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临床试验/NCT05932329
NCT05932329已完成不适用

Reducing Free Sugar Intakes: A Role for Sweet Taste II

Bournemouth University2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2023年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
72
试验地点
2
主要终点
Adherence

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

All researchers in contact with participants will be blinded, and all analysts.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • aged 18-65 years;
  • able to provide consent and complete all study materials;
  • consuming >5% of TEI from free sugars;
  • residing in the South of England, and able to attend Bournemouth University for testing.

排除标准

  • individuals who are pregnant or breastfeeding;
  • underweight (BMI <18.5);
  • 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;
  • have pre-existing medical conditions affecting swallow ability, taste and smell perception;
  • currently following a specific dietary programme (e.g.: Slimming World);
  • current smokers or have smoked within 3 months of the study start date.

研究组 & 干预措施

Sweet Taste

Active Comparator

The intervention will be provided to participants in written form, in an opaque sealed envelope.

干预措施: Dietary Advice (Behavioral)

Taste

Active Comparator

The intervention will be provided to participants in written form, in an opaque sealed envelope.

干预措施: Dietary Advice (Behavioral)

No Taste

Active Comparator

The intervention will be provided to participants in written form, in an opaque sealed envelope.

干预措施: Dietary Advice (Behavioral)

结局指标

主要结局

Adherence

时间窗: Baseline to week 4

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

Free sugar intakes

时间窗: Baseline to week 4

Percentage energy intake from free sugars, assessed using diet diaries

次要结局

  • BMI(Baseline to week 4)
  • Waist circumference(Baseline to week 4)
  • Body fat percentage(Baseline to week 4)
  • Sweet food attitudes(Baseline to week 4)
  • Eating-based attitudes(Baseline to week 4)
  • Dietary Intakes(Baseline to week 4)
  • Sweet food intakes(Baseline to week 4)
  • Subjective Quality of Life(Baseline to week 4)
  • Barriers and facilitators to success(Baseline to week 4)
  • Sweet food preferences(Baseline to week 4)
  • Sweet food perceptions(Baseline to week 4)
  • Adverse events(Baseline to week 4)
  • Body weight(Baseline to week 4)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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