Dietary Recommendations for Reducing Free Sugar Intakes

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.

Study Overview

• Status: Completed
• Conditions: Dietary Recommendations
• Intervention / Treatment: Behavioral: Dietary recommendations

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.

• Study Type: Interventional
• Enrollment (Actual): 242
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • US And Canada Only
    • Bournemouth, US And Canada Only, United Kingdom, BH12 5BB
      • Bournemouth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nutrient-based recommendations; Participants in this group will be given nutrient-based recommendations to reduce free sugar intakes.	Behavioral: Dietary recommendations; Dietary recommendations, with increasing additional behavioural/practical advice or no dietary recommendations
Experimental: Nutrient- and food-based recommendations; Participants in this group will be given nutrient- and food-based recommendations to reduce free sugar intakes.	Behavioral: Dietary recommendations; Dietary recommendations, with increasing additional behavioural/practical advice or no dietary recommendations
Experimental: Nutrient- and food-based recommendations with food swaps; Participants in this group will be given nutrient- and food-based recommendations and advice on food swaps to reduce free sugar intakes.	Behavioral: Dietary recommendations; Dietary recommendations, with increasing additional behavioural/practical advice or no dietary recommendations
Placebo Comparator: Control; Participants in this group will not be given any recommendations to reduce free sugar intakes.	Behavioral: Dietary recommendations; Dietary recommendations, with increasing additional behavioural/practical advice or no dietary recommendations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Free Sugar Intakes	Percentage energy intake from free sugars, assessed using diet diaries	12 weeks from baseline
Number of Participants Who Adhered to the Recommendations Provided	Adherence to the recommendations provided, assessed using diet diaries and self-reported adherence	12 weeks from baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMI	Body Mass Index, assessed using researcher measurements or researcher-observed self-measurements	12 weeks from baseline
Dietary Intakes	Energy intake, assessed using diet diaries	12 weeks from baseline
Sweet Food Preferences	Preferences for various sweet foods/fluids, assessed using a taste test, where participants sample several sweet and non-sweet foods and rate them for pleasantness on a 100mm Visual Analogue Scale. Higher scores signify stronger preferences	12 weeks from baseline
Sweet Food Choices	Selection of sweet foods/fluids at a given meal, assessed where participants can consume freely from a meal composed of sweet and non-sweet foods, and proportion of sweet foods consumed is measured in terms of weight consumed	12 weeks from baseline
Sweet Food Attitudes	Attitudes towards sugar, sweeteners, and sweet-tasting foods, assessed using a questionnaire, soon to be published. Higher scores denote stronger attitudes.	12 weeks from baseline
Number of Participants Reporting Adverse Events	Adverse events, assessed by self-report	Baseline to 12 weeks
Eating-based Attitudes	Attitudes towards eating, assessed using the Three Factor Eating Questionnaire (Karlsson J, et al. IJO 2000; 24: 1715-1725)	Baseline to 12 weeks
Eating-based Motivations	Motivations towards eating, assessed using the Food Choice Questionnaire (Steptoe et al., Appetite 1995, 25(3): 267-84). Higher scores denote stronger motivations	Baseline to 12 weeks
Quality of Life (Subjective Wellbeing)	Quality of Life, measured using the SF-36 questionnaire (Ware et al, 1996), where Quality of Life is assessed out of 100, where a higher score demonstrates better quality of life	Baseline to 12 weeks

Collaborators and Investigators

• Sponsor: Bournemouth University
• Investigators: Principal Investigator: Katherine Appleton, Bournemouth University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): December 20, 2022
• Study Completion (Actual): January 31, 2024

Study Registration Dates

• First Submitted: March 17, 2021
• First Submitted That Met QC Criteria: March 24, 2021
• First Posted (Actual): March 25, 2021

Study Record Updates

• Last Update Posted (Actual): June 10, 2025
• Last Update Submitted That Met QC Criteria: June 9, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: dietary intake; free sugars; dietary recommendations
• Other Study ID Numbers: PhDBoxall

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymised study data will be available on completion of the trial from the PI
• IPD Sharing Time Frame: On study completion
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No