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Clinical Trials/NCT04816955
NCT04816955
Completed
Not Applicable

Dietary Recommendations for Reducing Free Sugar Intakes

Bournemouth University1 site in 1 country242 target enrollmentMay 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dietary Recommendations
Sponsor
Bournemouth University
Enrollment
242
Locations
1
Primary Endpoint
Number of Participants Who Adhered to the Recommendations Provided
Status
Completed
Last Updated
10 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2021
End Date
January 31, 2024
Last Updated
10 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; 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;

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Number of Participants Who Adhered to the Recommendations Provided

Time Frame: 12 weeks from baseline

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

Free Sugar Intakes

Time Frame: 12 weeks from baseline

Percentage energy intake from free sugars, assessed using diet diaries

Secondary Outcomes

  • Dietary Intakes(12 weeks from baseline)
  • BMI(12 weeks from baseline)
  • Sweet Food Preferences(12 weeks from baseline)
  • Sweet Food Choices(12 weeks from baseline)
  • Sweet Food Attitudes(12 weeks from baseline)
  • Number of Participants Reporting Adverse Events(Baseline to 12 weeks)
  • Eating-based Attitudes(Baseline to 12 weeks)
  • Eating-based Motivations(Baseline to 12 weeks)
  • Quality of Life (Subjective Wellbeing)(Baseline to 12 weeks)

Study Sites (1)

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