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Dietary Recommendations for Reducing Free Sugar Intakes

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ClinicalTrials.gov Identifier: NCT04816955
Recruitment Status : Recruiting
First Posted : March 25, 2021
Last Update Posted : June 28, 2021
Sponsor:
Information provided by (Responsible Party):
Bournemouth University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Dietary Recommendations Behavioral: Dietary recommendations Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: The investigator, all researchers and analysts will be blinded to treatment. Participants can not masked.
Primary Purpose: Treatment
Official Title: Dietary Recommendations for Reducing Free Sugar Intakes
Actual Study Start Date : May 1, 2021
Estimated Primary Completion Date : December 20, 2022
Estimated Study Completion Date : September 20, 2023
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Free sugar intakes [ Time Frame: 12 weeks from baseline ]
    Percentage energy intake from free sugars, assessed using diet diaries

  2. Adherence [ Time Frame: 12 weeks from baseline ]
    Adherence to the recommendations provided, assessed using diet diaries and self-reported adherence


Secondary Outcome Measures :
  1. Dietary intakes [ Time Frame: 12 weeks from baseline ]
    Nutrient composition of dietary intakes, assessed using diet diaries

  2. BMI [ Time Frame: 12 weeks from baseline ]
    Body Mass Index, assessed using researcher measurements or researcher-observed self-measurements

  3. Sweet food preferences [ Time Frame: 12 weeks from baseline ]
    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

  4. Sweet food choices [ Time Frame: 12 weeks from baseline ]
    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

  5. Sweet food attitudes [ Time Frame: 12 weeks from baseline ]
    Attitudes towards sugar, sweeteners, and sweet-tasting foods, assessed using a questionnaire, soon to be published. Higher scores denote stronger attitudes.

  6. Adverse events [ Time Frame: Baseline to 12 weeks ]
    Adverse events, assessed by self-report

  7. Eating-based attitudes [ Time Frame: Baseline to 12 weeks ]
    Attitudes towards eating, assessed using the Three Factor Eating Questionnaire (Karlsson J, et al. IJO 2000; 24: 1715-1725)

  8. Eating-based motivations [ Time Frame: Baseline to 12 weeks ]
    Motivations towards eating, assessed using the Food Choice Questionnaire (Steptoe et al., Appetite 1995, 25(3): 267-84). Higher scores denote stronger motivations

  9. Quality of Life (subjective wellbeing) [ Time Frame: Baseline to 12 weeks ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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;
  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04816955


Contacts
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Contact: Katherine Appleton 01202965985 k.appleton@bournemouth.ac.uk
Contact: Suzy Wignall researchethics@bournemouth.ac.uk

Locations
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United Kingdom
Bournemouth University Recruiting
Bournemouth, US And Canada Only, United Kingdom, BH12 5BB
Contact: Katherine Appleton       k.appleton@bournemouth.ac.uk   
Sponsors and Collaborators
Bournemouth University
Investigators
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Principal Investigator: Katherine Appleton Bournemouth University
More Information
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Responsible Party: Bournemouth University
ClinicalTrials.gov Identifier: NCT04816955    
Other Study ID Numbers: PhDBoxall
First Posted: March 25, 2021    Key Record Dates
Last Update Posted: June 28, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymised study data will be available on completion of the trial from the PI
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: On study completion

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bournemouth University:
free sugars
dietary intake
dietary recommendations