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CompletedNCT03427658Updated May 16, 2024Results posted

Repeated Sweet Consumption and Subsequent Sweet Food Preferences and Intake

An interventional study of 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 2024-05-16.

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

Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study will assess the impact of repeated sweet versus non-sweet food consumption on subsequent sweet and non-sweet food preferences and intakes

Read the 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.

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 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.

04

Study design

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

Study arms

  • 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.

    Behavioral: 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.

    Behavioral: Sweet food consumption

Interventions

  • BehavioralSweet food consumption

    Comparison of the impacts of sweet and non-sweet food consumption

05

What researchers measure

Primary outcomes

  1. Food Preferences

    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.

    Time frame: Change from Baseline to 1 week

  2. Food Intake

    Amount of sweet and non-sweet foods consumed during breakfast and lunch. Measures are made of grams of each sweet food consumed.

    Time frame: Change from Baseline to 1 week

Secondary outcomes

  1. Hunger Ratings

    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.

    Time frame: Change from Baseline to 1 week

06

Results

Posted May 16, 2024

Participant flow

Participant flow — Overall Study
MilestoneIncrease Sweet Food ConsumptionDecrease Sweet Food Consumption
Started2115
Completed2115
Not completed00

Outcome measures

PrimaryFood Preferences

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.

Time frame:
Change from Baseline to 1 week
Reported as:
Mean · units on a scale
Food Preferences
units on a scaleIncrease Sweet Food ConsumptionDecrease Sweet Food Consumption
Food Preferences7 ± 191 ± 13
PrimaryFood Intake

Amount of sweet and non-sweet foods consumed during breakfast and lunch. Measures are made of grams of each sweet food consumed.

Time frame:
Change from Baseline to 1 week
Reported as:
Mean · grams sweet food
Food Intake
grams sweet foodIncrease Sweet Food ConsumptionDecrease Sweet Food Consumption
Food Intake-24 ± 189-15 ± 183
SecondaryHunger Ratings

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.

Time frame:
Change from Baseline to 1 week
Reported as:
Mean · units on a scale
Hunger Ratings
units on a scaleIncrease Sweet Food ConsumptionDecrease Sweet Food Consumption
Hunger Ratings7 ± 28-2 ± 35

Adverse events

Collected over 1 week. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Increase Sweet Food Consumption0/21 (0%)0/21 (0%)0/21 (0%)
Decrease Sweet Food Consumption0/15 (0%)0/15 (0%)0/15 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Increase Sweet Food ConsumptionDecrease Sweet Food ConsumptionTotal
Mean21.0 ± 1.021.3 ± 0.821.1 ± 0.9
Sex: Female, Male
Sex: Female, Male(Participants)Increase Sweet Food ConsumptionDecrease Sweet Food ConsumptionTotal
Female15924
Male6612
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Increase Sweet Food ConsumptionDecrease Sweet Food ConsumptionTotal
Count of participants——0
Region of Enrollment
Region of Enrollment(participants)Increase Sweet Food ConsumptionDecrease Sweet Food ConsumptionTotal
United Kingdom211536
07

Study locations

1 site
  • University of Bristol
    Bristol, BS8 1TN, United Kingdom
08

References and documents

Study documents

  • Protocol and statistical analysis plan · May 3, 2024

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
NCT03427658
Lead sponsor
Bournemouth University
Collaborators
University of Bristol
Responsible party
Sponsor
First posted
Feb 9, 2018
Start date
Feb 12, 2018
Primary completion
Aug 1, 2019
Completion
Aug 30, 2019
Results posted
May 16, 2024
Last update
May 16, 2024

Study contacts

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

Oversight

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

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This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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