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Personalized Nutrition for Health Optimization
Boston, MA
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
Must not have
Module 1 Certain types of disease states -- Dumping syndrome or inability to consume 400 mL of liquid; Severe malabsorption such as history of short gut syndrome or need for parenteral or enteral nutrition; Less than 12-months post-metabolic or bariatric surgery; History of chronic pancreatitis (e.g., Cystic fibrosis) complicated by inability to tolerate 400 mL of fluid; Anemia requiring chronic blood transfusions or iron infusions; Anemia defined as point of care (POC) Hemoglobin <9.5 g/dL at screening; Serious illness and in hospice or palliative care for terminal disease.
Module 2 Uncontrolled disease states -- Hypertension >160/100mmHg; Exacerbation of underlying gastrointestinal disease, including inflammatory bowel disease or other malabsorptive disorders; Decompensated cirrhosis; Diabetes Mellitus with HbA1c >12% at screening; Newly diagnosed diabetes within the past three months or diagnosed diabetes mellitus at screening (HbA1c >6.5%); Participants with a history of end-stage renal disease (ESRD) on hemodialysis; Active infectious diseases (e.g., active tuberculosis < 3 months from symptom onset or positive test, COVID < 1 month from symptom onset or positive test); Malignancy (e.g., cancer) actively receiving cytotoxic chemotherapy (oral or infusions) treatment except for nonmelanoma skin cancers during the study period; Participants who require dietary restrictions due to a medical condition or are on a prescribed diet for underlying chronic diseases; Participants with Type 1 or Type 2 diabetes on insulin; Participants aged ≥ 75 years with Type 2 diabetes taking prescribed medications that can cause hypoglycemia (e.g. sulfonylureas, glinides), or on a prescribed diet; Hospitalization for a chronic disease (e.g., congestive heart failure, stroke) within the past three months; Requiring transfusions/apheresis during study period; Participants with a current diagnosis of, or who have received treatment for, bulimia or anorexia nervosa within the past 3 years; Participants with major psychiatric disorders, including major depression, schizophrenia, or psychosis, who have been hospitalized in the past six (6) months or are currently enrolled in treatment programs; Anemia defined as point of care (POC) Hemoglobin <9.5 g/dL at screening; Myocardial infarction, invasive cardiac procedure, participation in a cardiac or acute rehabilitation programs, transient ischemic attacks, or unstable arrhythmias within the past 3 months; Any disorder, unwillingness, or inability not covered by any other exclusion criteria which, in the investigator's opinion, might jeopardize the safety of the participant or others, or be expected to interfere with adherence to the protocol.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
No Placebo-Only Group
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.
See full description
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.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
Module 1 Certain types of disease states -- Dumping syndrome or inability to consume 400 mL of liquid; Severe malabsorption such as history of short gut syndrome or need for parenteral or enteral nutrition; Less than 12-months post-metabolic or bariatric surgery; History of chronic pancreatitis (e.g., Cystic fibrosis) complicated by inability to tolerate 400 mL of fluid; Anemia requiring chronic blood transfusions or iron infusions; Anemia defined as point of care (POC) Hemoglobin <9.5 g/dL at screening; Serious illness and in hospice or palliative care for terminal disease.
Select...
Module 2 Uncontrolled disease states -- Hypertension >160/100mmHg; Exacerbation of underlying gastrointestinal disease, including inflammatory bowel disease or other malabsorptive disorders; Decompensated cirrhosis; Diabetes Mellitus with HbA1c >12% at screening; Newly diagnosed diabetes within the past three months or diagnosed diabetes mellitus at screening (HbA1c >6.5%); Participants with a history of end-stage renal disease (ESRD) on hemodialysis; Active infectious diseases (e.g., active tuberculosis < 3 months from symptom onset or positive test, COVID < 1 month from symptom onset or positive test); Malignancy (e.g., cancer) actively receiving cytotoxic chemotherapy (oral or infusions) treatment except for nonmelanoma skin cancers during the study period; Participants who require dietary restrictions due to a medical condition or are on a prescribed diet for underlying chronic diseases; Participants with Type 1 or Type 2 diabetes on insulin; Participants aged ≥ 75 years with Type 2 diabetes taking prescribed medications that can cause hypoglycemia (e.g. sulfonylureas, glinides), or on a prescribed diet; Hospitalization for a chronic disease (e.g., congestive heart failure, stroke) within the past three months; Requiring transfusions/apheresis during study period; Participants with a current diagnosis of, or who have received treatment for, bulimia or anorexia nervosa within the past 3 years; Participants with major psychiatric disorders, including major depression, schizophrenia, or psychosis, who have been hospitalized in the past six (6) months or are currently enrolled in treatment programs; Anemia defined as point of care (POC) Hemoglobin <9.5 g/dL at screening; Myocardial infarction, invasive cardiac procedure, participation in a cardiac or acute rehabilitation programs, transient ischemic attacks, or unstable arrhythmias within the past 3 months; Any disorder, unwillingness, or inability not covered by any other exclusion criteria which, in the investigator's opinion, might jeopardize the safety of the participant or others, or be expected to interfere with adherence to the protocol.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Metabolomic and Microbiome Research
Novel Dietary Methods
Phenotypic Responses
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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), 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
Closest Location:University of Chicago· Chicago, IL· 611 miles
Who is running the clinical trial?
Stevens Institute of TechnologyOTHER
4 Previous Clinical Trials
658 Total Patients Enrolled
United States Military Academy West PointFED
2 Previous Clinical Trials
100,017 Total Patients Enrolled
RTI InternationalLead Sponsor
200 Previous Clinical Trials
933,633 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,895 Previous Clinical Trials
8,045,188 Total Patients Enrolled
University of North Carolina, Chapel HillOTHER
1,587 Previous Clinical Trials
4,356,238 Total Patients Enrolled
Northwestern UniversityOTHER
1,673 Previous Clinical Trials
980,557 Total Patients Enrolled
Illinois Institute of TechnologyOTHER
25 Previous Clinical Trials
7,312 Total Patients Enrolled
University of ChicagoOTHER
1,085 Previous Clinical Trials
836,338 Total Patients Enrolled
Pennington Biomedical Research CenterOTHER
313 Previous Clinical Trials
175,003 Total Patients Enrolled
Louisiana State University Health Sciences Center in New OrleansOTHER
122 Previous Clinical Trials
34,437 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 1
- Group 2: Module 3
- 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.