Controlled feeding trial to identify dietary biomarkers

Dietary Biomarkers Development Center at Harvard University: Intervention Core

This study is trying to find out if certain foods leave unique markers in the body that can help us better understand what people eat and improve nutrition research.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 115 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Harvard School of Public Health (HSPH) (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT05616585 on ClinicalTrials.gov

What this trial studies

This trial aims to establish an Intervention Core for conducting controlled feeding studies that assess pharmacokinetics and dose-response of various foods. It includes a crossover design for testing eight foods on separate days and a randomized parallel-group design for comparing the effects of ten foods. The goal is to identify objective biomarkers of dietary intake that can enhance the validity of nutrition research. By utilizing metabolomics technology, the study seeks to discover specific metabolites linked to food consumption, addressing gaps in current dietary assessment methods.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18 and older with a BMI between 18.5 and 39.9 kg/m2.

Not a fit: Patients with gastrointestinal conditions, recent hospital admissions for heart disease, or those who are pregnant or lactating may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide reliable biomarkers that improve dietary assessment and public health nutrition strategies.

How similar studies have performed: Other studies utilizing metabolomics for dietary assessment have shown promise, but this specific approach is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Healthy adults Men and women, 18+
* Body Mass Index (BMI) 18.5-39.9 kg/m2
* Willingness to participate in all study visits

Exclusion 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 draws
* Anemia- as self-reported in the Screening Questionnaire
* Previous gastrointestinal resection or gastric bypass surgery
* Recent 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 lactating
* Weight 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 periods
* Use 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/m2
* Hypertension- seated blood pressure \>140 mmHg or diastolic \>90 mmHg
* Food 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 periods
* Unwilling 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 consent
* Clinical lab tests outside acceptable value as ascertained at a screening blood draw and current use of specific prescription medications per self-report

Description \[Acceptable Values\]

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:

* Diuretics
* Steroids (oral): daily oral any dose within 1 month of study, except as noted below
* Nonsteroidal 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 Aspirin
* Opiates: any use within 1 month of study
* Antilipemic 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.

Where this trial is running

Boston, Massachusetts

• Mass General Brigham Center for Clinical Investigation — Boston, Massachusetts, United States (Recruiting)

Study contacts

• Principal investigator: Frank M Sacks, MD — Harvard School of Public Health (HSPH)
• Study coordinator: Frank M Sacks, MD

Conditions Biological Markers; Diet, Healthy; Metabolomics; Nutrition, Healthy