Health Effects of Ultra-processed Food Intake (UPFront)
2026年8月21日 更新者：Göteborg University
Health Effects of Ultra-processed Food Intake: a Randomized Crossover Feeding Study
Ultra-processed food (UPF) intake has been related to negative health effects and increased energy intake in previous intervention studies.
Thus, previous studies have seen weight gain from higher UPF intake which obscures the potential to see effects on cardiometabolic biomarkers, independent of weight changes.
The overall aim of this project is to study the causal effects of a high UPF diet, compared to a nutrient-matched low UPF diet, on appetite and cardiometabolic health in a weight-stable context.
研究概览
研究类型
介入性
注册 (估计的)
40
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Linnea Bärebring, PhD, Associate professor
- 电话号码：+46 0317863771
- 邮箱：linnea.barebring@gu.se
研究联系人备份
- 姓名：Therese Karlsson, PhD, Associate professor
- 邮箱：therese.karlsson@gu.se
学习地点
-
-
-
Gothenburg、瑞典、40530
- 招聘中
- University of Gothenburg
-
接触：
- Linnea Bärebring, PhD, Associate professor
- 电话号码：+46 0317863771
- 邮箱：linnea.barebring@gu.se
-
接触：
- Therese Karlsson, PhD, Associate professor
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
是的
描述
Inclusion Criteria:
- Age 20-60 years
- Weight stable (less than 5% weight change in the past 3 months)
- No plans to change weight
- Willing to eat the study diet and a mixed diet
- Habitually eats breakfast, lunch and dinner
- Has provided informed consent to participate in the study
Exclusion Criteria:
- Allergy or intolerance to foods included in the study. Participants with lactose intolerance treated with lactase may participate if they take enzymes.
- BMI <18.5 or >35 kg/m²
- >8h/week of intense physical activity
- Use of medications known to significantly affect appetite (e.g., oral corticosteroids, antipsychotic medications, or GLP-1 receptor agonists)
- Use of lipid-lowering medications (e.g., statins or PCSK9 inhibitors)
- Diagnosed diabetes or capillary blood glucose at or above 12.2 mmol/L
- Disease associated with malabsorption (e.g., inflammatory bowel disease or celiac disease)
- Previous bariatric surgery
- Established cardiovascular disease (heart failure, myocardial infarction, or stroke) or cancer
- Pregnancy or breastfeeding, or plans to become pregnant or breastfeed during the study
- Deemed likely to have poor adherence
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Sequence 1: high UPF, low UPF
Diet high in UPF, followed by a diet low in UPF
|
Diet high in Ultra-processed food (>80 % of total energy intake)
Diet low in Ultra-processed food (<20 % of total energy intake)
|
|
实验性的：Sequence 2: low UPF, high UPF
Diet low in UPF, followed by a diet high in UPF
|
Diet high in Ultra-processed food (>80 % of total energy intake)
Diet low in Ultra-processed food (<20 % of total energy intake)
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Leptin
大体时间：Change from baseline to 6 weeks
|
Change from baseline to 6 weeks
|
|
|
ApoB
大体时间：Change from baseline to 6 weeks
|
Apolipoprotein B
|
Change from baseline to 6 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Leptin
大体时间：Change from baseline to 2 weeks
|
Change from baseline to 2 weeks
|
|
|
ApoB
大体时间：Change from baseline to 2 weeks
|
Apolipoprotein B
|
Change from baseline to 2 weeks
|
|
Ghrelin, PYY, cholecystokinin, insulin
大体时间：Change from baseline to 2 weeks and from baseline to 6 weeks
|
Other appetite-regulating hormones
|
Change from baseline to 2 weeks and from baseline to 6 weeks
|
|
Blood lipid profile
大体时间：Change from baseline to 2 weeks and from baseline to 6 weeks
|
ApoA1, LDL, HDL, VLDL, total cholesterol, triglycerides, Lp(a)
|
Change from baseline to 2 weeks and from baseline to 6 weeks
|
|
Body weight
大体时间：Change from baseline to 2 weeks and from baseline to 6 weeks
|
Change from baseline to 2 weeks and from baseline to 6 weeks
|
|
|
Body composition
大体时间：Change from baseline to 2 weeks and from baseline to 6 weeks
|
Fat mass and fat-free mass
|
Change from baseline to 2 weeks and from baseline to 6 weeks
|
|
Blood pressure
大体时间：Change from baseline to 2 weeks and from baseline to 6 weeks
|
Diastolic and systolic blood pressure
|
Change from baseline to 2 weeks and from baseline to 6 weeks
|
|
Biomarkers of ultra-processed food intake
大体时间：At 2 weeks and at 6 weeks
|
Measured in blood and urine
|
At 2 weeks and at 6 weeks
|
|
Gut microbiome
大体时间：At 2 weeks and 6 weeks
|
Change in gut microbial composition and diversity (alpha- and beta)
|
At 2 weeks and 6 weeks
|
|
Glucose
大体时间：Continuous during the first 2 weeks
|
Glucose, measured by continuous blood glucose monitoring
|
Continuous during the first 2 weeks
|
|
Energy intake
大体时间：Change from baseline to 2 weeks and from baseline to 6 weeks
|
Ad libitum energy intake at standardized test meal
|
Change from baseline to 2 weeks and from baseline to 6 weeks
|
|
Food cravings and eating behavior
大体时间：Change from baseline to 2 weeks and from baseline to 6 weeks
|
Control of Eating Questionnaire, Three Factor Eating Questionnaire, Power of Food Scale
|
Change from baseline to 2 weeks and from baseline to 6 weeks
|
|
Subjective appetite
大体时间：Change from baseline to 2 weeks and from baseline to 6 weeks
|
Self-rated appetite before and after a standardized test meal
|
Change from baseline to 2 weeks and from baseline to 6 weeks
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Oral microbiome
大体时间：At 2 weeks and 6 weeks
|
Change in oral microbial composition
|
At 2 weeks and 6 weeks
|
|
Compliance
大体时间：At 2 weeks and 6 weeks
|
Compliance assessed by food records
|
At 2 weeks and 6 weeks
|
|
Sleep
大体时间：Change from baseline to 2 weeks and from baseline to 6 weeks
|
Pittsburgh Sleep Quality Index
|
Change from baseline to 2 weeks and from baseline to 6 weeks
|
|
Well-being
大体时间：Change from baseline to 2 weeks and from baseline to 6 weeks
|
WHO-5 Wellbeing Index
|
Change from baseline to 2 weeks and from baseline to 6 weeks
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Linnea Bärebring, PhD, Associate professor、Göteborg University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年6月25日
初级完成 (估计的)
2027年12月1日
研究完成 (估计的)
2027年12月1日
研究注册日期
首次提交
2026年6月3日
首先提交符合 QC 标准的
2026年6月3日
首次发布 (实际的)
2026年6月8日
研究记录更新
最后更新发布 (实际的)
2026年8月24日
上次提交的符合 QC 标准的更新
2026年8月21日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- 2025-08976-01
- 2025 (美国 NIH 拨款/合同：Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
未定
IPD 计划说明
Ethical approvals and legal issues must be considered and resolved before data of individuals can be shared.
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不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.