Clinical Trials

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)

Check the Sucrose product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Hydrolysis of sucrose by brush-border sucrase releases glucose and fructose, which are imported into cells via specific transporters to drive glycolysis and downstream cellular energy production. Modulation of sugar uptake and local carbohydrate concentration affects cellular energetics and osmotic balances, which underlies its relevance to clinical trial conditions including gut permeability, metabolic disturbances, and intestinal microflora composition.

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>).

Note: Technical data last updated: Sep 1, 2026.