- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05672017
Sweet Consumption and Subsequent Sweet Food Preferences and Intakes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Participants will be randomized to receive instructions to either increase, decrease or make no change to sweet food consumption for 6 days, and impacts on food preferences and intakes will be assessed at baseline and after 1 week. Preferences for sweet and non-sweet foods will be assessed during a taste test at each assessment time, where six different foods will be rated. Sweet and non-sweet food consumption will also be measured at a subsequent breakfast at the assessment time. Buffet meals composed of sweet and non-sweet foods suitable for consumption at breakfast will be provided ad-libitum.
A subset of participants (selected at random) (10 participants randomized to increase sweet food consumption and 10 participants randomized to decrease sweet food consumption) will also be assessed via MRI and fMRI scanning to investigate brain structure and functional connectivity.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
US And Canada Only
-
Bournemouth, US And Canada Only, United Kingdom, BH12 5BB
- Bournemouth University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- aged 18-65 years;
- habitually consume breakfast;
- able to provide consent and complete all study materials;
- able to attend Bournemouth University for testing.
Exclusion criteria:
- individuals who are pregnant or breastfeeding;
- underweight (BMI <18.5);
- have pre-existing clinical conditions such as diabetes mellitus, eating disorders, Crohn's disease and other illness's leading to participants receiving external nutritional advice and dietary restrictions;
- have pre-existing medical conditions affecting swallow ability, taste and smell perception;
- currently or within 3 months of starting the study are following a specific dietary programme (e.g.: Slimming World);
- current smokers or have smoked within 3 months of the study start date.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Dietary Instructions: Increase sweet food consumption
Participants are asked to increase their consumption of sweet foods throughout their diet.
Participants will be provided with clear instructions, where sweet foods will be highlighted and additional means of increasing sweet food consumption will be offered.
|
Dietary Instructions
|
|
Active Comparator: Dietary Instructions: Decrease sweet food consumption
Participants are asked to decrease their consumption of sweet foods throughout their diet.
Participants will be provided with clear instructions, where sweet foods will be highlighted and means of decreasing sweet food consumption will be offered.
|
Dietary Instructions
|
|
Placebo Comparator: Dietary Instructions: Usual Diet
Participants are asked to retain their consumption of sweet foods throughout their diet.
|
Dietary Instructions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sweet Food Preferences
Time Frame: Week 1
|
Preferences for various sweet foods/fluids, assessed using a taste test, where participants sample several sweet and non-sweet foods and rate them for pleasantness on a 100mm Visual Analogue Scale, from 0 to 100mm.
Higher scores signify stronger preferences
|
Week 1
|
|
Sweet Food Choices
Time Frame: Week 1
|
Selection of sweet foods/fluids at a given meal, assessed where participants can consume freely from a meal composed of sweet and non-sweet foods, and proportion of sweet foods consumed is measured as a percentage of weight consumed
|
Week 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hunger and Thirst
Time Frame: Week 1
|
Ratings of subjective perceptions, assessed using 100mm VAS from 0 (lower hunger) to 100 (higher hunger) mm
|
Week 1
|
|
Sweet Food Perceptions
Time Frame: Week 1
|
Perceptions for various sweet foods/fluids, assessed using a taste test, where participants sample several sweet and non-sweet foods and rate them for intensity on a 100mm Visual Analogue Scale from 0 to 100mm.
Higher scores signify stronger perceptions
|
Week 1
|
|
MRI Static Brain Scan (Subset of Participants Only)
Time Frame: Baseline to week 1
|
Static brain scan gained from a 3-Tesla Siemens Magnetom Lumina scanner (Siemens Healthcare, Erlangen, Germany), used to investigate brain structure, where the anatomical structure (e.g.
size, shape) of the brain, measured via surface area (mm squared), will be compared at baseline and week 1
|
Baseline to week 1
|
|
fMRI Composite Functional Brain Scan (Subset of Participants Only)
Time Frame: Baseline to week 1
|
Composite fMRI functional scan to investigate brain functionality and connectivity in response to a 10 min cognitive task, will be gained from a 3-Tesla Siemens Magnetom Lumina scanner (Siemens Healthcare, Erlangen, Germany), where patterns of activity will be measured using blood oxygenation level-dependent (BOLD) contrast whole-brain functional images, acquired using a T2-weighted gradient-echo Echo Planar Imaging (EPI) sequence and a 32-channel head coil during a 10 min cognitive task, and will be compared at baseline and week 1 (for full details of this methodology see Yankouskaya A, et al., Biology, 2023, 12, 211.)
|
Baseline to week 1
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Katherine M Appleton, Bournemouth University
Publications and helpful links
General Publications
- This project is associated with Clinical Trails Registration: NCT03427658
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Other Study ID Numbers
- AppletonRSFC2022
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
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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