Trial Outcomes & Findings for Shifting Salty Taste Preferences in Children (NCT NCT02909764)
NCT ID: NCT02909764
Last Updated: 2019-09-30
Results Overview
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.
COMPLETED
NA
39 participants
Baseline (time 0) and after 8-week intervention
2019-09-30
Participant Flow
Mothers were recruited from a list of past participants in our research program who asked to be contacted for future studies. Study was conducted at The Monell Chemical Senses Center in Philadelphia, Pennsylvania USA in 2016.
Children were randomized at the beginning of the first test session. There were no significant effects that occurred after participant enrollment but before randomization to study group.
Participant milestones
| Measure |
Control Group [Regular Sodium Group]
Children will receive regularly salted cereal to consume 4 times per week over an 8-week (2-month) period.
|
Low Sodium Group
Intervention: Children will receive low sodium cereal to consume 4 times per week over an 8-week (2-month) period.
Low Sodium Group: Breakfast Cereal
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
20
|
|
Overall Study
COMPLETED
|
19
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Shifting Salty Taste Preferences in Children
Baseline characteristics by cohort
| Measure |
Control Group [Regular Sodium Group]
n=19 Participants
Children will receive regularly salted cereal to consume 4 times per week over a 2-month period.
|
Low Sodium Group
n=20 Participants
Intervention: Children will receive low sodium cereal to consume 4 times per week over a 2-month period.
Low Sodium Group: Breakfast Cereal
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
11.4 years
STANDARD_DEVIATION 2.3 • n=99 Participants
|
11.3 years
STANDARD_DEVIATION 2.2 • n=107 Participants
|
11.3 years
STANDARD_DEVIATION 2.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline (time 0) and after 8-week interventionPopulation: Some children did not understand the task and responded at random.
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.
Outcome measures
| Measure |
Control Group [Regular Sodium Group]
n=19 Participants
Children will receive regularly salted cereal to consume 4 times per week over a 2-month period.
|
Low Sodium Group
n=20 Participants
Intervention: Children will receive low sodium cereal to consume 4 times per week over a 2-month period.
Low Sodium Group: Breakfast Cereal
|
|---|---|---|
|
Most Preferred Level of Salt Taste
Baseline
|
0.44 mol/L
Standard Error 0.04
|
0.34 mol/L
Standard Error 0.04
|
|
Most Preferred Level of Salt Taste
After 8-week intervention
|
0.42 mol/L
Standard Error 0.05
|
0.43 mol/L
Standard Error 0.05
|
PRIMARY outcome
Timeframe: At baseline and after 8-week interventionThe number of children who preferred the taste of the low salt cereal when compared to the regular sodium cereal
Outcome measures
| Measure |
Control Group [Regular Sodium Group]
n=19 Participants
Children will receive regularly salted cereal to consume 4 times per week over a 2-month period.
|
Low Sodium Group
n=20 Participants
Intervention: Children will receive low sodium cereal to consume 4 times per week over a 2-month period.
Low Sodium Group: Breakfast Cereal
|
|---|---|---|
|
Relative Preference for Regular vs Low Sodium Cereal
Baseline, Number preferred low salt cereal
|
3 Participants
|
5 Participants
|
|
Relative Preference for Regular vs Low Sodium Cereal
End Intervention, Number preferred low salt cereal
|
7 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline and after 8-week interventionPopulation: Some children did not understand or complete the task.
Detection thresholds (the lowest level of salt detect by taste) were measured via a two-alternative forced-choice procedure
Outcome measures
| Measure |
Control Group [Regular Sodium Group]
n=19 Participants
Children will receive regularly salted cereal to consume 4 times per week over a 2-month period.
|
Low Sodium Group
n=20 Participants
Intervention: Children will receive low sodium cereal to consume 4 times per week over a 2-month period.
Low Sodium Group: Breakfast Cereal
|
|---|---|---|
|
Salt Taste Detection Thresholds
Baseline
|
4.4 mol x 10-3/L
Standard Error 0.8
|
3.6 mol x 10-3/L
Standard Error 0.8
|
|
Salt Taste Detection Thresholds
After 8-week Exposure Period
|
4.6 mol x 10-3/L
Standard Error 1.0
|
5.4 mol x 10-3/L
Standard Error 1.1
|
SECONDARY outcome
Timeframe: At baseline and after 8-week interventionChildren 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.
Outcome measures
| Measure |
Control Group [Regular Sodium Group]
n=19 Participants
Children will receive regularly salted cereal to consume 4 times per week over a 2-month period.
|
Low Sodium Group
n=20 Participants
Intervention: Children will receive low sodium cereal to consume 4 times per week over a 2-month period.
Low Sodium Group: Breakfast Cereal
|
|---|---|---|
|
Most Preferred Level of Sucrose
After 8-week intervention
|
0.76 mol/L
Standard Error 0.06
|
0.64 mol/L
Standard Error 0.06
|
|
Most Preferred Level of Sucrose
Baseline
|
0.72 mol/L
Standard Error 0.07
|
0.57 mol/L
Standard Error 0.07
|
SECONDARY outcome
Timeframe: 28 daysMothers recorded the amount of cereal their children ingested during 28 days of the 8-week, at-home intervention period.
Outcome measures
| Measure |
Control Group [Regular Sodium Group]
n=19 Participants
Children will receive regularly salted cereal to consume 4 times per week over a 2-month period.
|
Low Sodium Group
n=20 Participants
Intervention: Children will receive low sodium cereal to consume 4 times per week over a 2-month period.
Low Sodium Group: Breakfast Cereal
|
|---|---|---|
|
Intake of Cereal During Intervention Period
Intake, Day 26
|
23.5 grams
Standard Error 4.7
|
13.7 grams
Standard Error 5.2
|
|
Intake of Cereal During Intervention Period
Intake, Day 1
|
27.8 grams
Standard Error 4.3
|
19.3 grams
Standard Error 4.7
|
|
Intake of Cereal During Intervention Period
Intake, Day 2
|
33.3 grams
Standard Error 4.3
|
17.9 grams
Standard Error 4.7
|
|
Intake of Cereal During Intervention Period
Intake, Day 3
|
30.6 grams
Standard Error 4.3
|
18.9 grams
Standard Error 4.7
|
|
Intake of Cereal During Intervention Period
Intake, Day 4
|
34.8 grams
Standard Error 4.3
|
19.8 grams
Standard Error 4.7
|
|
Intake of Cereal During Intervention Period
Intake, Day 5
|
25.7 grams
Standard Error 4.3
|
20.3 grams
Standard Error 4.7
|
|
Intake of Cereal During Intervention Period
Intake, Day 6
|
27.8 grams
Standard Error 4.3
|
19.4 grams
Standard Error 4.7
|
|
Intake of Cereal During Intervention Period
Intake, Day 7
|
27.0 grams
Standard Error 4.3
|
20.3 grams
Standard Error 4.7
|
|
Intake of Cereal During Intervention Period
Intake, Day 8
|
24.9 grams
Standard Error 4.3
|
19.3 grams
Standard Error 4.7
|
|
Intake of Cereal During Intervention Period
Intake, Day 9
|
24.9 grams
Standard Error 4.3
|
16.5 grams
Standard Error 4.7
|
|
Intake of Cereal During Intervention Period
Intake, Day 10
|
23.4 grams
Standard Error 4.3
|
17.6 grams
Standard Error 4.7
|
|
Intake of Cereal During Intervention Period
Intake, Day 11
|
25.9 grams
Standard Error 4.3
|
16.5 grams
Standard Error 4.7
|
|
Intake of Cereal During Intervention Period
Intake, Day 12
|
24.5 grams
Standard Error 4.3
|
15.3 grams
Standard Error 4.7
|
|
Intake of Cereal During Intervention Period
Intake, Day 13
|
24.5 grams
Standard Error 4.3
|
17.7 grams
Standard Error 4.9
|
|
Intake of Cereal During Intervention Period
Intake, Day 14
|
24.9 grams
Standard Error 4.3
|
15.4 grams
Standard Error 4.9
|
|
Intake of Cereal During Intervention Period
Intake, Day 15
|
24.2 grams
Standard Error 4.4
|
19.4 grams
Standard Error 4.9
|
|
Intake of Cereal During Intervention Period
Intake, Day 16
|
23.2 grams
Standard Error 4.4
|
18.9 grams
Standard Error 5.0
|
|
Intake of Cereal During Intervention Period
Intake, Day 17
|
24.2 grams
Standard Error 4.7
|
13.9 grams
Standard Error 5.2
|
|
Intake of Cereal During Intervention Period
Intake, Day 18
|
27.0 grams
Standard Error 4.7
|
15.7 grams
Standard Error 5.2
|
|
Intake of Cereal During Intervention Period
Intake, Day 19
|
23.7 grams
Standard Error 4.7
|
12.6 grams
Standard Error 5.2
|
|
Intake of Cereal During Intervention Period
Intake, Day 20
|
21.8 grams
Standard Error 4.7
|
14.3 grams
Standard Error 5.2
|
|
Intake of Cereal During Intervention Period
Intake, Day 21
|
20.2 grams
Standard Error 4.7
|
16.4 grams
Standard Error 5.2
|
|
Intake of Cereal During Intervention Period
Intake, Day 22
|
25.9 grams
Standard Error 4.7
|
15.7 grams
Standard Error 5.2
|
|
Intake of Cereal During Intervention Period
Intake, Day 23
|
23.8 grams
Standard Error 4.7
|
12.5 grams
Standard Error 5.2
|
|
Intake of Cereal During Intervention Period
Intake, Day 24
|
23.0 grams
Standard Error 4.7
|
11.3 grams
Standard Error 5.2
|
|
Intake of Cereal During Intervention Period
Intake, Day 25
|
25.8 grams
Standard Error 4.7
|
15.7 grams
Standard Error 5.2
|
|
Intake of Cereal During Intervention Period
Intake, Day 27
|
19.0 grams
Standard Error 4.7
|
12.5 grams
Standard Error 5.2
|
|
Intake of Cereal During Intervention Period
Intake, Day 28
|
23.0 grams
Standard Error 4.7
|
10.7 grams
Standard Error 5.2
|
SECONDARY outcome
Timeframe: BaselineBlood 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.
Outcome measures
| Measure |
Control Group [Regular Sodium Group]
n=18 Participants
Children will receive regularly salted cereal to consume 4 times per week over a 2-month period.
|
Low Sodium Group
n=20 Participants
Intervention: Children will receive low sodium cereal to consume 4 times per week over a 2-month period.
Low Sodium Group: Breakfast Cereal
|
|---|---|---|
|
Blood Pressure
Systolic, baseline
|
113.7 mmHg
Standard Error 2.7
|
115.5 mmHg
Standard Error 2.9
|
|
Blood Pressure
Diastolic, baseline
|
65.1 mmHg
Standard Error 1.3
|
66.6 mmHg
Standard Error 1.4
|
Adverse Events
Control Group [Regular Sodium Group]
Low Sodium Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place