Multiple clinical trials evaluate the physiological and metabolic impacts of sucrose, encompassing conditions such as metabolic disturbance, increased gut permeability, iron deficiency anemia, altered oral pH, and gut microflora dynamics. Sponsored by academic and commercial entities, these studies range across Phase 1/Phase 2, Phase 4, and unclassified designs, with recruitment statuses spanning recruiting, not yet recruiting, and completed. Overall, this research focuses on metabolite shifts, exercise performance, and intestinal microflora profiles in both clinical populations and healthy participants.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06392360 | Recruiting | Metabolic Disturbance|Permeability; Increased |
Appalachian State University|AGRANA |
2024-05-13 | Not Applicable |
| NCT05852145 | Not yet recruiting | pH|Microbiome|Dental Plaque |
Hospital Infantil de Mexico Federico Gomez |
2023-10 | Phase 1|Phase 2 |
| NCT05921968 | Not yet recruiting | Iron Deficiency Anemia |
Ain Shams University |
2023-07-30 | Phase 4 |
| NCT05264636 | Completed | Healthy|Human Gut Microflora |
Cargill|INQUIS Clinical Research |
2022-02-15 | Not Applicable |
(data from https://clinicaltrials.gov, updated on 2024-05-22)
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).