Safety

A Phase I Multiple Dose Trial of the Safety of Oligonol, a Novel Polyphenol Oligomer, in Healthy Volunteers

Spierings E, et al.2008

Background

The health claims for functional foods and the identification of their active functional ingredients mandates the documentation of any potential toxicity they may present. Phase 1 clinical trials are used to make the initial safety assessment of compounds with potential medical uses.

Study Design

Open-label controlled: Oligonol® was orally administered to healthy subjects twice per day for 14 days. Its effect on various laboratory parameters assessing safety were measured at 7-day intervals. Adverse events were monitored at 7-day intervals..

Results

Laboratory measurements and adverse effects reported after 7 and 14 days of supplementation with Oligonol®:

• No abnormalities in the laboratory parameters between baseline and the final visit.
• There were no changes in the EKG or in the urine analysis between the visits.
• There was no difference found in serum LPO between baseline and the final visit.
• 21 subjects (70%) reported no adverse symptoms during the trial at the interim or final assessment.
• 3 subjects (10%) had abdominal discomfort and bloating at both interim and final visits, but none dropped out.
• 17% of subjects reported other transient symptoms at either the interim or the final visit.

Conclusion

“This data supports previous data in animals and human beings that shows Oligonol® is a safe, well-tolerated nutritional supplement.”