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NCT05616585
Dietary Biomarkers Intervention Core
NA trial testing Pharmacokinetic (PK)- Controlled Feeding Diet in Biological Markers in 115 participants. Completed in 1 October 2025.
31 August 2025
Quick facts
| Lead sponsor | Harvard School of Public Health (HSPH) |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | single |
| Primary purpose | basic science |
| Enrollment | 115 |
| Start date | 1 February 2023 |
| Primary completion | 31 August 2025 |
| Estimated completion | 1 October 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Pharmacokinetic (PK)- Controlled Feeding Diet
- Dose Response (DR)- Controlled Feeding Diet
Conditions studied
- Biological Markers — all drugs for Biological Markers →
- Diet, Healthy — all drugs for Diet, Healthy →
- Metabolomics — all drugs for Metabolomics →
- Nutrition, Healthy — all drugs for Nutrition, Healthy →
Sponsor
Harvard School of Public Health (HSPH)
Who can join
18 and older, any sex, with Biological Markers or Diet, Healthy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own 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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
The Dietary Biomarkers Development Consortium: An Initiative for Discovery and Validation of Dietary Biomarkers for Precision Nutrition.
Chakraborty H, Sun Q, Bhupathiraju SN, Schenk JM, et al · · 2025 · cited 4× · PMID 40641655 · DOI 10.1016/j.cdnut.2025.107435
Verify or expand the search:
- PubMed search for NCT05616585
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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- NCT06390943 — Low Birthweight and Preterm Infant Feeding Trial and Supportive Care Package: Implementation Research · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05616585 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Harvard School of Public Health (HSPH)
- Last refreshed: 7 October 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05616585.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing