- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03427658
Repeated Sweet Consumption and Subsequent Sweet Food Preferences and Intake
May 8, 2024 updated by: Bournemouth University
Impact of Repeated Sweet and Non-sweet Food Consumption on Subsequent Sweet Food Preferences and Intake
This study will assess the impact of repeated sweet versus non-sweet food 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 instructions to either increase or decrease 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 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.
Study Type
Interventional
Enrollment (Actual)
36
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
-
-
-
Bristol, United Kingdom, BS8 1TN
- University of Bristol
-
-
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
Description
Inclusion Criteria:
- No known food allergy
- No known taste or appetite allergies
- Non-smokers
- Do not habitually consume exclusively / almost exclusively a sweet or non-sweet diet
- Able to provide consent and complete all study measures
Race / ethnicity will not be requested.
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: Increase sweet food consumption
Participants are asked to increase their consumption of sweet foods throughout their diet.
Participants will be supported through an individual dietary interview where sweet foods will be highlighted and additional sweet food consumption recommended.
|
Comparison of the impacts of sweet and non-sweet food consumption
|
|
Active Comparator: Decrease sweet food consumption
Participants are asked to decrease their consumption of sweet foods throughout their diet.
Participants will be supported through an individual dietary interview where sweet foods will be highlighted and substitutions for sweet food consumption will be recommended.
|
Comparison of the impacts of sweet and non-sweet food consumption
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Food Preferences
Time Frame: Change from Baseline to 1 week
|
Ratings of three sweet and three non-sweet foods during a taste test (two tests).
Measures are made on a visual analogue scale from 0 (not at all) to 100 (extremely), where higher scores denote higher preferences.
|
Change from Baseline to 1 week
|
|
Food Intake
Time Frame: Change from Baseline to 1 week
|
Amount of sweet and non-sweet foods consumed during breakfast and lunch.
Measures are made of grams of each sweet food consumed.
|
Change from Baseline to 1 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hunger Ratings
Time Frame: Change from Baseline to 1 week
|
Ratings of subjective perceptions (two meals).
Measures are made on a visual analogue scale from 0 (not at all) to 100 (extremely), where higher scores denote higher hunger.
|
Change from Baseline to 1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Peter Rogers, PhD, University of Bristol
- Principal Investigator: Katherine Appleton, PhD, Bournemouth University, UK
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 12, 2018
Primary Completion (Actual)
August 1, 2019
Study Completion (Actual)
August 30, 2019
Study Registration Dates
First Submitted
February 1, 2018
First Submitted That Met QC Criteria
February 8, 2018
First Posted (Actual)
February 9, 2018
Study Record Updates
Last Update Posted (Actual)
May 16, 2024
Last Update Submitted That Met QC Criteria
May 8, 2024
Last Verified
January 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PRKA2018
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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