Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-25 @ 4:07 AM
NCT ID:
NCT05411120
Eligibility Criteria:
* INCLUSION CRITERIA:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
* Ability of subject to understand and the willingness to sign a written informed consent document
* Age 18-60, at the time of consent
* Willingness to adhere to the dietary regimen and report any major stressors that occur during the study (i.e. changing jobs, moving, death of a close relative/friend, etc.)
* Willingness to provide blood and stool specimens as specified
* BMI \>=18 and \<= 35 kg/m\^2
* Access to necessary resources for participating in a technology-based intervention: computer, smartphone, internet access, etc.
* Has the ability/transportation methods to attend on-site visits
* For 50 of the 60 participants in short-term cohort and for 40 of the 50 participants in the long-term cohort: Currently following a Western diet with PREDIMED-17 MedDiet score \<= 7 for \>= 1 months and a CLEAN-MED NOVA score of \>= 35% kcal in NOVA 4 category with \>= 14 items/week in NOVA 4
* For 10 of the 60 participants in short-term cohort and for 10 of the 50 participants in the long-term cohort: Currently following a Western diet with PREDIMED-17 MedDiet score \<= 10 for \>= 1 months and a CLEAN-MED NOVA score of \>= 20% kcal in NOVA 4 category with \>= 7 items/week in NOVA 4
* CLEAN-MED Logging Score of \>= 43 after initial trial week to continue in the study for the randomization step
* For long-term cohort only: Have resources and capability to consume freshly-cooked (i.e. not pre-packaged or frozen) meals
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation in this study, at the discretion of the PI:
* Current use of medications or dietary supplements for weight or appetite control, whether prescribed or not, including laxatives (within the last 4 weeks)
* Currently eating a vegan, vegetarian, keto or other restrictive diet plan, or food allergies that would affect eating the study diet, at the discretion of the PI
* Active cardiovascular disease (in past year with myocardial infarction, coronary stent or bypass surgery)
* Diabetes (type 1 and 2) or history of gestational diabetes or on hypoglycemic medications or any other indication
* Kidney disease (eGFR less than 50 mL/min per 1.73 m\^2)
* Liver disease (liver transaminase higher than 3 times the normal range for the laboratory)
* Symptomatic gallstones
* History of active cancer in the past 3 years except for squamous or basal cell carcinomas of the skin that have been medically managed by local excision
* Has a diagnosed autoimmune condition (i.e. HIV, lupus, etc.) or other immunosuppressive or immunodeficient state, at the discretion of the PI
* Musculoskeletal disorders precluding regular physical activity
* Consumption of the following drugs: proton pump inhibitors, antidiabetic drugs, cholesterol lowering drugs, SGLT-2 inhibitors, GLP-1 receptor agonist, insulin, Amylin analog, Alpha-glucosidase inhibitor, Dopamine agonist, Bile acid sequestrant, corticosteroids, methotrexate or immunosuppressive cytotoxic agents
* Some types of abdominal surgery, including bariatric surgery, or severe intestinal problems (by discretion of study physician), including:
* Inflammatory bowel disease (IBD) including ulcerative colitis (mild-moderate-severe), Crohn s disease (mild-moderate-severe), or indeterminate colitis;
* Irritable bowel syndrome (IBS) (moderate-severe);
* Persistent, infectious gastroenteritis, colitis or gastritis, persistent or chronic diarrhea of unknown etiology, Clostridium difficile infection (recurrent) or Helicobacter pylori infection (untreated);
* Chronic constipation
* Consumes more than 3 alcoholic beverages per day
* Currently receiving or has received antibiotics, antifungals, antivirals, or antiparasitics in past 2 months
* Is currently using or has used probiotic supplements within the last 2 months
* Is currently on a weight-loss program or has experienced a weight change (gain or loss) of greater than 15 pounds in the past 3 months
* Has a history of hospitalization for mental health condition and/or has had a change in depression or anxiety prescription medications within the past 10 weeks (by discretion of study physician)
* Is pregnant or breastfeeding or planning pregnancy within the time of the study
* Subjects who are not fluent in English
* Use of smoking or chewing tobacco, e-cigarettes, cigars, or other nicotine-containing products, or cannabis
* Regular use of prescription opiate pain medication
* Weight \<100 lbs
* Acute disease, defined as the presence of a moderate or severe illness with or without fever, at the time of enrollment
* Inability to communicate effectively with study personnel
* Lack of commitment with the intervention or non-compliance (at the discretion of the investigator)
* Eating disorders
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT05411120
Study Brief:
Protocol Section:
NCT05411120