Dietary Recommendations for Reducing Free Sugar Intakes

Dietary Recommendations Clinical Trial

Official title:

Dietary Recommendations for Reducing Free Sugar Intakes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04816955
• Other study ID #: PhDBoxall
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: July 31, 2024

Study information

• Verified date: July 2023
• Source: Bournemouth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 242
• Est. completion date: July 31, 2024
• Est. primary completion date: December 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dietary Recommendations

Intervention

Behavioral:
• Dietary recommendations
Dietary recommendations, with increasing additional behavioural/practical advice or no dietary recommendations

Locations

Country	Name	City	State
United Kingdom	Bournemouth University	Bournemouth	US And Canada Only

Sponsors (1)

Lead Sponsor	Collaborator
Bournemouth University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Free sugar intakes	Percentage energy intake from free sugars, assessed using diet diaries	12 weeks from baseline
Primary	Adherence	Adherence to the recommendations provided, assessed using diet diaries and self-reported adherence	12 weeks from baseline
Secondary	Dietary intakes	Nutrient composition of dietary intakes, assessed using diet diaries	12 weeks from baseline
Secondary	BMI	Body Mass Index, assessed using researcher measurements or researcher-observed self-measurements	12 weeks from baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	Adverse events	Adverse events, assessed by self-report	Baseline to 12 weeks
Secondary	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
Secondary	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
Secondary	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