BridgeMD
New treatment option for Nutrition
Official title Nutrition for Precision Health, Powered by the All of Us
ClinicalTrials.gov ID: NCT05701657
What this study is testing
- What it's testing
- The goal of this Nutrition for Precision Health (NPH) powered by All of Us research study is to develop Artificial Intelligence/Machine Learning (AI/ML) algorithms that predict individual responses to diet patterns using rich multimodal data streams collected across multiple domains (e.g., behavior, social, environmental, clinical and molecular biomarkers). NPH includes a large phenotyping cohort (Module 1, N=8000) and two separate follow-up groups drawn from a subset of Module 1participants.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- Overall Inclusion -- Participants 18 years of age or older who have completed the primary All of Us consent process, Electronic Health Record consent...
- Module 1 -- Must be willing and able to comply with Module 1 protocol; Must provide informed consent for Module 1.
- Module 2 -- Must have completed Module 1; Must provide informed consent for Module 2; Must agree to comply with protocol over a period of...
- Module 3 -- Must have completed Module 1; Must provide informed consent for Module 3; Must agree to comply with protocol over a period of...
You likely can't join if
- Module 1
- Any change to the participant's status from the time of All of Us enrollment that would render them ineligible for All of Us (e.g., being...
- Inability to provide informed consent and engage in informed consent procedures
- Participants who suffer from allergic reactions to, or are unwilling to consume, any components of the liquid mixed meal (e.g., milk products, soy...
- Barriers to safe insertion of peripheral IV canula:
- Contraindications to peripheral IV canula insertion such as local skin infection, inflammation, trauma or burns if all the upper extremities were...
See the full eligibility criteria
Who can join
- Overall Inclusion -- Participants 18 years of age or older who have completed the primary All of Us consent process, Electronic Health Record consent process, have provided at least one All of Us biospecimen suitable...
- Module 1 -- Must be willing and able to comply with Module 1 protocol; Must provide informed consent for Module 1.
- Module 2 -- Must have completed Module 1; Must provide informed consent for Module 2; Must agree to comply with protocol over a period of approximately 10 to 12 weeks and up to six months. This includes consuming only...
- Module 3 -- Must have completed Module 1; Must provide informed consent for Module 3; Must agree to comply with protocol over a period of approximately 10 to 12 weeks and up to 6 months. This includes being domiciled...
What rules you out
- Module 1
- Any change to the participant's status from the time of All of Us enrollment that would render them ineligible for All of Us (e.g., being incarcerated, no longer living in the United States, or withdrawn from that...
- Inability to provide informed consent and engage in informed consent procedures
- Participants who suffer from allergic reactions to, or are unwilling to consume, any components of the liquid mixed meal (e.g., milk products, soy products)
- Barriers to safe insertion of peripheral IV canula:
- Contraindications to peripheral IV canula insertion such as local skin infection, inflammation, trauma or burns if all the upper extremities were involved and there is no unaffected extremity available for IV placement...
- A need for long-term IV access (e.g., ESRD); or
- Lymphedema or deep vein thrombosis (DVT) in the extremity of the IV (in the case where another extremity is not available); or
- Coagulopathy requiring blood thinning products; or
- Arteriovenous (AV) graft or fistula in the extremity of the IV (in the case where another extremity is not available)
- Pregnancy-related conditions:
- Gestational age precluding completion of the Module by 36 weeks. A pregnant participant should complete visit 1 by gestational age 34 weeks, 0 days and complete Module 1 by week 36.
- Severe morning sickness limiting mixed meal tolerance test (MMTT) consumption
- Certain types of disease states:
- Dumping syndrome or inability to consume the volume of the MMTT 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 the volume of the MMTT liquid
- Health conditions requiring chronic blood transfusions or iron infusions
- Hemoglobin \<9.5 g/dL at screening
- Serious illness and in hospice or palliative care for terminal disease
- Swallowing issues:
- Self-reported difficulty tolerating solids or liquids
- Aspiration risks that require change in thickness of liquid or dietary modifications
- Short term antibiotic use. For example, active antibiotics use for an ongoing acute infection
- Blood donation in the last 3 months
- GLP-1 agonist medication (e.g. Semaglutide) instability as defined by less than 3 months of continuous use
- Any disorder, unwillingness, or inability not covered by any other exclusion criteria which, in the investigator's and/or team's opinion jeopardizes the safety of the participant or others or would interfere with...
- Module 2
- Any change to the participant's status from the time of All of Us enrollment that would render them ineligible for All of Us (e.g., being incarcerated, no longer living in the United States, or withdrawn from that study)
- All the above mentioned exclusion criteria for Module 1 (except inability to consume components of the liquid mixed meal)
- Inability to provide informed consent and engage in informed consent procedures
- Inability or failure to complete all critical elements from Module 1 (dietary, physical activity and sleep assessments, continuous glucose monitoring, MMTT)
- Participants who are already enrolled in Module 3
- Participants who are unlikely to be able to adhere to the protocol, based on structured adherence assessment by a study registered dietitian or other trained staff. This includes participants who have known allergic...
- Participants who plan to relocate to an area not served by NPH or travel plans that do not permit completion of the Module over a period of up to 6 months.
- Pregnancy-related conditions:
- Gestational age precluding completion of the Module by week 36. A pregnant participant must be able to begin the first diet by gestational age 26 weeks, 0 days and complete the Module by week 36.
- High risk pregnancy defined as fetal anomaly, gestational hypertension (SBP \>140 mmHg and DBP \>90 mmHg), pre-eclampsia, or gestational diabetes mellitus
- Possible ethanol (alcohol) use disorder defined by Alcohol Use Disorders Identification Test (AUDIT) score of \>15
- History of surgery for the treatment of obesity and:
- Self-reported dumping syndrome; or
- Following a special diet prescribed by their practitioner
- Uncontrolled disease states:
- Hypertension \>160/100mmHg
- Exacerbation of underlying gastrointestinal disease, including inflammatory bowel disease or other malabsorptive disorders
- Decompensated cirrhosis
- Previously diagnosed diabetes Mellitus with HbA1c \>12% at screening
- Newly diagnosed diabetes within the past three months, or HbA1c \>6.5% at screening in a person not previously diagnosed with diabetes.
- 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
- 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...
- Module 3
- All the above mentioned exclusion criteria for Modules 1 and 2
- Participants who are already enrolled in Module 2
- 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 would interfere with adherence to...
- Inability to abstain from tobacco or nicotine use, vaping, alcohol, illicit drug use, or recreational drug use for two (2) consecutive weeks while domiciled in the clinical unit. Nicotine gum, pouch, or patch are...
- Any condition requiring in-person treatments or visits during the study period. This will not be accommodated by the domiciling protocol; however, tele-health visits with the participants regular doctor are permitted.
- Lactation or other infant care needs that cannot be accommodated while domiciled in the clinical unit
- Depression as assessed by:
- Patient Health Questionnaire (PHQ-9) score ≥ 15; or
- Affirmative answer to PHQ-9 suicidality question: "Thoughts that you would be better off dead or of hurting yourself in some way"
- Unable to engage in daily self-care activities (e.g., bathing, transferring, toileting, feeding, dressing)
- Uncontrolled endocrine disorders (such as Cushing's disease, pituitary disorders, diabetes)
- Uncontrolled pain requiring frequent or daily treatment, or adjustment of medication requiring weekly or bi-weekly visits. Pain medications used on an as-needed basis (PRN), such as acetaminophen or NSAIDs, are not...
- Chronic prescription medications that would pose logistical and safety issues for participation
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Davis, California, United States
- Los Angeles, California, United States
- West Hollywood, California, United States
- Chicago, Illinois, United States
- Baton Rouge, Louisiana, United States
- New Orleans, Louisiana, United States
- Boston, Massachusetts, United States
- Chapel Hill, North Carolina, United States
- Kannapolis, North Carolina, United States
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Davis, California, United States; Los Angeles, California, United States; West Hollywood, California, United States; Chicago, Illinois, United States; Baton Rouge, Louisiana, United States and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.