NCT04497974

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2019

Completed
8 months until next milestone

First Posted

Study publicly available on registry

August 4, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

October 20, 2020

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2024

Completed
Last Updated

June 13, 2024

Status Verified

June 1, 2024

Enrollment Period

3.6 years

First QC Date

December 16, 2019

Last Update Submit

June 10, 2024

Conditions

Keywords

sweetnesspreferences

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (22)

  • Change in preference score.

    from month 0 to month 1, 3, 7 ad 10.

  • Difference in mean liking scores between familiar and unfamiliar foods.

    Measured at 0, 1, 3, 6, 7 and 10 months.

  • Change in sensory intensity scores.

    Measured at 0, 1, 3, 6, 7 and 10 months.

  • Change in energy intake.

    Measured at 0, 1, 3, 6, 7 and 10 months.

  • Change in energy intake.

    Measured at 0, 1, 3, 6, 7 and 10 months.

  • +17 more secondary outcomes

Other Outcomes (6)

  • Gender.

    Assessed at month 0.

  • Height.

    Assessed at month 0.

  • Physical activity level.

    Measured at 0, 1, 3, 6, 7 and 10 months.

  • +3 more other outcomes

Study Arms (3)

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.

Other: Dietary intervention

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.

Other: Dietary intervention

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.

Other: Dietary intervention

Interventions

Varying the exposure to sweetness via diet manipulation.

High dietary sweetness exposure - ExperimentalLow dietary sweetness exposure - ExperimentalRegular dietary sweetness exposure - Control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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:
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Human Nutrition, Wageningen University

Wageningen, Netherlands

Location

Related Publications (2)

  • 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.

    PMID: 36627602BACKGROUND
  • 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.

MeSH Terms

Conditions

Food Preferences

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

Study Officials

  • Kees de Graaf

    WU

    STUDY CHAIR
  • Monica Mars

    WU

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Randomised controlled intervention study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor dr.ir Monica Mars

Study Record Dates

First Submitted

December 16, 2019

First Posted

August 4, 2020

Study Start

October 20, 2020

Primary Completion

June 5, 2024

Study Completion

June 5, 2024

Last Updated

June 13, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will share

Individual participant data that underline the results reported in an article after de-identification will be shared.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
Immediately following the publication. No end date.
Access Criteria
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.

Locations