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CompletedNCT03442829Updated Sep 23, 2020Results posted

Repeated Sweet Breakfasts and Subsequent Sweet Food Preferences and Intakes

An interventional study of Sweet food consumption and Non-sweet food consumption in Repeated Sweet Food Consumption, sponsored by Bournemouth University. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-23.

Sponsored by Bournemouth University · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Repeated Sweet Food Consumption

Keywords

  • sweet taste, food preferences, food intake
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
54 participants (actual)

Study arms

  • 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.

    Behavioral: Sweet food consumption

  • 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.

    Behavioral: Non-sweet food consumption

Interventions

  • BehavioralSweet food consumption

    Sweet food consumption at breakfast

  • BehavioralNon-sweet food consumption

    Non-sweet food consumption at breakfast

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 weeks from baseline

  2. Food Intake

    Amount of sweet and non-sweet foods consumed during breakfast on test days (days 0, 7 and 21, day 21 reported)

    Time frame: 3 weeks from baseline

Secondary outcomes

  1. 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.

    Time frame: 3 weeks from baseline

  2. 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.

    Time frame: 3 weeks from baseline

  3. 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).

    Time frame: 3 weeks from baseline

06

Results

Posted Aug 27, 2020

Participant flow

Participant flow — Overall Study
MilestoneSweet Food ConsumptionNon-sweet Food Consumption
Started2727
Completed2325
Not completed42
Withdrew: Scheduling clash31
Withdrew: Illness unrelated to study11

Outcome measures

PrimaryFood 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.

Time frame:
3 weeks from baseline
Reported as:
Mean · units on a scale
Food Preferences
units on a scaleSweet Food ConsumptionNon-sweet Food Consumption
Sweet foods73 ± 3.168 ± 4.0
Non-sweet foods54 ± 3.650 ± 3.8
PrimaryFood Intake

Amount of sweet and non-sweet foods consumed during breakfast on test days (days 0, 7 and 21, day 21 reported)

Time frame:
3 weeks from baseline
Reported as:
Mean · percentage of total food consumed
Food Intake
percentage of total food consumedSweet Food ConsumptionNon-sweet Food Consumption
Percent weight consumed from sweet foods28.5 ± 336 ± 4
Percent energy consumed from sweet foods37 ± 439 ± 4
SecondaryHunger 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.

Time frame:
3 weeks from baseline
Reported as:
Mean · units on a scale
Hunger Ratings
units on a scaleSweet Food ConsumptionNon-sweet Food Consumption
Hunger72 ± 1968 ± 24
Fullness15 ± 1120 ± 30
Thirst65 ± 3067 ± 27
SecondaryFood 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.

Time frame:
3 weeks from baseline
Reported as:
Mean · units on a scale
Food Preferences at Lunch
units on a scaleSweet Food ConsumptionNon-sweet Food Consumption
Sweet foods70 ± 1567 ± 21
Non-sweet foods54 ± 2152 ± 18
SecondaryFood Intake at Lunch

Amount of sweet and non-sweet foods consumed during lunch on test days (days 0, 7 and 21, day 21 reported).

Time frame:
3 weeks from baseline
Reported as:
Mean · percentage of total food consumed
Food Intake at Lunch
percentage of total food consumedSweet Food ConsumptionNon-sweet Food Consumption
Percent weight consumed from sweet foods27 ± 1732 ± 19
Percent energy consumed from sweet foods33 ± 1737 ± 22

Adverse events

Collected over 3 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Sweet Food Consumption0/27 (0%)0/27 (0%)0/27 (0%)
Non-sweet Food Consumption0/27 (0%)0/27 (0%)0/27 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Sweet Food ConsumptionNon-sweet Food ConsumptionTotal
Mean24.2 ± 7.023.5 ± 4.423.9 ± 5.8
Sex: Female, Male
Sex: Female, Male(Participants)Sweet Food ConsumptionNon-sweet Food ConsumptionTotal
Female181836
Male9918
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Sweet Food ConsumptionNon-sweet Food ConsumptionTotal
Count of participants——0
Region of Enrollment
Region of Enrollment(participants)Sweet Food ConsumptionNon-sweet Food ConsumptionTotal
United Kingdom272754
BMI
BMI(kg/m^2)Sweet Food ConsumptionNon-sweet Food ConsumptionTotal
Mean24.0 ± 3.923.2 ± 3.223.6 ± 3.5
07

Study locations

1 site
  • Bournemouth University
    Bournemouth, US And Canada Only BH12 5BB, United Kingdom
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Apr 1, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Sap

09

Registry details

Key details

Study ID
NCT03442829
Lead sponsor
Bournemouth University
Collaborators
University of Bristol
Responsible party
Sponsor
First posted
Feb 22, 2018
Start date
Feb 23, 2018
Primary completion
Mar 31, 2020
Completion
Mar 31, 2020
Results posted
Aug 27, 2020
Last update
Sep 23, 2020

Study contacts

Katherine Appleton, PhD
principal investigator · Bournemouth University, UK
Peter Rogers, PhD
principal investigator · University of Bristol

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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