Clinical trial NCT04816955: Dietary Recommendations for Reducing Free Sugar Intakes
Official title: Dietary Recommendations for Reducing Free Sugar Intakes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Recommendations
Keywords: free sugars
dietary intake
dietary recommendations
Lead sponsor: Bournemouth University
Sponsor class: OTHER
First posted: 2021-03-25
Enrollment: 242
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: TREATMENT

Brief summary: This randomised controlled trial aims to assess the impacts of the current recommendations by Public Health England for reducing free sugar intakes, on total energy intakes of free sugar in a sample of the UK population.

Detailed description: The primary objective of this randomised control trial is to assess the impacts of Public Health England's (PHE) current free sugar reducing advice, for reducing total energy intakes (TEI) of free sugar. A total of 240 participants (age 18-65years) consuming diets \>5% total energy intake from dietary free sugars will be recruited from across the Dorset region. Participants to be randomly assigned into the following recommendation interventions groups: 1) Reduce free sugar intake to \<5% TEI (nutrient-based recommendations); 2) Reduce free sugar intake to \<5% TEI, via reducing intake of specific foods identified as high in free sugars (nutrient- + food-based recommendations); 3) Reduce free sugar intake to \<5% TEI, via reducing intake of specific foods identified as high in free sugars and replace/swap with low sugar versions (nutrient- + food-based recommendations with swaps); and 4) Control Group. The primary outcome will be changes in free sugar consumption from baseline to endpoint at week 12. Secondary outcomes include change in: BMI; dietary profiles; sweetness preference; sweetness liking; food choices; low calorie sweetener intakes and adherence levels.

Eligibility criteria: Inclusion Criteria:

* aged 18-65 years;
* able to provide consent and complete all study materials;
* consuming \>5% of TEI from free sugars; and
* residing in the South of England.

Exclusion criteria:

* individuals who are pregnant or breastfeeding;
* underweight (BMI \<18.5);
* have pre-existing medical conditions affecting swallow ability, taste and smell perception;
* currently or within 3 months of starting the study are following a specific dietary programme (e.g.: Slimming World);
* current smokers or have smoked within 3 months of the study start date;
* 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.

Primary outcomes:
measure: Free Sugar Intakes
timeFrame: 12 weeks from baseline
measure: Number of Participants Who Adhered to the Recommendations Provided
timeFrame: 12 weeks from baseline
Secondary outcomes:
measure: Dietary Intakes
timeFrame: 12 weeks from baseline
measure: BMI
timeFrame: 12 weeks from baseline
measure: Sweet Food Preferences
timeFrame: 12 weeks from baseline
measure: Sweet Food Choices
timeFrame: 12 weeks from baseline
measure: Sweet Food Attitudes
timeFrame: 12 weeks from baseline
measure: Number of Participants Reporting Adverse Events
timeFrame: Baseline to 12 weeks
measure: Eating-based Attitudes
timeFrame: Baseline to 12 weeks
measure: Eating-based Motivations
timeFrame: Baseline to 12 weeks
measure: Quality of Life (Subjective Wellbeing)
timeFrame: Baseline to 12 weeks
Other outcomes:
Locations:
city: Bournemouth
country: United Kingdom
facility: Bournemouth University
state: US And Canada Only
Study officials:
affiliation: Bournemouth University
name: Katherine Appleton
role: PRINCIPAL_INVESTIGATOR
References: