Clinical trial NCT05672017: Sweet Consumption and Subsequent Sweet Food Preferences and Intakes
Official title: Sweet Consumption and Subsequent Sweet Food Preferences and Intakes
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Dietary Behaviour
Lead sponsor: Bournemouth University
Sponsor class: OTHER
First posted: 2023-01-05
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will assess the effects of repeated sweet versus non-sweet food consumption on subsequent sweet and non-sweet food preferences and intakes.

Detailed description: Participants will be randomized to receive instructions to either increase, decrease or make no change to 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 a taste test at each assessment time, where six different foods will be rated. Sweet and non-sweet food consumption will also be measured at a subsequent breakfast at the assessment time. Buffet meals composed of sweet and non-sweet foods suitable for consumption at breakfast will be provided ad-libitum.

A subset of participants (selected at random) (10 participants randomized to increase sweet food consumption and 10 participants randomized to decrease sweet food consumption) will also be assessed via MRI and fMRI scanning to investigate brain structure and functional connectivity.

Eligibility criteria: Inclusion Criteria:

1. aged 18-65 years;
2. habitually consume breakfast;
3. able to provide consent and complete all study materials;
4. able to attend Bournemouth University for testing.

Exclusion criteria:

1. individuals who are pregnant or breastfeeding;
2. underweight (BMI \<18.5);
3. have pre-existing clinical conditions such as diabetes mellitus, eating disorders, Crohn's disease and other illness's leading to participants receiving external nutritional advice and dietary restrictions;
4. have pre-existing medical conditions affecting swallow ability, taste and smell perception;
5. currently or within 3 months of starting the study are following a specific dietary programme (e.g.: Slimming World);
6. current smokers or have smoked within 3 months of the study start date.

Primary outcomes:
measure: Sweet food preferences
timeFrame: Baseline to week 1
measure: Sweet food choices
timeFrame: Baseline to week 1
Secondary outcomes:
measure: Hunger and Thirst
timeFrame: Baseline to week 1
measure: Sweet food perceptions
timeFrame: Baseline to week 1
measure: MRI static brain scan (subset of participants only)
timeFrame: Baseline to week 1
measure: fMRI composite functional brain scan (subset of participants only)
timeFrame: Baseline to week 1
Other outcomes:
Locations:
city: Bournemouth
country: United Kingdom
facility: Bournemouth University
state: US And Canada Only
Study officials:
affiliation: Bournemouth University
name: Katherine M Appleton
role: PRINCIPAL_INVESTIGATOR
References:
citation: This project is associated with Clinical Trails Registration: NCT03427658