COMPLETED

Dietary Biomarkers Intervention Core

Conditions

Biological Markers Diet, Healthy Metabolomics Nutrition, Healthy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Dietary Biomarkers Development Center at Harvard University: Intervention Core

Quick Facts

Study Start:2023-02-01

Study Completion:2025-10-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05616585

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

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

Inclusion Criteria

Exclusion Criteria

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

* 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
* 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.

Contacts and Locations

Principal Investigator

Frank M Sacks, MD

PRINCIPAL_INVESTIGATOR

Harvard School of Public Health (HSPH)

Jonathan S Williams, MD

PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Study Locations (Sites)

Mass General Brigham Center for Clinical Investigation

Boston, Massachusetts, 02115

United States

Collaborators and Investigators

Sponsor: Harvard School of Public Health (HSPH)

Frank M Sacks, MD, PRINCIPAL_INVESTIGATOR, Harvard School of Public Health (HSPH)
Jonathan S Williams, MD, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-01

Study Completion Date2025-10-01

Study Record Updates

Study Start Date2023-02-01

Study Completion Date2025-10-01

Terms related to this study

Additional Relevant MeSH Terms

Biological Markers
Diet, Healthy
Metabolomics
Nutrition, Healthy