- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03442829
Repeated Sweet Breakfasts and Subsequent Sweet Food Preferences and Intakes
September 1, 2020 updated by: Bournemouth University
Impact of Repeated Sweet Breakfasts on Subsequent Sweet Food Preferences and Intakes
This study will assess the impact of repeated sweet breakfast consumption versus repeated non-sweet breakfast consumption on subsequent sweet and non-sweet food preferences and intakes
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Participants will be randomized to receive either sweet or non-sweet breakfasts for three consecutive weeks, and impacts on food preferences and intakes will be assessed at baseline (day 0), after 1 week (day 7), and after three weeks (day 21).
Preferences for sweet and non-sweet foods will be assessed during two taste tests at each assessment time, where six different foods will be rated.
Sweet and non-sweet food consumption will also be measured at two meals at each assessment time - breakfast and lunch.
Identical buffet meals composed of sweet and non-sweet foods suitable for consumption at breakfast and lunch will be provided ad-libitum.
Intervention breakfasts will only be consumed on the days between test days.
Study Type
Interventional
Enrollment (Actual)
54
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
US And Canada Only
-
Bournemouth, US And Canada Only, United Kingdom, BH12 5BB
- Bournemouth University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- No known food allergy
- No known taste or appetite abnormalities
- Non-smoker
- Habitually eats breakfast
- Able to provide consent and complete all study measures
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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 |
|---|---|
|
Experimental: Sweet food consumption
Sweet breakfasts.
Participants are asked to consume a sweet breakfast every day for three weeks (excepting on three days when outcomes will be assessed (days 0, 7 and 21, day 21 reported).
All foods will be provided.
|
Sweet food consumption at breakfast
|
|
Active Comparator: Non-sweet food consumption
Non-sweet breakfasts.
Participants are asked to consume a non-sweet breakfast every day for three weeks (excepting on three days when outcomes will be assessed (days 0, 7 and 21, day 21 reported).
All foods will be provided.
|
Non-sweet food consumption at breakfast
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Food Preferences
Time Frame: 3 weeks from baseline
|
Ratings of three sweet and three non-sweet foods during a taste test at breakfast.
Ratings measured using 100mm VAS scales for different hedonic factors - pleasure, sweetness, desire to eat).
Scores range from 0-100 where 0=least and 100=greatest for each hedonic factor.
Assessments made on Day 0, 7 and 21, Day 21 reported.
|
3 weeks from baseline
|
|
Food Intake
Time Frame: 3 weeks from baseline
|
Amount of sweet and non-sweet foods consumed during breakfast on test days (days 0, 7 and 21, day 21 reported)
|
3 weeks from baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hunger Ratings
Time Frame: 3 weeks from baseline
|
Ratings of subjective perceptions (two meals).
Ratings measured using 100mm VAS scales for different subjective factors - hunger, thirst, fullness.
Scores range from 0-100 where 0=least and 100=greatest for each subjective factor.
Assessments made on Day 0, 7 and 21, Day 21 reported.
|
3 weeks from baseline
|
|
Food Preferences at Lunch
Time Frame: 3 weeks from baseline
|
Ratings of three sweet and three non-sweet foods during a taste test at lunch.
Measures are the same as those used at breakfast.
Ratings measured using 100mm VAS scales for different hedonic factors - pleasure, sweetness, desire to eat).
Scores range from 0-100 where 0=least and 100=greatest for each hedonic factor.
Assessments made on Day 0, 7 and 21, Day 21 reported.
|
3 weeks from baseline
|
|
Food Intake at Lunch
Time Frame: 3 weeks from baseline
|
Amount of sweet and non-sweet foods consumed during lunch on test days (days 0, 7 and 21, day 21 reported).
|
3 weeks from baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 23, 2018
Primary Completion (Actual)
March 31, 2020
Study Completion (Actual)
March 31, 2020
Study Registration Dates
First Submitted
February 1, 2018
First Submitted That Met QC Criteria
February 21, 2018
First Posted (Actual)
February 22, 2018
Study Record Updates
Last Update Posted (Actual)
September 23, 2020
Last Update Submitted That Met QC Criteria
September 1, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- KAPR2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
The full study protocol is currently available from the PI on reasonable request.
All generated data will be available from the PI, following completion and publication of the work on reasonable request.
IPD Sharing Time Frame
Data will be available following completion and publication of the study.
Data will be stored for ten years following publication of the work.
IPD Sharing Access Criteria
Direct contact and reasonable request of the PI.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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