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| Name | Class |
|---|---|
| Bournemouth University | OTHER |
| TKI Agri & Food | INDUSTRY |
| Next Food Collective | UNKNOWN |
| American Beverage Association |
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In recent years, social pressure has been exerted towards lowering sugar and sweetness levels in foods, with the aim of decreasing the sweetness preference of the general population. However, the resilience/flexibility of sweetness preferences and the impact on energy intake is a fundamental knowledge gap. Recent, relatively long-term studies limited to no more than 3 months did not find a relationship between sweetness exposure and sweetness preferences. Therefore, a longer-term systematic investigation is necessary to objectively evaluate whether sweetness preferences can be altered via varying the sweetness exposure and whether it can affect other outcomes, such as perceived taste intensity, food intake, body weight, body composition, glucose homeostasis and sweet liker type. The study sample will consist of 180 subjects. Enrolled participants will be distributed into three intervention groups; regular dietary sweetness exposure (n=60); low dietary sweetness exposure (n=60); and high dietary sweetness exposure (n =60). The intervention is semi-controlled for a period of six months. Preference and perceived taste intensity of a series of familiar and unfamiliar foods will be assessed at baseline (Day 0), during the intervention (Month 1, Month 3, Month 6) and in the follow-up period (Month 7, Month 10). Furthermore, outcomes such as observed food choice and intake during a test meal, reported food preferences, reported food cravings, sweet-liker type, glucose homeostasis, body weight, body composition and biomarkers related to diabetes and cardiovascular disease will be assessed as well.
Evidence supporting sweetness preference alterations via variations in dietary sweetness exposure is limited. Most studies investigating this focused only on specific sweet elements in the diet, (e.g. beverages; mono- and disaccharides; high-energy dense snacks) instead of sweetness in the diet as a whole. Furthermore, there is no clear evidence about the relation between dietary sweetness exposure and weight gain. Therefore, longer term, sufficiently-powered studies with a 'whole diet' approach are needed to address the question whether sweet preferences can be altered (suppressed or stimulated) by variations in sweetness exposure. It is important to answer this question so that dietary recommendations can be scientifically tailored accordingly. The present study will provide breakthrough evidence about the flexibility/adaptability of sweetness preferences, in terms of effect sizes and direction, duration of effects, and impact on dietary intake, glucose homeostasis and body weight. This information is particularly relevant for product development by food industries in the context of reformulation strategies, and for governments to base their dietary guidelines upon.
The primary study objective is to assess the effect of a 6-month low, regular and high dietary sweetness exposure on sweetness preference in a series of familiar and unfamiliar foods. Preference will be assessed in both familiar and unfamiliar foods since, preferences in familiar, commonly eaten foods might by harder to change compared to those for unfamiliar foods, because there is no consumer-expected sweetness level associated with unfamiliar foods. The secondary objective is to assess the effect of a 6-month low, regular and high dietary sweetness exposure on sweetness perception, food choice and intake during a test meal, dietary taste patterns, taste preferences, food cravings, sweet-liker type, glucose homeostasis, biomarkers related to cardiovascular disease (CVD) and diabetes, body weight and body composition. Participants will be matched on age, gender, BMI and sweet liker status and randomly allocated to one of the three intervention arms: (1) regular dietary sweetness exposure (25-30 percent daily energy from sweet foods) (control) (n=60); (2) low dietary sweetness exposure (10-15 percent daily energy from sweet foods) (n=60); and (3) high dietary sweetness exposure (40-45 percent daily energy from sweet foods) (n=60). The intervention is semi-controlled, meaning that 50 percent of the foods will be provided to participants. Foods are offered ad libitum, on a weekly basis and macronutrient composition of the offered foods is similar in energy and macronutrient composition, that is fat, protein, carbohydrates and fibres, but different in sweetness. New methodology of our group enables us to assess sweetness exposure within a diet, by profiling foods based on six taste clusters (neutral; salt, umami & fat; sweet and fat; sweet and sour; fat; bitter).
Preference and perceived taste intensity will be assessed during hedonic and sensory evaluation of eight foods; three sweet familiar, three sweet unfamiliar and two salty familiar ones. Foods are solid, semi-solid and liquid. Furthermore, observed food choice and intake during test meals, reported food preferences, reported food cravings, sweet-liker type, glucose homeostasis, body weight, body composition and biomarkers related to diabetes and cardiovascular disease will be assessed. Outcomes will be assessed several times; at baseline (Month 0), during the intervention Month 1, Month 3, Month 6 and in the follow up period (Month 7, Month 10). Compliance will be assessed with 24-hour urine sample and dietary assessment methods (24-hour recalls).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regular dietary sweetness exposure - Control | Active Comparator | Regular dietary sweetness exposure (RSE) - The RSE group consumes a diet with 25 - 30 % energy from sweet tasting foods, for 6 months. |
|
| Low dietary sweetness exposure - Experimental | Experimental | Low dietary sweetness exposure (LSE) - The LSE group consumes a diet with 10 - 15 % energy from sweet tasting foods, for 6 months. |
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| High dietary sweetness exposure - Experimental | Experimental | High dietary sweetness exposure (HSE) - The HSE group consumes a diet with 40 - 45 % energy from sweet tasting foods, for 6 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary intervention | Other | Varying the exposure to sweetness via diet manipulation. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in preference score. | Measured during preference testing, using Ranking on a scale methodology (scale anchored at 0: Dislike extremely; 50: Neither dislike or like; 100: Like extremely) in a series of test foods. | from month 0 to month 6. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in preference score. | Measured during preference testing, using Ranking on a scale methodology (scale anchored at 0: Dislike extremely; 50: Neither dislike or like; 100: Like extremely) in a series of test foods. | from month 0 to month 1, 3, 7 ad 10. |
| Difference in mean liking scores between familiar and unfamiliar foods. |
| Measure | Description | Time Frame |
|---|---|---|
| Gender. | Self-reported. | Assessed at month 0. |
| Height. | Measured with a stadiometer. | Assessed at month 0. |
Inclusion Criteria:
Exclusion Criteria:
Specific criteria for withdrawal:
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| Name | Affiliation | Role |
|---|---|---|
| Kees de Graaf | WU | Study Chair |
| Monica Mars | WU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Human Nutrition, Wageningen University | Wageningen | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36627602 | Background | Cad EM, Tang CS, de Jong HBT, Mars M, Appleton KM, de Graaf K. Study protocol of the sweet tooth study, randomized controlled trial with partial food provision on the effect of low, regular and high dietary sweetness exposure on sweetness preferences in Dutch adults. BMC Public Health. 2023 Jan 11;23(1):77. doi: 10.1186/s12889-022-14946-4. | |
| 41485871 |
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Individual participant data that underline the results reported in an article after de-identification will be shared.
Immediately following the publication. No end date.
Anyone who wishes to access the data. Individuals who wish to use the data for secondary analysis must contact corresponding authors of respective/specific publications for their approval. They must also reference the source of the data to provide appropriate credit to those who generated it and allow searching for the studies it has supported.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 7, 2024 | Mar 27, 2024 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D005518 | Food Preferences |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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| OTHER |
| Arla Foods | INDUSTRY |
| Cargill | INDUSTRY |
| Firmenich, Switzerland | UNKNOWN |
| International Sweeteners Association | UNKNOWN |
| SinoSweet, China | UNKNOWN |
| Cosun Nutrition Center, Netherlands | UNKNOWN |
| Unilever R&D | INDUSTRY |
Randomised controlled intervention study
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Measured during preference testing, using Ranking on a scale methodology (scale anchored at 0: Dislike extremely; 50: Neither dislike or like; 100: Like extremely) in a series of test foods. |
| Measured at 0, 1, 3, 6, 7 and 10 months. |
| Change in sensory intensity scores. | Measured during sensory testing, using 100-unit Visual analogue scale (VAS), (anchored at 0: not sweet/salty at all; 100: Extremely sweet/salty) in a series of test foods. | Measured at 0, 1, 3, 6, 7 and 10 months. |
| Change in energy intake. | Measured during ad-libitum test meal in kcal. | Measured at 0, 1, 3, 6, 7 and 10 months. |
| Change in energy intake. | Measured during ad-libitum test meal in kJ. | Measured at 0, 1, 3, 6, 7 and 10 months. |
| Proportion of eaten sweet foods vs. foods from other taste modalities. | Measured during ad-libitum test meal in proportions. | Measured at 0, 1, 3, 6, 7 and 10 months |
| Sweet-liker status score. | Measured on a 100-unit VAS scale (anchored at 0: Dislike; 100: Like). | Measured at 0, 1, 3, 6, 7 and 10 months. |
| Food craving questionnaire scores. | Measured using the Control of eating questionnaire (CoEQ) | Measured at 0, 1, 3, 6, 7 and 10 months. |
| Taste preference questionnaire scores. | Measured using Taste Preference questionnaire (PrefQuest). | Measured at 0, 1, 3, 6, 7 and 10 months. |
| Dietary taste patterns. | Measured with the Taste food frequency questionnaire in frequency. | Measured at 0, 1, 3, 6, 7 and 10 months. |
| Dietary taste patterns. | Measured with the Taste food frequency questionnaire in % of energy coming from each taste cluster. | Measured at 0, 1, 3, 6, 7 and 10 months. |
| Dietary taste patterns. | Measured with the Taste food frequency questionnaire in % of food weight coming from each taste cluster. | Measured at 0, 1, 3, 6, 7 and 10 months. |
| Body weight. | Measured with a weighing scale in kg. | Measured at 0, 1, 2, 3, 4, 5, 6, 7 and 10 months. |
| Waist-to-hip ratio. | Measured using a stretch-resistant tape. | Measured at 0, 1, 3, 6, 7 and 10 months. |
| % of body fat mass and lean body mass (fat free mass). | Measured with a dual energy x-ray absorptiometry (DEXA). | Measured at 0, 6 and 10 months. |
| Variation in interstitial glucose levels. | Measured with glucose monitoring sensor (only measured in a subgroup, of 60 subjects, 20 per intervention arm). | Measured at 0, 6 and 10 months. |
| Change in fasting glucose, insulin, total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglycerides levels in blood. | Measured in blood in mmol/L. | Measured at 0, 1, 3, 6, 7 and 10 months. |
| Adverse events. | Self-reported and monitored. | Measured at 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months. |
| Concentration of biomarkers in urine related to sugar, low and no calorie sweeteners, protein and salt intake. | Measured in urine in mg/d. | Measured at 0, 1, 3, 6, 7 and 10 months. |
| Intake levels of foods, food groups and macronutrients. | Measured with 24-hour recalls, in kcal/day. | Measured at 0, 1, 2, 3, 4, 5, 6, 7 and 10 months. |
| Intake levels of foods, food groups and macronutrients. | Measured with 24-hour recalls, in kJ/day. | Measured at 0, 1, 2, 3, 4, 5, 6, 7 and 10 months. |
| Intake levels of foods, food groups and macronutrients. | Measured with 24-hour recalls, in g/day. | Measured at 0, 1, 2, 3, 4, 5, 6, 7 and 10 months. |
| Physical activity level. | Measured with the Short Questionnaire to Assess Health enhancing physical activity (SQUASH). | Measured at 0, 1, 3, 6, 7 and 10 months. |
| Polymorphisms in the genes related to the sweet taste perception. | Genes will be extracted from collected blood samples. | Assessed at month 0. |
| Age. | Self-reported. | Assessed at month 0. |
| Medicine usage. | Number and type of medicine used, self-reported. | Assessed at month 0. |
| Cad EM, Mars M, Pretorius L, van der Kruijssen M, Tang CS, de Jong HB, Balvers M, Appleton KM, de Graaf K. The Sweet Tooth Trial: A Parallel Randomized Controlled Trial Investigating the Effects of A 6-Month Low, Regular, or High Dietary Sweet Taste Exposure on Sweet Taste Liking, and Various Outcomes Related to Food Intake and Weight Status. Am J Clin Nutr. 2026 Jan;123(1):101073. doi: 10.1016/j.ajcnut.2025.09.041. Epub 2025 Nov 27. |