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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02909764
Other study ID # 823281
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2016
Est. completion date December 2016

Study information

Verified date September 2019
Source Monell Chemical Senses Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

This is a within- and between-subjects randomized controlled trial on children consuming either a low sodium or a higher sodium cereal over a 2-month period to determine if repeated exposure to the low sodium cereal is effective for reducing preference for salt in that food. Children will be genotyped for markers related to taste, dietary intake will be recorded, and anthropometric and physiological measures will be collected at baseline.


Recruitment information / eligibility

Status Completed
Enrollment 39
Est. completion date December 2016
Est. primary completion date August 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 7 Years to 65 Years
Eligibility Inclusion Criteria:

- Healthy

- Willingness to consume no other cereals during intervention

Exclusion Criteria:

- Allergies and/or taking medication that affects taste

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Low Sodium Group
Breakfast Cereal

Locations

Country Name City State
United States Monell Chemical Senses Center Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Monell Chemical Senses Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Salt Taste Detection Thresholds Detection thresholds (the lowest level of salt detect by taste) were measured via a two-alternative forced-choice procedure Baseline and after 8-week intervention
Secondary Most Preferred Level of Sucrose Children were presented with pairs of sucrose solutions of varying concentrations (0.09, 0.18, 0.35, 0.70, 1.05 M). The first pair presented were from the middle range of concentrations. Children tasted each sample and then pointed to the sample they liked better. Each subsequent pair of samples presented contained the concentration selected by the child 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 after a 3-minute break, 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 the most preferred levels of sucrose. At baseline and after 8-week intervention
Secondary Intake of Cereal During Intervention Period Mothers recorded the amount of cereal their children ingested during 28 days of the 8-week, at-home intervention period. 28 days
Secondary Blood Pressure Blood pressure (mmHg) was measured by using an automatic blood pressure machine with pediatric cuff. Blood pressure will be measured at baseline (time 0). There were no a priori hypothesis but were collected as baseline characteristic to ensure no differences between the groups. Baseline
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