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This is a double-blind, controlled, parallel, randomized sensory study. The study will consist of two cohorts; habitual regular full-calorie Carbonated Soft Drink (CSD) consumers and habitual low-calorie CSD consumers. Each cohort will be randomized to one of 3 interventions for six months (24 weeks):
The primary outcome is to assess the perception changes in sweetness (magnitude scale) and sweetness liking (Likert scale) of a test product and a control product over a period of six months. The study endeavors to explore whether consumers of sweetened carbonated beverages can adapt liking to lower sweetness beverages after prolonged exposure of daily consumption of beverages with step-wise reduction of sweetness, or maintenance at reduced (moderate) sweetness.
Additional analysis will be to assess dietary compensation for sweetness in the step-wise and moderate reduction arms compared to the control arms (the full calorie and low calorie control beverages). Dietary analysis of calories and intakes of total sugar, added sugar, and servings of low-/non-calorie sweeteners will be assessed using a 3-day diet record pre-intervention and monthly for 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control beverage for Habitual full-calorie CSD cohort, n=28 | Placebo Comparator | Full sweetness (sugar) for 6 months |
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| Control beverage for Habitual low-calorie CSD cohort, n=28 | Placebo Comparator | Full sweetness low calorie sweetener (LCS) with sweetness level matched to the full sweetness sugar control for 6 months |
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| Test beverage 1 for Habitual full-calorie CSD cohort, n=28 | Active Comparator | Reduced sweetness (moderate sugar level) for 6 months |
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| Test beverage 1 for Habitual low-calorie CSD cohort, n=28 | Active Comparator | Reduced sweetness low calorie sweetener (LCS) with sweetness level matched to the moderate sugar sweetness level for 6 months |
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| Test beverage 2 for Habitual full-calorie CSD cohort, n=28 | Active Comparator | Step-wise sweetness reduction over 6 months. Month 1 is the full sweetness sugar control, followed by monthly sweetness reduction. Remains at the reduced sweetness level (moderate sugar level) from months 4-6. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flavored carbonated soft drink (CSD) | Other | Beverage |
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| Measure | Description | Time Frame |
|---|---|---|
| Sweetness liking | Likert Scale, 9 point scale from 1=Dislike extremely to 9=Like extremely | Changes over a period of 6 months, measured at monthly intervals from month 0 (baseline) to month 6 |
| Sweetness intensity perception | Magnitude scale ranging from Barely perceptible to Strongest imaginable sweetness | Changes over a period of 6 months, measured at monthly intervals from month 0 (baseline) to month 6 |
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| Measure | Description | Time Frame |
|---|---|---|
| Dietary compensation for sweetness | 3-day diet record to assess calories and intake of total sugar, added sugar, low-/non calorie sweeteners | Changes over a period of 6 months, measured at monthly intervals from month 0 (baseline) to month 6 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathleen Kelley, MD | Biofortis Innovation Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BioFortis Innovation Services | Addison | Illinois | 60101 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39500957 | Derived | Mah E, Kamil A, Blonquist TM, Rehm CD, Qu S, Stern P, Wilson AR. Change in liking following reduction in sweetness level of carbonated beverages: a randomized controlled parallel trial. Sci Rep. 2024 Nov 5;14(1):26742. doi: 10.1038/s41598-024-77529-w. |
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Same packaging for all (cans). Color and flavor matched.
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| Test beverage 2 for Habitual low-calorie CSD cohort, n=28 | Active Comparator | Step-wise sweetness reduction over 6 months. Month 1 is the low calorie sweetener (LCS) sweetness equivalent of the full sweetness sugar control, followed by monthly LCS sweetness reduction (reductions equivalent to the corresponding sugar reduction arm sweetness levels). Remains at the reduced sweetness level (LCS equivalent of moderate sugar sweetness level) from months 4-6. |
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