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Clinical Trials/NCT05932329
NCT05932329
Active, not recruiting
Not Applicable

Reducing Free Sugar Intakes: A Role for Sweet Taste II

Bournemouth University1 site in 1 country150 target enrollmentJuly 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dietary Behaviour
Sponsor
Bournemouth University
Enrollment
150
Locations
1
Primary Endpoint
Adherence
Status
Active, not recruiting
Last Updated
11 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2023
End Date
July 31, 2025
Last Updated
11 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • aged 18-65 years;
  • able to provide consent and complete all study materials;
  • consuming \>5% of TEI from free sugars;
  • residing in the South of England, and able to attend Bournemouth University for testing.

Exclusion Criteria

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

Outcomes

Primary Outcomes

Adherence

Time Frame: Baseline to week 4

Adherence to the recommendations provided, assessed using diet diaries and self-reported adherence

Free sugar intakes

Time Frame: Baseline to week 4

Percentage energy intake from free sugars, assessed using diet diaries

Secondary Outcomes

  • BMI(Baseline to week 4)
  • Waist circumference(Baseline to week 4)
  • Body fat percentage(Baseline to week 4)
  • Sweet food attitudes(Baseline to week 4)
  • Eating-based attitudes(Baseline to week 4)
  • Dietary Intakes(Baseline to week 4)
  • Sweet food intakes(Baseline to week 4)
  • Subjective Quality of Life(Baseline to week 4)
  • Barriers and facilitators to success(Baseline to week 4)
  • Sweet food preferences(Baseline to week 4)
  • Sweet food perceptions(Baseline to week 4)
  • Adverse events(Baseline to week 4)
  • Body weight(Baseline to week 4)

Study Sites (1)

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