Taste Perception and Chronic Disease Risk

May 21, 2014 updated by: Tufts University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Community Sample

Description

Inclusion Criteria:

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

Exclusion criteria:

  • 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;
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
18-49 years
Younger
50-85 years
Older

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Sensory/hedonic rating
Time Frame: 1 - 2 hours
1 - 2 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Genetic Variation
Time Frame: 1- 2 hours
1- 2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tufts University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Connecticut

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nirupa R Matthan, Ph.D., HNRCA at Tufts University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 30, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 2, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 23, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Ross Aging Initiative

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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