NCT02909764

Brief Summary

The goals of the proposed research are to determine whether repeated exposure to a low sodium food will result in reduced preference for salt in that food among children; and to determine whether such reductions in preference are related to dietary intake of salt, taste receptor genotype, and anthropometric and physiological measures.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 1, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 21, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

August 20, 2019

Completed
Last Updated

September 30, 2019

Status Verified

September 1, 2019

Enrollment Period

7 months

First QC Date

September 1, 2016

Results QC Date

March 6, 2019

Last Update Submit

September 6, 2019

Conditions

Development

Keywords

Salty tastePsychophysicsGeneticsDietAge

Outcome Measures

Primary Outcomes (2)

  • Most Preferred Level of Salt Taste

    Children were presented with pairs of broths with varying concentrations of added salt (0.16, 0.24, 0.38, 0.61, 1.05 M) (17) . The first pair of broths (0.24 and 0.61 M salt) presented were from the middle range of concentrations. Children were instructed to taste each sample within a pair for 5 seconds, to rinse between tastings, and then to point to the sample they liked better. Each subsequent pair of samples contained the concentration selected by the participant paired with an adjacent stimulus concentration. This pattern continued until the child either chose the same concentration when paired with both a lower and higher concentration in two consecutive pairs or chose either the highest or the lowest concentration twice consecutively. The entire task was repeated a, with stimulus pairs presented in reverse order. The geometric mean of the two concentrations chosen in the first and second series was calculated to determine most preferred levels of salt.

    Baseline (time 0) and after 8-week intervention

  • Relative Preference for Regular vs Low Sodium Cereal

    The number of children who preferred the taste of the low salt cereal when compared to the regular sodium cereal

    At baseline and after 8-week intervention

Secondary Outcomes (4)

  • Salt Taste Detection Thresholds

    Baseline and after 8-week intervention

  • Most Preferred Level of Sucrose

    At baseline and after 8-week intervention

  • Intake of Cereal During Intervention Period

    28 days

  • Blood Pressure

    Baseline

Study Arms (2)

Control Group

NO INTERVENTION

Children will receive regularly salted cereal to consume 4 times per week over a 2-month period.

Low Sodium Group

EXPERIMENTAL

Intervention: Children will receive low sodium cereal to consume 4 times per week over a 2-month period.

Other: Low Sodium Group

Interventions

Low Sodium GroupOTHER

Breakfast Cereal

Low Sodium Group

Eligibility Criteria

Age7 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy
  • Willingness to consume no other cereals during intervention

You may not qualify if:

  • Allergies and/or taking medication that affects taste

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Monell Chemical Senses Center

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • Bobowski N, Mennella JA. Repeated Exposure to Low-Sodium Cereal Affects Acceptance but Does not Shift Taste Preferences or Detection Thresholds of Children in a Randomized Clinical Trial. J Nutr. 2019 May 1;149(5):870-876. doi: 10.1093/jn/nxz014.

    PMID: 31006818DERIVED

Limitations and Caveats

We did not collect reliable diet records so no data were available to report.

Results Point of Contact

Title
Julie A. Mennella
Organization
Monell Chemical Senses Center
mennella@monell.org
2675194880

Study Officials

  • Julie A Mennella, PhD

    Monell Chemical Senses Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2016

First Posted

September 21, 2016

Study Start

January 1, 2016

Primary Completion

August 1, 2016

Study Completion

December 1, 2016

Last Updated

September 30, 2019

Results First Posted

August 20, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)