- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04497974
Sweet Tooth: Nature or Nurture? Role of Long-term Dietary Sweetness Exposure on Sweetness Preferences
Role of Long-term Dietary Sweetness Exposure on Sweetness Preferences
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Eva Marija Cad, MSc
- Phone Number: +31317488077
- Email: eva.cad@wur.nl
Study Locations
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Wageningen, Netherlands
- Department of Human Nutrition, Wageningen University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Good general health;
- Age 18 - 65 years;
- Body mass index 18.5 - 30 kg/m2;
- Having normal taste ability (assessed with taste strips test);
- Having normal glucose levels in blood (assessed with a finger prick);
- Able to provide informed consent;
- Able to attend Wageningen University, as required for testing.
Exclusion Criteria:
- Diagnosed with diabetes currently or in the past;
- Has been notified to have insulin resistance currently or in the past;
- Diagnosed with endocrine diseases or other metabolic diseases that influence metabolism;
- Diagnosed with eating disorders;
- Diagnosed with taste or smell disorder;
- Pregnant or lactating during the study intervention;
- Gain or loss of more than 3 kg in the last three months prior to study entry;
- Suffering from lack of appetite (self-report);
- Use of medication that may influence study results; such as medication that may affect blood sugar;
- Having a food allergy or/and food intolerance for foods used in the preference testing (e.g. lactose intolerance, celiac disease, egg allergy);
- Consumes more than 14 glasses of alcohol per week;
- Use of soft or hard drugs (e.g. cannabis);
- Student or personnel of Nutrition and Health at Wageningen University;
- Participating in another study/studies or planning to participate in another study.
Specific criteria for withdrawal:
- Pregnancy;
- Weight change of 4 kg or more. In a case of systematic weight change - a subject has gained or lost 4 kg or more at the 3-month period, he/she will be excluded from the study (stop criterion).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Regular dietary sweetness exposure - Control
Regular dietary sweetness exposure (RSE) - The RSE group consumes a diet with 25 - 30 % energy from sweet tasting foods, for 6 months.
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Varying the exposure to sweetness via diet manipulation.
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Experimental: Low dietary sweetness exposure - 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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Varying the exposure to sweetness via diet manipulation.
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Experimental: High dietary sweetness exposure - 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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Varying the exposure to sweetness via diet manipulation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in preference score.
Time Frame: from month 0 to month 6.
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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.
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from month 0 to month 6.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in preference score.
Time Frame: from month 0 to month 1, 3, 7 ad 10.
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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.
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from month 0 to month 1, 3, 7 ad 10.
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Difference in mean liking scores between familiar and unfamiliar foods.
Time Frame: Measured at 0, 1, 3, 6, 7 and 10 months.
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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.
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Measured at 0, 1, 3, 6, 7 and 10 months.
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Change in sensory intensity scores.
Time Frame: Measured at 0, 1, 3, 6, 7 and 10 months.
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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.
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Measured at 0, 1, 3, 6, 7 and 10 months.
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Change in energy intake.
Time Frame: Measured at 0, 1, 3, 6, 7 and 10 months.
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Measured during ad-libitum test meal in kcal.
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Measured at 0, 1, 3, 6, 7 and 10 months.
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Change in energy intake.
Time Frame: Measured at 0, 1, 3, 6, 7 and 10 months.
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Measured during ad-libitum test meal in kJ.
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Measured at 0, 1, 3, 6, 7 and 10 months.
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Proportion of eaten sweet foods vs. foods from other taste modalities.
Time Frame: Measured at 0, 1, 3, 6, 7 and 10 months
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Measured during ad-libitum test meal in proportions.
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Measured at 0, 1, 3, 6, 7 and 10 months
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Sweet-liker status score.
Time Frame: Measured at 0, 1, 3, 6, 7 and 10 months.
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Measured on a 100-unit VAS scale (anchored at 0: Dislike; 100: Like).
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Measured at 0, 1, 3, 6, 7 and 10 months.
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Food craving questionnaire scores.
Time Frame: Measured at 0, 1, 3, 6, 7 and 10 months.
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Measured using the Control of eating questionnaire (CoEQ)
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Measured at 0, 1, 3, 6, 7 and 10 months.
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Taste preference questionnaire scores.
Time Frame: Measured at 0, 1, 3, 6, 7 and 10 months.
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Measured using Taste Preference questionnaire (PrefQuest).
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Measured at 0, 1, 3, 6, 7 and 10 months.
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Dietary taste patterns.
Time Frame: Measured at 0, 1, 3, 6, 7 and 10 months.
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Measured with the Taste food frequency questionnaire in frequency.
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Measured at 0, 1, 3, 6, 7 and 10 months.
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Dietary taste patterns.
Time Frame: Measured at 0, 1, 3, 6, 7 and 10 months.
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Measured with the Taste food frequency questionnaire in % of energy coming from each taste cluster.
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Measured at 0, 1, 3, 6, 7 and 10 months.
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Dietary taste patterns.
Time Frame: Measured at 0, 1, 3, 6, 7 and 10 months.
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Measured with the Taste food frequency questionnaire in % of food weight coming from each taste cluster.
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Measured at 0, 1, 3, 6, 7 and 10 months.
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Body weight.
Time Frame: Measured at 0, 1, 2, 3, 4, 5, 6, 7 and 10 months.
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Measured with a weighing scale in kg.
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Measured at 0, 1, 2, 3, 4, 5, 6, 7 and 10 months.
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Waist-to-hip ratio.
Time Frame: Measured at 0, 1, 3, 6, 7 and 10 months.
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Measured using a stretch-resistant tape.
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Measured at 0, 1, 3, 6, 7 and 10 months.
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% of body fat mass and lean body mass (fat free mass).
Time Frame: Measured at 0, 6 and 10 months.
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Measured with a dual energy x-ray absorptiometry (DEXA).
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Measured at 0, 6 and 10 months.
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Variation in interstitial glucose levels.
Time Frame: Measured at 0, 6 and 10 months.
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Measured with glucose monitoring sensor (only measured in a subgroup, of 60 subjects, 20 per intervention arm).
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Measured at 0, 6 and 10 months.
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Change in fasting glucose, insulin, total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglycerides levels in blood.
Time Frame: Measured at 0, 1, 3, 6, 7 and 10 months.
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Measured in blood in mmol/L.
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Measured at 0, 1, 3, 6, 7 and 10 months.
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Adverse events.
Time Frame: Measured at 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months.
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Self-reported and monitored.
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Measured at 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months.
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Concentration of biomarkers in urine related to sugar, low and no calorie sweeteners, protein and salt intake.
Time Frame: Measured at 0, 1, 3, 6, 7 and 10 months.
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Measured in urine in mg/d.
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Measured at 0, 1, 3, 6, 7 and 10 months.
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Intake levels of foods, food groups and macronutrients.
Time Frame: Measured at 0, 1, 2, 3, 4, 5, 6, 7 and 10 months.
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Measured with 24-hour recalls, in kcal/day.
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Measured at 0, 1, 2, 3, 4, 5, 6, 7 and 10 months.
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Intake levels of foods, food groups and macronutrients.
Time Frame: Measured at 0, 1, 2, 3, 4, 5, 6, 7 and 10 months.
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Measured with 24-hour recalls, in kJ/day.
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Measured at 0, 1, 2, 3, 4, 5, 6, 7 and 10 months.
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Intake levels of foods, food groups and macronutrients.
Time Frame: Measured at 0, 1, 2, 3, 4, 5, 6, 7 and 10 months.
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Measured with 24-hour recalls, in g/day.
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Measured at 0, 1, 2, 3, 4, 5, 6, 7 and 10 months.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gender.
Time Frame: Assessed at month 0.
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Self-reported.
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Assessed at month 0.
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Height.
Time Frame: Assessed at month 0.
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Measured with a stadiometer.
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Assessed at month 0.
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Physical activity level.
Time Frame: Measured at 0, 1, 3, 6, 7 and 10 months.
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Measured with the Short Questionnaire to Assess Health enhancing physical activity (SQUASH).
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Measured at 0, 1, 3, 6, 7 and 10 months.
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Polymorphisms in the genes related to the sweet taste perception.
Time Frame: Assessed at month 0.
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Genes will be extracted from collected blood samples.
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Assessed at month 0.
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Age.
Time Frame: Assessed at month 0.
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Self-reported.
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Assessed at month 0.
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Medicine usage.
Time Frame: Assessed at month 0.
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Number and type of medicine used, self-reported.
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Assessed at month 0.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Kees de Graaf, WU
- Principal Investigator: Monica Mars, WU
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- NL72134.081.19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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