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Metabolomics-Driven Insights Into Ultra-Processed Foods

Metabolomics-Driven Insights Into Ultra-Processed Foods: Identifying High-Risk UPF Subtypes for T2D Prevention

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
20 Years to 65 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 1 week
  • Procedures mentioned: Blood draws, Urine samples

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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?"
  • "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"
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests ways to use blood samples to track the highly processed foods and drinks people eat. It is for generally healthy adults ages 20 to 65. Participants follow study meal plans and visit the clinic each week to give samples.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 20 to 65.
  • BMI of 18.5 to 39.9. BMI is a measure of weight compared with height.
  • No known food allergies, trouble tolerating foods, or food sensitivities.
  • Not on a restricted diet for health, religious, or other reasons, such as a vegetarian or vegan diet.
  • Willing to join and give informed consent, which means agreeing after learning about the study.
  • Willing to eat and drink the study foods and beverages.

Who can't join

  • BMI below 18.5 or above 39.9.
  • Pregnant, breastfeeding, or planning to become pregnant in the next 6 months.
  • Past weight-loss surgery, or taking medicines that affect appetite or body weight.
  • History of major long-term illness, such as heart disease, type 1 or 2 diabetes, major stomach or bowel problems, or invasive cancer. Also excluded: uncontrolled blood pressure above 140 for the top number or 90 for the bottom number while seated, medicines that weaken the immune system, or other major conditions that affect study participation or results.
  • Unable or unwilling to follow the study diet, attend all in-person visits, or complete other study steps.
  • Allergies to or strong dislike of the study foods.
  • Do not speak English.
  • Someone in your household is already in the study, or you plan to move out of the Boston area in the next 6 months.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Adults, ages 20 to 65 years. * BMI 18.5 to 39.9 kg/m2. * 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. Exclusion Criteria: * BMI \<18.5 or \>39.9 kg/m2. * 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.

Study sites (1)

MA