Clinical trial NCT05932329: Reducing Free Sugar Intakes: A Role for Sweet Taste II
Official title: Reducing Free Sugar Intakes: A Role for Sweet Taste II
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Dietary Behaviour
Lead sponsor: Bournemouth University
Sponsor class: OTHER
First posted: 2023-07-06
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized intervention design
Primary purpose: PREVENTION

Brief summary: This randomised controlled trial aims to assess the effects of three different types of dietary advice for reducing free sugar intakes, on intakes of free sugar, in a sample of the UK population.

Detailed description: The primary objective of this randomised controlled trial is to assess the effects of three different types of dietary advice, for reducing total energy intakes (TEI) of free sugars. A total of 150 participants (age 18-65 years) consuming diets \>5% total energy intake from dietary free sugars will be recruited from across the Dorset region. All participants will be asked to reduce their free sugar intake to \<5% TEI, and to aid with this, they will be encouraged to reduce their intakes of specific foods identified as high in free sugars. Participants will also be advised to replace these foods with other foods dependent on their taste. Participants will be randomised to replace high sugar foods with: 1) foods that are low in sugars, but high in sweet taste; 2) food that are low in sugars, but high in other tastes; and 3) foods that are low in taste. The primary outcome will be changes in free sugar consumption from baseline to endpoint at week 4. Secondary outcomes will include change in: BMI; dietary profiles; sweetness preference; sweetness liking; food choices; low calorie sweetened food intakes and adherence levels at week 4.

Eligibility criteria: Inclusion Criteria:

1. aged 18-65 years;
2. able to provide consent and complete all study materials;
3. consuming \>5% of TEI from free sugars;
4. residing in the South of England, and 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 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: Free sugar intakes
timeFrame: Baseline to week 4
measure: Adherence
timeFrame: Baseline to week 4
Secondary outcomes:
measure: Dietary Intakes
timeFrame: Baseline to week 4
measure: Body weight
timeFrame: Baseline to week 4
measure: BMI
timeFrame: Baseline to week 4
measure: Waist circumference
timeFrame: Baseline to week 4
measure: Body fat percentage
timeFrame: Baseline to week 4
measure: Sweet food preferences
timeFrame: Baseline to week 4
measure: Sweet food perceptions
timeFrame: Baseline to week 4
measure: Sweet food intakes
timeFrame: Baseline to week 4
measure: Sweet food attitudes
timeFrame: Baseline to week 4
measure: Adverse events
timeFrame: Baseline to week 4
measure: Eating-based attitudes
timeFrame: Baseline to week 4
measure: Subjective Quality of Life
timeFrame: Baseline to week 4
measure: Barriers and facilitators to success
timeFrame: Baseline to week 4
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: