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NCT05616585
Dietary Biomarkers Intervention Core
Conditions: Biological Markers, Diet, Healthy, Metabolomics, Nutrition, Healthy
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Phase: NA
Enrollment: 115
Sponsor: Harvard School of Public Health (HSPH)
Location: United States
Summary
The purpose of this controlled feeding trial is to establish an Intervention Core, equipped to perform tightly controlled pharmacokinetic (PK) and dose-response (DR) feeding studies.This research is a two-component pharmacokinetic and pharmacodynamic cross-over dietary feeding trial.In the PK study, eight foods will be tested, each on a single day, and the design is crossover.In the DR, the effects of 10 foods will be compared to each other in a randomized, parallel-group design, and the dose-effect of each of the 10 foods will be determined in a randomized, crossover design.
Eligibility Criteria
Inclusion Criteria:Healthy adults Men and women, 18+Body Mass Index (BMI) 18.5-39.9
kg/m2Willingness to participate in all study visitsExclusion Criteria:History of gastrointestinal conditions (e.g., ulcerative colitis, Crohn disease, celiac sprue, Hereditary Non-polyposis Colorectal Cancer, familial adenomatous polyposis, pancreatic disease, liver disease)Bleeding disorders that preclude blood drawsAnemia- as self-reported in the Screening QuestionnairePrevious gastrointestinal resection or gastric bypass surgeryRecent hospital admissions (in past 6 months) for heart disease (myocardial infarction, cerebrovascular accident, or congestive heart failure) or other cerebrovascular/ coronary artery disease condition under physician guided therapy that is not medically stable.Cancer under radiation or chemotherapy treatment that is active or within 6 months of treatment.
Except for non-melanoma skin cancer.Women who are pregnant or lactatingWeight change (±5% in3 months)Regular alcohol intake of >2 drinks/day (2 drinks being equivalent to 720 ml beer, 240 ml wine, or 90 ml spirits) and unwilling to abstain during feeding periodsUse of tobacco, marijuana, hookahs, vape, or e-cigarettes and not willing to abstain during feeding periods.Use of illicit drugs and not willing abstain during feeding periods.Body mass index >40 kg/m2Hypertension- seated blood pressure >140 mmHg or diastolic >90 mmHgFood allergies/intolerances or major dislikes to foods used in the study menus; unwilling to consume study foods.Regular (daily to weekly) use of over-the-counter weight-loss aids, anti-inflammatories, and unwilling to stop taking these during feeding periodsUnwilling to stop taking over the counter dietary supplements that interfere with the test foods being studied, including pills, chewable, liquids or powders for the following: protein supplements, soy, fiber, flaxseed, fish oil (incl.
cod liver oil), probiotics, carotenoids, selenium, other antioxidants, other phytochemicals, glucosamine, and chondroitin.
If vitamin supplement is MD prescribed, the participant may be enrolled subject to the investigator's judgment.
Staff will review supplement to determine eligibility.Oral or IV antibiotic use in the past 3 months (could defer participation until 3 months post completion of course of antibiotics)Inability to freely give informed consentClinical lab tests outside acceptable value as ascertained at a screening blood draw and current use of specific prescription medications per self-reportDescription [Acceptable Values]Glucose-Fasting: Serum Glucose [54-125 mg/dl]Blood Urea Nitrogen [6-50mg/dl]Serum Creatinine [0.4-1.3 mg/dl]Estimated glomerular filtration rate (eGFR) [>60ml/min]Serum Sodium [133-146 mmol/L]Alanine Aminotransferase/glutamate-pyruvate transaminase (ALT/GPT) Liver Enzyme [5-60 U/L]Aspartate aminotransferase (AST/GOT) Liver Enzyme [5-40 U/L]Alkaline Phosphatase Liver Enzyme [20-135 U/L]Total Bilirubin Liver Function [0.0-1.9 mg/dl]Total Serum Protein [5-9.0 g/dl]Albumin Serum Protein [3.5-5.9 g/dl]LDL Cholesterol [<160 mg/dl]Triglycerides [<500 mg/dl]White Blood Cells (WBC) [3-10.5 K/per microliter (μL)]Hematocrit (HCT) (women) [35-48 g/dl]Hematocrit (HCT) (men) [37.5-49 g/dl]Prescription Medications that would Exclude Participation:DiureticsSteroids (oral): daily oral any dose within 1 month of study, except as noted belowNonsteroidal anti-inflammatory drugs (NSAIDS): when prescribed for treatment or is regularly consumed (i.e.. Daily), or can't be stopped for 2 days without pain, except 81 mg AspirinOpiates: any use within 1 month of studyAntilipemic Agents that affect GI or renal function (i.e.. Fibrates)Antidiabetics and Hypoglycemic medications other than metformin (i.e.. insulin, SGLT2 inhibitor, α-glucosidase inhibitor)Psychiatric that affect metabolism/renal function (anti-psychotics, lithium)Biologics/immune modulators (i.e.. rheumatoid arthritis (RA), psoriasis, other rheumatologic/hematologic active disease)Anti-coagulants (coumadin, heparin, Eliquis, etc.)Human immunodeficiency virus (HIV) or highly active antiretroviral therapy (HAART) , etc.Medications that are approved: Steroids (nasal or topical), Aspirin, NSAIDS and Tylenol (avoid day before and day of study visit, Statins, Metformin, Psychiatric drugs other than anti-psychotics (SSRI, tricyclics, benzo), oral contraception pill (OCP)/Hormonal Replacement Therapy (HRT), Tobacco cessation products (patches/lozenge), Oral contraceptives, Gender- affirming HRT, Testosterone for hypogonadal males.
Source: ClinicalTrials.gov (NCT05616585). StuddyBuddy aggregates publicly available trial information.