Metabolomics-Driven Insights Into Ultra-Processed Foods: Identifying High-Risk UPF Subtypes for T2D Prevention
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Within-person metabolomic response during each UPF test diet, compared to the paired non-UPF control diet.
研究概览
简要总结
The goal of this dietary intervention study in generally healthy adults is to develop new ways to use blood samples to measure the common types of highly processed foods and beverages that people eat on a regular basis. The main aims to answer are:
What small molecules are elevated in blood after eating different types of highly processed foods and beverages consistently for 1 week?
Researchers will compare 3 different test diets with 1 control diet that does not have any highly processed foods in the same individuals to see which circulating blood markers change.
Participants will:
- Complete 3 diet phases, each 2 weeks long
- Receive a meal plan and study foods and beverages to follow for each 2-week phase
- Come to the clinic every week for blood draws, urine samples, and stool collection kits
详细描述
UPFs, characterized by industrial processing and the use of cosmetic additives for enhanced palatability and extended shelf-life, account for approximately 58% of caloric intake in the U.S. population. Although some UPF subtypes have been implicated in increasing risk of T2D and other chronic diseases, others may be relatively inert or even beneficial, underscoring the need for discerning their distinct health effects. This trial is a controlled crossover feeding trial design with target enrollment of 40 generally healthy adults. Partcipants complete 3 2-week isocaloric dietary intervention phases, with 1 week of a control diet of non-ultraprocessed foods and beverages, and 1 week of a UPF-based test diet. The 3 UPF test diets each feature a menu consisting of a UPF subtype: starchy and refined grains, meats and fish, or dairy-based products. Foods and beverages are provided during the diet phases, and participants will attend weekly clinic visits for in-person assessments and biospecimen collections. We will obtain metabolomic profiling of the fasting plasma samples and conduct data analyses to isolate novel biomarkers that reflect the intake of the UPFs, such as industrial additives. These objective signatures of UPF intake will support subsequent research investigating the long-term health outcomes relate d to UPF consumption. Identifying metabolomic signatures of UPF subtypes will enhance the understanding of the biological mechanisms linking UPFs to T2D and other chronic disease risks.
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
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults, ages 20 to 65 years.
- •BMI 18.5 to 39.9 kg/m
- •No known food allergies, intolerances, or sensitivities (e.g., gluten, dairy, monosodium-glutamate).
- •Not following a restrictive diet for health, religious, or other reasons (e.g., vegetarian, vegan).
- •Willingness to participate and give informed consent.
- •Willingness to consume dietary intervention foods and beverages.
排除标准
- •BMI <18.5 or >39.9 kg/m
- •Pregnant, lactating, or planning on becoming pregnant in the next 6 months.
- •History of bariatric surgery.
- •Currently taking medications impacting appetite or body weight.
- •History of major chronic diseases, including cardiovascular disease, type 1 or 2 diabetes, major gastrointestinal conditions, uncontrolled hypertension (seated blood pressure systolic >140 mmHg or diastolic >90 mmHg), history of invasive cancer, current use of immunosuppressants, and other major chronic diseases and conditions affecting participation, adherence, or study endpoints.
- •Unwilling or unable to comply with all in person scheduled visits, dietary protocols, study protocol, and other study procedures.
- •Food allergies or aversions to the foods provided in the dietary interventions.
- •Non-English speaking.
- •Other members of the same household are already participating in the research study.
- •Planning on moving out of the Boston area in the next 6 months.
研究组 & 干预措施
Sequence 2
Participants receive Diet A, followed by Diet C, followed by Diet B.
干预措施: UPF Diet C: Dairy products, including cheese and cream (Other)
Sequence 1
Participants receive Diet A, followed by Diet B, followed by Diet C.
干预措施: UPF Test Diet A: Starchy, refined grains (Other)
Sequence 1
Participants receive Diet A, followed by Diet B, followed by Diet C.
干预措施: UPF Test Diet B: Meat, fish, and bread products (Other)
Sequence 1
Participants receive Diet A, followed by Diet B, followed by Diet C.
干预措施: UPF Diet C: Dairy products, including cheese and cream (Other)
Sequence 2
Participants receive Diet A, followed by Diet C, followed by Diet B.
干预措施: UPF Test Diet A: Starchy, refined grains (Other)
Sequence 2
Participants receive Diet A, followed by Diet C, followed by Diet B.
干预措施: UPF Test Diet B: Meat, fish, and bread products (Other)
Sequence 3
Participants receive Diet B, followed by Diet A, followed by Diet C.
干预措施: UPF Test Diet A: Starchy, refined grains (Other)
Sequence 3
Participants receive Diet B, followed by Diet A, followed by Diet C.
干预措施: UPF Test Diet B: Meat, fish, and bread products (Other)
Sequence 3
Participants receive Diet B, followed by Diet A, followed by Diet C.
干预措施: UPF Diet C: Dairy products, including cheese and cream (Other)
Sequence 4
Participants receive Diet B, followed by Diet C, followed by Diet A.
干预措施: UPF Test Diet A: Starchy, refined grains (Other)
Sequence 4
Participants receive Diet B, followed by Diet C, followed by Diet A.
干预措施: UPF Test Diet B: Meat, fish, and bread products (Other)
Sequence 4
Participants receive Diet B, followed by Diet C, followed by Diet A.
干预措施: UPF Diet C: Dairy products, including cheese and cream (Other)
Sequence 5
Participants receive Diet C, followed by Diet A, followed by Diet B.
干预措施: UPF Test Diet A: Starchy, refined grains (Other)
Sequence 5
Participants receive Diet C, followed by Diet A, followed by Diet B.
干预措施: UPF Test Diet B: Meat, fish, and bread products (Other)
Sequence 5
Participants receive Diet C, followed by Diet A, followed by Diet B.
干预措施: UPF Diet C: Dairy products, including cheese and cream (Other)
Sequence 6
Participants receive Diet C, followed by Diet B, followed by Diet A.
干预措施: UPF Test Diet A: Starchy, refined grains (Other)
Sequence 6
Participants receive Diet C, followed by Diet B, followed by Diet A.
干预措施: UPF Test Diet B: Meat, fish, and bread products (Other)
Sequence 6
Participants receive Diet C, followed by Diet B, followed by Diet A.
干预措施: UPF Diet C: Dairy products, including cheese and cream (Other)
结局指标
主要结局
Within-person metabolomic response during each UPF test diet, compared to the paired non-UPF control diet.
时间窗: Day 0, Day 7, and Day 14 of each dietary intervention period
The primary outcome for this study is within-person metabolomic response during each UPF test diet, compared to the paired non-UPF control diet. Metabolomic responses will be quantified from metabolite concentrations (e.g., relative abundance) measured in fasting plasma samples collected at day 0, day 7, and day 14 in each diet phase.
次要结局
未报告次要终点
研究者
Deirdre K Tobias, ScD
Associate Professor, Epidemiologist
Brigham and Women's Hospital