Development
Conditions
Keywords
Salty taste, Psychophysics, Genetics, Diet, Age
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.
Detailed 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.
Interventions
OTHERLow Sodium Group
Breakfast Cereal
Sponsors
Monell Chemical Senses Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
7 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy * Willingness to consume no other cereals during intervention
Exclusion criteria
* Allergies and/or taking medication that affects taste
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Most Preferred Level of Salt Taste | Baseline (time 0) and after 8-week intervention | 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. |
| Relative Preference for Regular vs Low Sodium Cereal | At baseline and after 8-week intervention | The number of children who preferred the taste of the low salt cereal when compared to the regular sodium cereal |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Salt Taste Detection Thresholds | Baseline and after 8-week intervention | Detection thresholds (the lowest level of salt detect by taste) were measured via a two-alternative forced-choice procedure |
| Most Preferred Level of Sucrose | At baseline and after 8-week intervention | 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. |
| Intake of Cereal During Intervention Period | 28 days | Mothers recorded the amount of cereal their children ingested during 28 days of the 8-week, at-home intervention period. |
| Blood Pressure | Baseline | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Control Group [Regular Sodium Group] Children will receive regularly salted cereal to consume 4 times per week over a 2-month period. | 19 |
| Low Sodium Group Intervention: Children will receive low sodium cereal to consume 4 times per week over a 2-month period.
Low Sodium Group: Breakfast Cereal | 20 |
| Total | 39 |
Baseline characteristics
| Characteristic | Low Sodium Group | Total | Control Group [Regular Sodium Group] |
|---|---|---|---|
| Age, Continuous | 11.3 years STANDARD_DEVIATION 2.2 | 11.3 years STANDARD_DEVIATION 2.2 | 11.4 years STANDARD_DEVIATION 2.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants | 26 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 8 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 5 Participants | 3 Participants |
| Sex: Female, Male Female | 13 Participants | 26 Participants | 13 Participants |
| Sex: Female, Male Male | 7 Participants | 13 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 20 |
| other Total, other adverse events | 0 / 19 | 0 / 20 |
| serious Total, serious adverse events | 0 / 19 | 0 / 20 |
Outcome results
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.
Time frame: Baseline (time 0) and after 8-week intervention
Population: Some children did not understand the task and responded at random.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group [Regular Sodium Group] | Most Preferred Level of Salt Taste | Baseline | 0.44 mol/L | Standard Error 0.04 |
| Control Group [Regular Sodium Group] | Most Preferred Level of Salt Taste | After 8-week intervention | 0.42 mol/L | Standard Error 0.05 |
| Low Sodium Group | Most Preferred Level of Salt Taste | Baseline | 0.34 mol/L | Standard Error 0.04 |
| Low Sodium Group | Most Preferred Level of Salt Taste | After 8-week intervention | 0.43 mol/L | Standard Error 0.05 |
p-value: 0.3ANOVA
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
Time frame: At baseline and after 8-week intervention
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control Group [Regular Sodium Group] | Relative Preference for Regular vs Low Sodium Cereal | Baseline, Number preferred low salt cereal | 3 Participants |
| Control Group [Regular Sodium Group] | Relative Preference for Regular vs Low Sodium Cereal | End Intervention, Number preferred low salt cereal | 7 Participants |
| Low Sodium Group | Relative Preference for Regular vs Low Sodium Cereal | Baseline, Number preferred low salt cereal | 5 Participants |
| Low Sodium Group | Relative Preference for Regular vs Low Sodium Cereal | End Intervention, Number preferred low salt cereal | 4 Participants |
Comparison: Yates's chi-square analyses were used to determine which of the two cereals children in each group preferred at baseline and after the 8-week exposure period, and whether the number of children who shifted preference from the regular cereal at baseline to the low salt cereal after the exposure period differed between groups.p-value: <0.05Chi-squared
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.
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group [Regular Sodium Group] | Blood Pressure | Systolic, baseline | 113.7 mmHg | Standard Error 2.7 |
| Control Group [Regular Sodium Group] | Blood Pressure | Diastolic, baseline | 65.1 mmHg | Standard Error 1.3 |
| Low Sodium Group | Blood Pressure | Systolic, baseline | 115.5 mmHg | Standard Error 2.9 |
| Low Sodium Group | Blood Pressure | Diastolic, baseline | 66.6 mmHg | Standard Error 1.4 |
Comparison: T-tests were conducted to determine whether differences in baseline blood pressure between the two groups.p-value: >0.4t-test, 2 sided
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.
Time frame: 28 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group [Regular Sodium Group] | Intake of Cereal During Intervention Period | Intake, Day 26 | 23.5 grams | Standard Error 4.7 |
| Control Group [Regular Sodium Group] | Intake of Cereal During Intervention Period | Intake, Day 6 | 27.8 grams | Standard Error 4.3 |
| Control Group [Regular Sodium Group] | Intake of Cereal During Intervention Period | Intake, Day 7 | 27.0 grams | Standard Error 4.3 |
| Control Group [Regular Sodium Group] | Intake of Cereal During Intervention Period | Intake, Day 8 | 24.9 grams | Standard Error 4.3 |
| Control Group [Regular Sodium Group] | Intake of Cereal During Intervention Period | Intake, Day 9 | 24.9 grams | Standard Error 4.3 |
| Control Group [Regular Sodium Group] | Intake of Cereal During Intervention Period | Intake, Day 10 | 23.4 grams | Standard Error 4.3 |
| Control Group [Regular Sodium Group] | Intake of Cereal During Intervention Period | Intake, Day 11 | 25.9 grams | Standard Error 4.3 |
| Control Group [Regular Sodium Group] | Intake of Cereal During Intervention Period | Intake, Day 12 | 24.5 grams | Standard Error 4.3 |
| Control Group [Regular Sodium Group] | Intake of Cereal During Intervention Period | Intake, Day 13 | 24.5 grams | Standard Error 4.3 |
| Control Group [Regular Sodium Group] | Intake of Cereal During Intervention Period | Intake, Day 14 | 24.9 grams | Standard Error 4.3 |
| Control Group [Regular Sodium Group] | Intake of Cereal During Intervention Period | Intake, Day 15 | 24.2 grams | Standard Error 4.4 |
| Control Group [Regular Sodium Group] | Intake of Cereal During Intervention Period | Intake, Day 16 | 23.2 grams | Standard Error 4.4 |
| Control Group [Regular Sodium Group] | Intake of Cereal During Intervention Period | Intake, Day 17 | 24.2 grams | Standard Error 4.7 |
| Control Group [Regular Sodium Group] | Intake of Cereal During Intervention Period | Intake, Day 18 | 27.0 grams | Standard Error 4.7 |
| Control Group [Regular Sodium Group] | Intake of Cereal During Intervention Period | Intake, Day 19 | 23.7 grams | Standard Error 4.7 |
| Control Group [Regular Sodium Group] | Intake of Cereal During Intervention Period | Intake, Day 20 | 21.8 grams | Standard Error 4.7 |
| Control Group [Regular Sodium Group] | Intake of Cereal During Intervention Period | Intake, Day 21 | 20.2 grams | Standard Error 4.7 |
| Control Group [Regular Sodium Group] | Intake of Cereal During Intervention Period | Intake, Day 22 | 25.9 grams | Standard Error 4.7 |
| Control Group [Regular Sodium Group] | Intake of Cereal During Intervention Period | Intake, Day 23 | 23.8 grams | Standard Error 4.7 |
| Control Group [Regular Sodium Group] | Intake of Cereal During Intervention Period | Intake, Day 24 | 23.0 grams | Standard Error 4.7 |
| Control Group [Regular Sodium Group] | Intake of Cereal During Intervention Period | Intake, Day 25 | 25.8 grams | Standard Error 4.7 |
| Control Group [Regular Sodium Group] | Intake of Cereal During Intervention Period | Intake, Day 27 | 19.0 grams | Standard Error 4.7 |
| Control Group [Regular Sodium Group] | Intake of Cereal During Intervention Period | Intake, Day 28 | 23.0 grams | Standard Error 4.7 |
| Control Group [Regular Sodium Group] | Intake of Cereal During Intervention Period | Intake, Day 1 | 27.8 grams | Standard Error 4.3 |
| Control Group [Regular Sodium Group] | Intake of Cereal During Intervention Period | Intake, Day 2 | 33.3 grams | Standard Error 4.3 |
| Control Group [Regular Sodium Group] | Intake of Cereal During Intervention Period | Intake, Day 3 | 30.6 grams | Standard Error 4.3 |
| Control Group [Regular Sodium Group] | Intake of Cereal During Intervention Period | Intake, Day 4 | 34.8 grams | Standard Error 4.3 |
| Control Group [Regular Sodium Group] | Intake of Cereal During Intervention Period | Intake, Day 5 | 25.7 grams | Standard Error 4.3 |
| Low Sodium Group | Intake of Cereal During Intervention Period | Intake, Day 19 | 12.6 grams | Standard Error 5.2 |
| Low Sodium Group | Intake of Cereal During Intervention Period | Intake, Day 3 | 18.9 grams | Standard Error 4.7 |
| Low Sodium Group | Intake of Cereal During Intervention Period | Intake, Day 6 | 19.4 grams | Standard Error 4.7 |
| Low Sodium Group | Intake of Cereal During Intervention Period | Intake, Day 20 | 14.3 grams | Standard Error 5.2 |
| Low Sodium Group | Intake of Cereal During Intervention Period | Intake, Day 7 | 20.3 grams | Standard Error 4.7 |
| Low Sodium Group | Intake of Cereal During Intervention Period | Intake, Day 27 | 12.5 grams | Standard Error 5.2 |
| Low Sodium Group | Intake of Cereal During Intervention Period | Intake, Day 8 | 19.3 grams | Standard Error 4.7 |
| Low Sodium Group | Intake of Cereal During Intervention Period | Intake, Day 21 | 16.4 grams | Standard Error 5.2 |
| Low Sodium Group | Intake of Cereal During Intervention Period | Intake, Day 9 | 16.5 grams | Standard Error 4.7 |
| Low Sodium Group | Intake of Cereal During Intervention Period | Intake, Day 2 | 17.9 grams | Standard Error 4.7 |
| Low Sodium Group | Intake of Cereal During Intervention Period | Intake, Day 10 | 17.6 grams | Standard Error 4.7 |
| Low Sodium Group | Intake of Cereal During Intervention Period | Intake, Day 22 | 15.7 grams | Standard Error 5.2 |
| Low Sodium Group | Intake of Cereal During Intervention Period | Intake, Day 11 | 16.5 grams | Standard Error 4.7 |
| Low Sodium Group | Intake of Cereal During Intervention Period | Intake, Day 28 | 10.7 grams | Standard Error 5.2 |
| Low Sodium Group | Intake of Cereal During Intervention Period | Intake, Day 12 | 15.3 grams | Standard Error 4.7 |
| Low Sodium Group | Intake of Cereal During Intervention Period | Intake, Day 23 | 12.5 grams | Standard Error 5.2 |
| Low Sodium Group | Intake of Cereal During Intervention Period | Intake, Day 13 | 17.7 grams | Standard Error 4.9 |
| Low Sodium Group | Intake of Cereal During Intervention Period | Intake, Day 4 | 19.8 grams | Standard Error 4.7 |
| Low Sodium Group | Intake of Cereal During Intervention Period | Intake, Day 14 | 15.4 grams | Standard Error 4.9 |
| Low Sodium Group | Intake of Cereal During Intervention Period | Intake, Day 24 | 11.3 grams | Standard Error 5.2 |
| Low Sodium Group | Intake of Cereal During Intervention Period | Intake, Day 15 | 19.4 grams | Standard Error 4.9 |
| Low Sodium Group | Intake of Cereal During Intervention Period | Intake, Day 1 | 19.3 grams | Standard Error 4.7 |
| Low Sodium Group | Intake of Cereal During Intervention Period | Intake, Day 16 | 18.9 grams | Standard Error 5 |
| Low Sodium Group | Intake of Cereal During Intervention Period | Intake, Day 25 | 15.7 grams | Standard Error 5.2 |
| Low Sodium Group | Intake of Cereal During Intervention Period | Intake, Day 17 | 13.9 grams | Standard Error 5.2 |
| Low Sodium Group | Intake of Cereal During Intervention Period | Intake, Day 5 | 20.3 grams | Standard Error 4.7 |
| Low Sodium Group | Intake of Cereal During Intervention Period | Intake, Day 18 | 15.7 grams | Standard Error 5.2 |
| Low Sodium Group | Intake of Cereal During Intervention Period | Intake, Day 26 | 13.7 grams | Standard Error 5.2 |
Comparison: Generalized estimating equations (GEE) were conducted on the amount of cereal in grams ingested during 28 days home-exposure period. The GEE approach accounts for the repeated measurements of outcomes over time for each child and examines whether the slopes of the lines created differ between the treatment groups.p-value: <0.05GEE
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.
Time frame: At baseline and after 8-week intervention
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group [Regular Sodium Group] | Most Preferred Level of Sucrose | Baseline | 0.72 mol/L | Standard Error 0.07 |
| Control Group [Regular Sodium Group] | Most Preferred Level of Sucrose | After 8-week intervention | 0.76 mol/L | Standard Error 0.06 |
| Low Sodium Group | Most Preferred Level of Sucrose | Baseline | 0.57 mol/L | Standard Error 0.07 |
| Low Sodium Group | Most Preferred Level of Sucrose | After 8-week intervention | 0.64 mol/L | Standard Error 0.06 |
p-value: 0.77ANOVA
Secondary
Salt Taste Detection Thresholds
Detection thresholds (the lowest level of salt detect by taste) were measured via a two-alternative forced-choice procedure
Time frame: Baseline and after 8-week intervention
Population: Some children did not understand or complete the task.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group [Regular Sodium Group] | Salt Taste Detection Thresholds | After 8-week Exposure Period | 4.6 mol x 10-3/L | Standard Error 1 |
| Control Group [Regular Sodium Group] | Salt Taste Detection Thresholds | Baseline | 4.4 mol x 10-3/L | Standard Error 0.8 |
| Low Sodium Group | Salt Taste Detection Thresholds | Baseline | 3.6 mol x 10-3/L | Standard Error 0.8 |
| Low Sodium Group | Salt Taste Detection Thresholds | After 8-week Exposure Period | 5.4 mol x 10-3/L | Standard Error 1.1 |
p-value: 0.32ANOVA