Reducing Free Sugar Intakes: A Role for Sweet Taste II

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Dietary Behaviour
• Intervention / Treatment: Behavioral: Dietary Advice

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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• 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: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sweet Taste; The intervention will be provided to participants in written form, in an opaque sealed envelope.	Behavioral: Dietary Advice; Dietary Advice provided
Active Comparator: Taste; The intervention will be provided to participants in written form, in an opaque sealed envelope.	Behavioral: Dietary Advice; Dietary Advice provided
Active Comparator: No Taste; The intervention will be provided to participants in written form, in an opaque sealed envelope.	Behavioral: Dietary Advice; Dietary Advice provided

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	Baseline to week 4
Adherence	Adherence to the recommendations provided, assessed using diet diaries and self-reported adherence	Baseline to week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dietary Intakes	Nutrient composition and taste of dietary intakes, assessed using diet diaries	Baseline to week 4
Body weight	Body weight, in kg, assessed using researcher measurements	Baseline to week 4
BMI	BMI, in kg/m2, assessed using researcher measurements	Baseline to week 4
Waist circumference	Waist circumference, in cm, assessed using researcher measurements	Baseline to week 4
Body fat percentage	Body fat percentage, assessed using bioimpedence, as conducted by the researcher measurements	Baseline to week 4
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	Baseline to week 4
Sweet food perceptions	Perceptions of the strength of sweet taste for various sweet foods/fluids, assessed using a taste test, where participants sample several sweet and non-sweet foods and rate them for strength of taste on a 100mm Visual Analogue Scale. Higher scores signify stronger perceptions	Baseline to week 4
Sweet food intakes	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	Baseline to week 4
Sweet food attitudes	Attitudes towards sugar, sweeteners, and sweet-tasting foods, assessed using a questionnaire, soon to be published. Higher scores denote stronger attitudes.	Baseline to week 4
Adverse events	Adverse events, assessed by self-report	Baseline to week 4
Eating-based attitudes	Attitudes towards eating, assessed using the Three Factor Eating Questionnaire (Karlsson J, et al. IJO 2000; 24: 1715-1725)	Baseline to week 4
Subjective Quality of Life	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 week 4
Barriers and facilitators to success	An assessment of barriers and facilitators to success, assessed by self-report questionnaire	Baseline to week 4

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• This study is linked to study registration NCT05684757

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Estimated): March 31, 2024
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: June 27, 2023
• First Submitted That Met QC Criteria: June 27, 2023
• First Posted (Actual): July 6, 2023

Study Record Updates

• Last Update Posted (Actual): October 10, 2023
• Last Update Submitted That Met QC Criteria: October 9, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: RFSII2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymised data will be shared with other researchers on reasonable request.
• IPD Sharing Time Frame: From publication of the results
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

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