Personalized Nutrition for Health Optimization
Trial Summary
What is the purpose of this trial?
The goal of this investigational study is to develop algorithms that predict human response to foods. The main question it aims to answer are: * How does varying foods and eating patterns impact one's biological and physiological responses? * In what ways can novel dietary assessment measures be used to improve dietary assessments and to prescribe assessments to people in future research with increased precision? * Can artificial intelligence and machine learning techniques be combined to prescribe foods and eating patterns to individuals for optimization of their health? There are 3 Modules participants may take part in: * Module 1- A participant's dietary intake and accompanying nutritional status, biological and other measures will be observed over 10 days, as well as physiological responses to a liquid mixed meal tolerance test will be measured. * Module 2- Participants will undergo three controlled dietary interventions provided for 14-days each and separated by washout periods of at least 14 days. Physiological responses following a diet-specific meal test will be measured. * Module 3- Participants will undergo the same three dietary interventions during the same 14 day periods as Module 2 while being studied in-residence. Physiological responses following a liquid mixed meal tolerance test and a diet-specific meal test will be measured.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that chronic prescription medications posing logistical and safety issues may be a concern, so it's best to discuss your specific medications with the study team.
What data supports the effectiveness of the treatment Nutrition for Precision Health, Personalized Nutrition, Precision Nutrition?
Is personalized nutrition safe for humans?
The research on personalized nutrition does not specifically address safety concerns, but it emphasizes the need for scientific evidence to support its claims. Personalized nutrition aims to tailor dietary recommendations based on individual factors, which suggests a focus on health optimization rather than harm.678910
How does personalized nutrition differ from other treatments for health optimization?
Personalized nutrition is unique because it tailors dietary recommendations to an individual's specific genetic, phenotypic, and biochemical characteristics, unlike standard treatments that often use a one-size-fits-all approach. This method considers the complex interactions between diet and a person's unique biological makeup, including their gut microbiome, to optimize health outcomes.15111213
Eligibility Criteria
Adults over 18 who've consented to the All of Us study, provided biospecimens for DNA sequencing, and completed certain health modules. They must speak English or Spanish and follow the study's diet-only protocol for up to 6 months. Excluded are those with uncontrolled diseases like severe hypertension, diabetes, infectious diseases; dietary restrictions due to medical conditions; recent major surgeries or hospitalizations; substance abuse issues; and pregnant women beyond a certain gestational stage.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Module 1
Participants' dietary intake and accompanying nutritional status, biological and other measures will be observed over 10 days, including physiological responses to a liquid mixed meal tolerance test.
Module 2
Participants undergo three controlled dietary interventions for 14 days each, separated by washout periods of at least 14 days, with physiological responses measured.
Module 3
Similar to Module 2, but participants are studied in-residence during the dietary interventions.
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Nutrition for Precision Health (Behavioural Intervention)