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临床试验/NCT06113146
NCT06113146已完成不适用

Impact of the Eating Rate of Ultra-processed Foods on Dietary Intake Behavior and Metabolic Responses

Wageningen University2 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2023年10月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
41
试验地点
2
主要终点
Average daily energy intake (kcal/day)

研究概览

简要总结

The aim of this balanced-order block randomized controlled cross-over trial with 2 treatment arms is to determine the effect of eating rate (ER) of ultra-processed food diets (UPF fast ER vs UPF slow ER) on ad libitum energy intake across a two week period.

详细描述

Rationale: Consumption of industrially processed foods has been associated with obesity and related adverse health outcomes. If this reflects a causal relationship, it is unknown what attributes or properties of industrially processed foods might drive this association. Extensive research has shown that foods consumed with a texture-derived slow eating rate (ER) are consumed in smaller amounts relative to foods consumed with a fast ER. ER has been suggested as one of the mechanisms why (ultra-)processed foods (with a fast ER) may promote excess in calorie intakes. We will therefore test the hypothesis that ER moderates energy intakes from ultra-processed foods.

Objective: The primary objective of this study is to determine the effect of ER of ultra-processed food diets (UPF slow ER vs UPF fast ER) on ad libitum energy intake (kcal/day) across a two week period. The secondary objectives are to compare body composition and metabolic changes that occur when on a 14 day diet of ultra-processed foods with either a slow or a fast ER.

Study design: We will conduct a balanced-order, block randomized controlled cross-over trial with 2 treatment arms, to determine the effect of ER of ultra-processed food diets (UPF fast ER vs UPF slow ER) on ad libitum energy intake (kcal) across a two week period. The study will have a run-in period to determine habitual dietary habits (baseline) and a washout period (14 days) between treatments to prevent carry-over effects. All participants will receive both treatments and are their own control (within subject design).

Study population: 39 healthy, non-smoking, adults between 21-50 years old and with a BMI between 21-27 kg/m2 will be included.

Intervention: The two treatments are 1) a 14-days ultra-processed, slow ER diet, and 2) a 14-days ultra-processed, fast ER diet. The ad libitum meal menus are matched for energy density (kcal/g), liking (hedonic range), and level of processing, but different in textural characteristics known to influence ER. During the treatment periods participants eat all of their main meals at the research site on weekdays. Participants receive pre-packed meals to consume at home for the weekends. Meals are served ad-libitum, presented in portions that are > 200% of a regular portion size. Participants are asked to eat from each meal until they feel comfortably full. Food (gram) and energy (kcal) consumed will be recorded at the level of the meal, the day and week of the interventions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Double (Participant, Outcomes Assessor)

盲法说明

To cover the true aim of the study, participants will be told that the study is about different types of protein and body composition changes and that this is not a weight-loss study. Participants will be debriefed about the true study aim by email when the last participant finishes the study.

Equal numbers of participants will be randomly allocated to each treatment order. The allocation sequence will be concealed until participants are enrolled and assigned to the intervention orders. Meals will be given a 3 random-digit code to conceal treatment allocation. However, the diets cannot be administered in a fully blinded manner due to the nature of the study foods. Study participants and research staff involved in food provision might be able to identify differences between the diets based on the types of foods served.

Data is blinded by an independent researcher outside of the research project and unblinding will occur after the primary analyses have been conducted.

入排标准

年龄范围
21 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Average daily energy intake (kcal/day)

时间窗: Two periods of 14 days

The average (across two weeks) daily energy intake (kcal/day) in each diet arm

次要结局

  • Cumulative energy intake (kcal)(Two periods of 14 days)
  • Total Energy intake (kcal)(Two periods of 14 days)
  • Total Food intake (gram)(Two periods of 14 days)
  • Body weight (kg)(Pre and post intervention periods and six times (every other day) during each intervention period of 14 days)
  • Postprandial hormone responses (Mixed Meal Tolerance Test)(Baseline and post 14-day intervention periods)
  • Leptin and Ghrelin levels (Fasted state)(Baseline and post 14-day intervention periods)
  • Cumulative food intake (gram)(Two periods of 14 days)
  • Total and Regional Fat Mass and Fat Free Mass (kg, %)(Pre and post 14-day intervention periods)
  • Metabolic outcomes (Mixed Meal Tolerance Test)(Baseline and post 14-day intervention periods)
  • Glucose Excursions(Every 15 minutes throughout two 14-day intervention periods)
  • Blood lipid profile (Fasted state)(Baseline and post 14-day intervention periods)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ciaran Forde

prof.dr. CG (Ciarán) Forde

Wageningen University

研究点 (2)

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