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Dietary Recommendations for Reducing Free Sugar Intakes

B

Bournemouth University

Status

Completed

Conditions

Dietary Recommendations

Treatments

Behavioral: Dietary recommendations

Study type

Interventional

Funder types

Other

Identifiers

NCT04816955
PhDBoxall

Details and patient eligibility

About

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.

Full 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.

Enrollment

242 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

242 participants in 4 patient groups, including a placebo group

Nutrient-based recommendations
Experimental group
Description:
Participants in this group will be given nutrient-based recommendations to reduce free sugar intakes.
Treatment:
Behavioral: Dietary recommendations
Nutrient- and food-based recommendations
Experimental group
Description:
Participants in this group will be given nutrient- and food-based recommendations to reduce free sugar intakes.
Treatment:
Behavioral: Dietary recommendations
Nutrient- and food-based recommendations with food swaps
Experimental group
Description:
Participants in this group will be given nutrient- and food-based recommendations and advice on food swaps to reduce free sugar intakes.
Treatment:
Behavioral: Dietary recommendations
Control
Placebo Comparator group
Description:
Participants in this group will not be given any recommendations to reduce free sugar intakes.
Treatment:
Behavioral: Dietary recommendations

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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