background: PubMed 15563911Seiberling KA, Conley DB. Aging and olfactory and taste function. Otolaryngol Clin North Am. 2004 Dec;37(6):1209-28, vii. doi: 10.1016/j.otc.2004.06.006.
Background: PubMed 16368118Dinehart ME, Hayes JE, Bartoshuk LM, Lanier SL, Duffy VB. Bitter taste markers explain variability in vegetable sweetness, bitterness, and intake. Physiol Behav. 2006 Feb 28;87(2):304-13. doi: 10.1016/j.physbeh.2005.10.018. Epub 2005 Dec 20.
Background: PubMed 16815797Bartoshuk LM, Duffy VB, Hayes JE, Moskowitz HR, Snyder DJ. Psychophysics of sweet and fat perception in obesity: problems, solutions and new perspectives. Philos Trans R Soc Lond B Biol Sci. 2006 Jul 29;361(1471):1137-48. doi: 10.1098/rstb.2006.1853.
Background: PubMed 9240927Drewnowski A. Taste preferences and food intake. Annu Rev Nutr. 1997;17:237-53. doi: 10.1146/annurev.nutr.17.1.237.
Background: PubMed 15639168Lanier SA, Hayes JE, Duffy VB. Sweet and bitter tastes of alcoholic beverages mediate alcohol intake in of-age undergraduates. Physiol Behav. 2005 Jan 17;83(5):821-31. doi: 10.1016/j.physbeh.2004.10.004. Epub 2004 Nov 21.
Background: PubMed 15976144Goldstein GL, Daun H, Tepper BJ. Adiposity in middle-aged women is associated with genetic taste blindness to 6-n-propylthiouracil. Obes Res. 2005 Jun;13(6):1017-23. doi: 10.1038/oby.2005.119.
Background: PubMed 15262011Duffy VB. Associations between oral sensation, dietary behaviors and risk of cardiovascular disease (CVD). Appetite. 2004 Aug;43(1):5-9. doi: 10.1016/j.appet.2004.02.007.
Background: PubMed 10336143Rolls BJ. Do chemosensory changes influence food intake in the elderly? Physiol Behav. 1999 Apr;66(2):193-7. doi: 10.1016/s0031-9384(98)00264-9.
Background: PubMed 7878086Bartoshuk LM, Duffy VB, Miller IJ. PTC/PROP tasting: anatomy, psychophysics, and sex effects. Physiol Behav. 1994 Dec;56(6):1165-71. doi: 10.1016/0031-9384(94)90361-1.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Nirupa R Matthan, Ph.D. principal investigator

HNRCA at Tufts University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiovascular Disease and Diabetes, run by Tufts University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sensory/hedonic rating (time frame: 1 - 2 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01023906, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2014.