NCT04633681

Brief Summary

This study aims to evaluate the acute (1-day) and repeated (2-week) effects of combinations of Sweeteners \& Sweetness Enhancer blends on metabolic, sensory, neuro-behavioural and microbiota-mediated processes involved in satiety, consumer preferences and health.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
175

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable

Geographic Reach
4 countries

5 active sites

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

October 30, 2020

Completed
19 days until next milestone

First Posted

Study publicly available on registry

November 18, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2023

Completed
Last Updated

August 12, 2024

Status Verified

August 1, 2024

Enrollment Period

2.5 years

First QC Date

October 30, 2020

Last Update Submit

August 9, 2024

Conditions

Eating Behavior

Keywords

appetitefood preferencessweetenerssweetness enhancers

Outcome Measures

Primary Outcomes (1)

  • Composite Appetite Sensations Incremental Area Under the Curve

    Incremental area under the curve (iAUC) for composite appetite sensations in response to each product. During each of the Clinical Investigation Days iAUC composite appetite will be measured 180 minutes post intake. The following sensations of appetite will be used in the composite measure: * hunger * fullness * desire to eat * prospective consumption Minimum value 0 Maximum value 100 Higher scores mean worse outcome

    Clinical Investigation Day 1, 2, 3, 4, 5, 6

Secondary Outcomes (12)

  • Leeds Food Preference Questionnaire (LFPQ) Explicit Liking

    Clinical Investigation Day 1, 2, 3, 4, 5, 6

  • Leeds Food Preference Questionnaire (LFPQ) Implicit Wanting

    Clinical Investigation Day 1, 2, 3, 4, 5, 6

  • Leeds Food Preference Questionnaire (LFPQ) Relative preference

    Clinical Investigation Day 1, 2, 3, 4, 5, 6

  • Leeds Food Preference Questionnaire (LFPQ) Explicit wanting

    Clinical Investigation Day 1, 2, 3, 4, 5, 6

  • Control of Eating Questionnaire (CoEQ): Craving Control

    Clinical Investigation Day 1, 2, 3, 4, 5, 6

  • +7 more secondary outcomes

Other Outcomes (39)

  • Body composition: fat mass (kg)

    Clinical Investigation Day 1, 2, 3, 4, 5, 6

  • Body composition: fat-free mass (kg)

    Clinical Investigation Day 1, 2, 3, 4, 5, 6

  • Body weight (kg)

    Fasting during each Clinical Investigation Day 1, 2, 3, 4, 5, 6

  • +36 more other outcomes

Study Arms (7)

Cake matrix

EXPERIMENTAL

3 phases of 2-week daily consumption of cake product containing 1) sucrose, 2) Neotame 1, 3) Stevia Reb M. Randomised cross-over with 2-week wash-out between phases.

Dietary Supplement: Sweetener and sweetness enhancer consumption

Biscuit matrix

EXPERIMENTAL

3 phases of 2-week daily consumption of biscuit product containing 1) sucrose, 2) Neotame 1, 3) Stevia Reb M. Randomised cross-over with 2-week wash-out between phases.

Dietary Supplement: Sweetener and sweetness enhancer consumption

Yoghurt matrix

EXPERIMENTAL

3 phases of 2-week daily consumption of yoghurt product containing 1) sucrose, 2) sweetener blend 1, 3) sweetener blend 2. Randomised cross-over with 2-week wash-out between phases.

Dietary Supplement: Sweetener and sweetness enhancer consumption

Chocolate matrix

EXPERIMENTAL

3 phases of 2-week daily consumption of chocolate product containing 1) sucrose, 2) sweetener blend 1, 3) sweetener blend 2. Randomised cross-over with 2-week wash-out between phases.

Dietary Supplement: Sweetener and sweetness enhancer consumption

Cereal matrix

EXPERIMENTAL

3 phases of 2-week daily consumption of cereal product containing 1) sucrose, 2) sweetener blend 1, 3) sweetener blend 2. Randomised cross-over with 2-week wash-out between phases.

Dietary Supplement: Sweetener and sweetness enhancer consumption

Universal Eating Monitor study

EXPERIMENTAL

A sub-group of the yoghurt matrix will be selected for assessment of eating rate and microstructure of feeding using Universal Eating Monitors.

Dietary Supplement: Sweetener and sweetness enhancer consumption

fMRI study

EXPERIMENTAL

A sub-group of the chocolate matrix will be selected for assessment of neural activation to images of food using fMRI.

Dietary Supplement: Sweetener and sweetness enhancer consumption

Interventions

Sweetener and sweetness enhancer consumptionDIETARY_SUPPLEMENT

Two-week consumption of combinations of different sweetener and sweetness enhancer blends in reformulated food products compared to sucrose containing product.

Biscuit matrixCake matrixCereal matrixChocolate matrixUniversal Eating Monitor studyYoghurt matrixfMRI study

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI: 25 to 35 kg/m2
  • Use of contraceptive methods or not planning to become pregnant for the duration of the study (women only)
  • Regular consumption of sugar-containing foods and willing to consume sugar and artificially-sweetened food products.
  • Liking of the intervention foods defined by a response of Yes for the product during the pre-screening interview and a score of 40% or above on the Liking Visual Analogue Scale for the sucrose-sweetened control product.
  • Able to participate on the Clinical Investigation Days during normal working hours.
  • Healthy as determined from the self-reported medical history or when a clinical condition exists, when this is considered to be irrelevant (i.e. not influencing study outcomes) for the study by the study medical doctor.
  • Consuming breakfast regularly (at least 5 days per week).
  • Able to understand and be willing to sign the informed consent form, and to follow all the study procedures and requirements.
  • Capacity to store at-home intervention quantity of intervention product

You may not qualify if:

  • Blood donation \< 3 month prior to study or for full duration of the study.
  • Food allergy, intolerance, restriction or avoidance of any of the study foods (e.g. veganism) or history of anaphylactic reaction to any food.
  • Likelihood for disordered eating defined as a score ≥20 on the Eating Attitudes Test.
  • Currently dieting to lose weight.
  • Having lost or gained \>4.5 kg in the last 3 months.
  • Smoking or having quit \<3 months prior to study.
  • Habitually consuming \>14 units/week of alcohol in women or \>21 units/week in men in the last 3 months.
  • Performing \>10 h of intense physical activity per week in the last 3 months.
  • Night or late shift work (ending later than 11 pm on a permanent basis). Rotational shift work allowed if can attend on days that do not follow a late/night shift.
  • Self-reported use of drugs of abuse within the previous 12 months.
  • Pregnancy, lactation (women only)
  • Persons who do not have access to either (mobile) phone or internet (this is necessary when being contacted by the study personnel during the study).
  • Insufficient communication in the national language.
  • Proven or suspected inability, physically or mentally, to comply with the procedures required by the study protocol as evaluated by the daily study manager, site-PI, PI or clinical responsible. This includes volunteers for which insufficient collaboration may be foreseen.
  • Subject's general condition contraindicates continuing in the study as evaluated by the daily study manager, site-PI, PI or responsible clinician.
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of Copenhagen

Copenhagen, Denmark

Location

CRNH-RA

Lyon, France

Location

University of Navarra

Pamplona, 31009, Spain

Location

University of Leeds

Leeds, West Yorkshire, LS2 9JT, United Kingdom

Location

University of Liverpool

Liverpool, United Kingdom

Location

Related Publications (1)

  • Gibbons C, O'Hara B, O'Connor D, Hardman C, Wilton M, Harrold JA, Almiron-Roig E, Navas-Carretero S, Hodgkins CE, Nazare JA, Alligier M, Martinez JA, Scott C, Kjolbaek L, Normand M, Rannou C, Blaak EE, Feskens E, Moshoyiannis H, Raben A, Halford JCG, Beaulieu K, Finlayson G. Acute and repeated impact of sweeteners and sweetness enhancers in solid and semi-solid foods on appetite: protocol for a multicentre, cross-over, RCT in people with overweight/obesity - the SWEET Project. BMJ Open. 2022 Dec 23;12(12):e063903. doi: 10.1136/bmjopen-2022-063903.

    PMID: 36564114DERIVED

MeSH Terms

Conditions

Feeding BehaviorFood Preferences

Interventions

Sweetening Agents

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Intervention Hierarchy (Ancestors)

Flavoring AgentsFood AdditivesFood IngredientsSpecialty Uses of ChemicalsChemical Actions and UsesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double blind study. Neither the participant nor the investigator will be aware of the coding of food products used in the study.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Double-blind, within-subjects, cross-over trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 30, 2020

First Posted

November 18, 2020

Study Start

April 1, 2021

Primary Completion

September 29, 2023

Study Completion

November 20, 2023

Last Updated

August 12, 2024

Record last verified: 2024-08

Locations

ES(1)DK(1)GB(2)FR(1)