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Personalized Nutrition for Health Optimization
N/A
Recruiting
Led By Marie G Gantz, PhD
Research Sponsored by RTI International
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
Study Summary
This trial aims to develop algorithms to predict people's responses to foods & eating patterns, which may improve dietary assessments and help optimize health.
Who is the study for?
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.Check my eligibility
What is being tested?
The trial is testing how different diets (Diet A, B, C) affect biological responses by observing participants' nutritional intake and reactions to specific meal tolerance tests. It uses AI and machine learning to predict food effects on health. Participants may join one of three modules involving controlled diets and in-residence stays for comprehensive monitoring.See study design
What are the potential side effects?
Since this trial involves dietary interventions rather than medications or invasive procedures, side effects are not typical as in drug trials but could include digestive discomfort depending on individual food tolerances and potential allergic reactions to meal components.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Metabolomic and Microbiome Research
Novel Dietary Methods
Phenotypic Responses
Trial Design
3Treatment groups
Experimental Treatment
Group I: Module 3Experimental Treatment5 Interventions
Module 3 is a minimum of 10 weeks long. It includes three (3), 14-day dietary interventions (i.e. Diets A, B, and C) completed while participants are domiciled under the supervision of study staff. At the end of each dietary intervention period, participants return to their usual residence and routine for a minimum of 2 weeks.
At the beginning of each diet period, anthropometry (weight and circumferences), vital signs (temperature, respiratory rate and blood pressure) and body composition by BIA and DXA, and physical measures will be measured. Biospecimens (blood, urine and saliva) will be collected. An accelerometer and a continuous glucose monitoring device will be applied. Excluding pregnant females, participants will receive a dose of doubly labeled water. Weight and vital signs will be measured daily and questionnaires administered.
A diet-specific MMTT and a separate liquid MMTT with timed blood biospecimen collection and visual analogue assessments will be completed.
Group II: Module 2Experimental Treatment4 Interventions
Module 2 is a minimum of 10 weeks long. It includes a total of six (6) study visits that occur before and after each of the three (3), 14-day dietary intervention periods (i.e., Diets A, B, and C), separated by washout periods of at least 14 days. Participants will be asked to consume only the foods provided and to adhere to their other usual routines throughout the study.
At the beginning of each diet period, anthropometry (weight and circumferences), vital signs (temperature, respiratory rate and blood pressure) and body composition by BIA will be measured. Biospecimens (blood, urine and saliva) will be collected. An accelerometer and a continuous glucose monitoring device will be applied for remote data collection. A stool sample collection kit will be provided together with instructions for stool collection and dietary assessments. At the end of each diet, a diet-specific meal test with timed biospecimen blood collection and visual analogue assessments will be completed.
Group III: Module 1Experimental Treatment1 Intervention
Module 1 is approximately 10 days (minimum of 8 days) and includes two study visits and remote data collection. Visit 1 will include application of an accelerometer and continuous glucose monitoring device for remote data collection over the next 8 to 10 days. A stool sample collection kit and instructions for stool collection and completion of dietary assessments during the observation period will be provided.
At Visit 2, anthropometry (height, weight and body circumferences), body composition by bioelectrical impedance (BIA), vital signs (temperature, respiratory rate and blood pressure), resting heart rate variability and grip strength will be measured. Medications will be recorded. A liquid MMTT with timed biospecimen collection (blood, urine, saliva, hair, and nails) and visual analogue assessments will be completed.
Participants in Module 1 will be asked to adhere to their usual routine (e.g., diet, exercise, sleep, supplements, medication use, etc.) throughout the study.
Find a Location
Who is running the clinical trial?
RTI InternationalLead Sponsor
189 Previous Clinical Trials
866,114 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
7,496,850 Total Patients Enrolled
University of North Carolina, Chapel HillOTHER
1,508 Previous Clinical Trials
4,180,825 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I've had surgery for obesity and experience dumping syndrome or follow a special diet.You have severe depression or suicidal thoughts, difficulty taking care of yourself, uncontrolled endocrine disorders, uncontrolled chronic pain that needs frequent medication changes, or take medications that may make it difficult to participate in the study.You must have finished Module 1 and agree to follow the study rules for Module 2, which lasts about 10 to 12 weeks (up to 6 months). During this time, you can only eat the food provided in the controlled feeding periods, which happen three times for two weeks each with at least two weeks break in between.You have difficulty eating or drinking without choking or coughing, require changes in the texture of your food or liquid, are currently taking antibiotics for an infection, or have any other conditions that may put you or others at risk during the study.You must agree to follow the instructions for Module 1 of the study and give your permission to participate.You have already completed Module 1 and provided consent for Module 3. You must agree to follow the study's plan for about 10 to 12 weeks and be willing to stay at a designated location for two weeks, three times during the study. You will only eat the provided foods during these stays, and there will be at least two weeks between each stay. The entire module may take up to 6 months to complete.I am 18 or older, have consented to all required processes, provided a DNA sample, completed necessary surveys, and can follow the study rules.
Research Study Groups:
This trial has the following groups:- Group 1: Module 3
- Group 2: Module 1
- Group 3: Module 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there still room for participants in this research?
"Results from clinicaltrials.gov reveal that this research project is actively seeking partakers; the trial was first made available on April 14th 2023 and has since been refreshed for accuracy on May 25th of the same year."
Answered by AI
What is the full extent of locations where this research project is being conducted?
"This medical research is offered at 15 different sites, such as the USDA Western Human Nutrition Research Center in Davis, University of Alabama Lakeshore Foundation in Sacramento and University of California, Davis in West Hollywood."
Answered by AI
How many participants can potentially take part in this research?
"Affirmative. According to clinicaltrials.gov, this trial, initially posted on April 14th 2023, is actively welcoming participants. A total of 10 000 individuals are required from 15 different sites for the study's success."
Answered by AI
Who else is applying?
What site did they apply to?
Louisiana State University Health Sciences Center
What portion of applicants met pre-screening criteria?
Met criteria
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