Status:
ACTIVE_NOT_RECRUITING
Mediterranean-like Unprocessed (CLEAN-MED) Diet Intervention Study of the Gut Microbiome of Healthy Adults
Lead Sponsor:
National Institutes of Health Clinical Center (CC)
Conditions:
Diet Therapy
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
Background: Trillions of tiny organisms-including bacteria, fungi, and viruses-live inside our intestines. These microorganisms break down nutrients in our food, aid our immunity, and help keep us he...
Detailed Description
Study Description: This study (called the CLEAN-MED Diet Study) seeks to examine associations between the gut microbiome, well-being, and adherence to a Mediterranean-like unprocessed food diet. The ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2027
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT05411120
Start Date
August 26 2022
End Date
April 1 2027
Last Update
January 2 2026
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892