Taste And Smell TEsting in End Stage Renal Disease (TASTE ESRD)

TASTE ESRD: Taste And Smell TEsting in End Stage Renal Disease

Malnutrition is an important complication of advanced kidney disease and impairment in smell and taste may affect nutritional status. This study will examine the association between impairment in smell and taste and nutritional and functional markers among patients with end stage renal disease, as well as risk factors for smell and taste impairment.

Study Overview

• Status: Withdrawn
• Conditions: Malnutrition; Kidney Failure, Chronic; Taste Disorders; Olfaction Disorders
• Intervention / Treatment: Other: Worsening of olfaction from enrollment visit to 6 months; Other: Worsening of taste from enrollment visit to 6 months; Other: Serum Zinc; Other: Chronic rhinosinusitis; Other: Dialysis adequacy; Other: Decayed missing filled teeth index (DMFT)

Detailed Description

People with advanced chronic kidney disease (CKD) are at risk for malnutrition, which is associated with significantly increased mortality. Impairments in olfaction and taste are under-recognized and under-addressed symptoms that affect this population. Olfaction and taste influence appetite and nutritional status and represent a unique target for study and intervention. Small cross-sectional studies have shown a higher prevalence of olfactory (up to 56%) and taste disturbances (up to 35%) among patients with CKD compared with the general population, but little is known about longitudinal change in olfaction and taste in this population. Additionally, there is a lack of understanding about why these sensory disturbances more commonly occur in people with CKD, although there is speculation that uremia may contribute.

This information gained from this study will address these gaps in knowledge by studying longitudinal changes in olfaction and taste and their associations with concurrent and future nutritional and functional status. Additionally this study will attempt to identify potentially modifiable risk factors associated with olfactory and taste impairment.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults (aged 18 or older) who have end-stage renal disease requiring chronic dialysis.

Description

Inclusion Criteria:

• Aged 18 or older
• End-stage renal disease requiring chronic dialysis

Exclusion Criteria:

• Known allergy to quinine
• Presence of a pacemaker or internal defibrillator
• Pregnancy or breastfeeding

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

End stage renal disease; Observational study, no intervention

Other: Worsening of olfaction from enrollment visit to 6 months; Worsening of olfaction from enrollment visit to 6 months will be evaluated for association with the primary and secondary outcomes; Other: Worsening of taste from enrollment visit to 6 months; Worsening of taste from enrollment visit to 6 months will be evaluated for association with the primary and secondary outcomes; Other: Serum Zinc; Serum zinc will be evaluated for association with taste and/or smell impairment; Other: Chronic rhinosinusitis; Chronic rhinosinusitis will be evaluated for association with smell impairment; Other: Dialysis adequacy; Dialysis adequacy will be evaluated for association with taste and/or smell impairment; Other: Decayed missing filled teeth index (DMFT); DMFT will be evaluated for association with taste impairment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in lean body mass	lean body mass will be determined by dual-energy X-ray absorptiometry scan	from 6 months to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in hand grip strength	measured by dynamometer	from 6 months to 1 year
change in the physical function score	measured by Standard-Form 36 version 2	from 6 months to 1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in serum albumin	change in serum albumin	from 6 months to 1 year
change in dietary intake	measured by a food frequency questionnaire	from 6 months to 1 year
change in anthropometric measures	triceps skinfold thickness, mid arm circumference, and weight	from 6 months to 1 year
change in serum cholesterol	change in serum cholesterol	from 6 months to 1 year

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Katherine Lynch, MD, SM, Beth Israel Deaconess Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2017
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: February 2, 2017
• First Submitted That Met QC Criteria: February 2, 2017
• First Posted (Estimate): February 3, 2017

Study Record Updates

• Last Update Posted (Actual): June 26, 2017
• Last Update Submitted That Met QC Criteria: June 22, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Kidney Diseases; Urologic Diseases; Neurologic Manifestations; Nutrition Disorders; Renal Insufficiency, Chronic; Sensation Disorders; Disease; Kidney Failure, Chronic; Renal Insufficiency; Malnutrition; Taste Disorders; Olfaction Disorders
• Other Study ID Numbers: 2016P000152

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No