Repeated Sweet Food ConsumptionNCT03442829
Repeated Sweet Breakfasts and Subsequent Sweet Food Preferences and Intakes
A study testing Sweet food consumption and Non-sweet food consumption in people with Repeated Sweet Food Consumption, run by Bournemouth University at 1 site in United Kingdom.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Repeated Sweet Food Consumption
- What is being tested?
- Sweet food consumption and Non-sweet food consumption
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Feb 2018to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- No known food allergy
- No known taste or appetite abnormalities
- Non-smoker
- Habitually eats breakfast
- Able to provide consent and complete all study measures
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Bournemouth University
Bournemouth, US and Canada Only, BH12 5BB
About this study
Official title: 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
Read the 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.
- Conditions
- Repeated Sweet Food Consumption
- Being tested
- Sweet food consumption, Non-sweet food consumption
- Keywords
- sweet taste, food preferences, food intake
- Medical subject headings
- Food Preferences
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sweet food consumptionBehavioural
Sweet food consumption at breakfast
Non-sweet food consumptionBehavioural
Non-sweet food consumption at breakfast
| Study group | Role | What they receive |
|---|---|---|
| Sweet food consumption | Experimental | 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. Receives: Behavioral: Sweet food consumption |
| Non-sweet food consumption | Active comparator | 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. Receives: Behavioral: Non-sweet food consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food Preferences
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.
Measured: 3 weeks from baseline
Food Intake
Amount of sweet and non-sweet foods consumed during breakfast on test days (days 0, 7 and 21, day 21 reported)
Measured: 3 weeks from baseline
Secondary outcomes (3)
Hunger Ratings
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.
Measured: 3 weeks from baseline
Food Preferences at Lunch
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.
Measured: 3 weeks from baseline
Food Intake at Lunch
Amount of sweet and non-sweet foods consumed during lunch on test days (days 0, 7 and 21, day 21 reported).
Measured: 3 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start23 Feb 2018
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Repeated Sweet Food ConsumptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bournemouth University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bristol
- Responsible party
- Sponsor
- Investigators
- Katherine Appleton, PhD, Principal investigator, Bournemouth University, UKPeter Rogers, PhD, Principal investigator, University of Bristol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03442829
- Sponsor's protocol ID
- KAPR2018
- Status last verified
- Sep 2020
- First submitted
- 1 Feb 2018
- Last updated
- 23 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Repeated Sweet Breakfasts on Subsequent Sweet Food Preferences and Intakes
- ClinicalTrials.gov ID
- NCT03442829
- Acronym / sponsor ID
- KAPR2018
- Conditions
- Repeated Sweet Food Consumption
- Keywords
- sweet taste, food preferences, food intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Bournemouth UniversityUniversity, hospital or other
- Collaborators
- University of Bristol
- Study start
- 23 Feb 2018 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 22 Feb 2018 (actual)
- Results
- Posted 27 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sweet food consumption | Experimental | Behavioral: Sweet food consumptionSweet 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. |
| Non-sweet food consumption | Active comparator | Behavioral: Non-sweet food consumptionNon-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- No known food allergy
- No known taste or appetite abnormalities
- Non-smoker
- Habitually eats breakfast
- Able to provide consent and complete all study measures
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sweet food consumptionSweet food consumption at breakfast | Behavioural | Sweet food consumption |
| Non-sweet food consumptionNon-sweet food consumption at breakfast | Behavioural | Non-sweet food consumption |
Primary outcome
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.
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 secondary outcomes
Hunger Ratings
Time frame: 3 weeks from baseline
Food Preferences at Lunch
Time frame: 3 weeks from baseline
Food Intake at Lunch
Time frame: 3 weeks from baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine Appleton, PhD principal investigator
Bournemouth University, UK
Peter Rogers, PhD principal investigator
University of Bristol
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sweet food consumption and Non-sweet food consumption in people with Repeated Sweet Food Consumption, run by Bournemouth University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Food Preferences (time frame: 3 weeks from baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2020.