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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Sodium Group | Other | Breakfast Cereal |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Most Preferred Level of Sucrose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julie A Mennella, PhD | Monell Chemical Senses Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Monell Chemical Senses Center | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31006818 | Derived | 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. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group [Regular Sodium Group] | Children will receive regularly salted cereal to consume 4 times per week over an 8-week (2-month) period. |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group [Regular Sodium Group] | Children will receive regularly salted cereal to consume 4 times per week over a 2-month period. |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Some children did not understand the task and responded at random. | Posted | Geometric Mean | Standard Error | mol/L | Baseline (time 0) and after 8-week intervention |
4 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group [Regular Sodium Group] | Children will receive regularly salted cereal to consume 4 times per week over an 8-week (2-month) period. |
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We did not collect reliable diet records so no data were available to report.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julie A. Mennella | Monell Chemical Senses Center | 2675194880 | mennella@monell.org |
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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 |
| 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 |
| 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 |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Control Group [Regular Sodium Group] | Children will receive regularly salted cereal to consume 4 times per week over a 2-month period. |
| OG001 | 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 |
|
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| 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 | Posted | Count of Participants | Participants | At baseline and after 8-week intervention |
|
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|
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| Secondary | Salt Taste Detection Thresholds | Detection thresholds (the lowest level of salt detect by taste) were measured via a two-alternative forced-choice procedure | Some children did not understand or complete the task. | Posted | Mean | Standard Error | mol x 10-3/L | Baseline and after 8-week intervention |
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| 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. | Posted | Geometric Mean | Standard Error | mol/L | At baseline and after 8-week intervention |
|
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| 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. | Posted | Mean | Standard Error | grams | 28 days |
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| 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. | Posted | Mean | Standard Error | mmHg | Baseline |
|
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| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | 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 | 0 | 20 | 0 | 20 | 0 | 20 |
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