drugset / Trial / NCT04164446
Supplementation of Oil Palm Phenolics to Healthy Participants
RandomizedParallel-groupTriple-blindPrevention
Summary
Our previous study has found that oil palm phenolics (OPP) supplementation at 9 grams per day is safe for consumption. An interesting observation was reported where the consumption of OPP showed significantly lower total and LDL cholesterol compared to the control group. There is no clinical evidence as yet on the optimum dosage of OPP supplementation in improving fasting lipid profile. We hypothesize that in a clinical study, OPP supplemented participants will elicit a reduction in total and LDL cholesterol while maintaining safety and tolerability.
Timeline
- Start
- 2019-12-16
- Primary completion
- 2020-04
- Completion
- 2020-04
Publications
- Results Fairus S, Leow SS, Mohamed IN, Tan YA, Sundram K, Sambanthamurthi R. A phase I single-blind clinical trial to evaluate the safety of oil palm phenolics (OPP) supplementation in healthy volunteers. Sci Rep. 2018 May 29;8(1):8217. doi: 10.1038/s41598-018-26384-7.
- Muhammad Ismail Tadj NB, Ibrahim N', Haji Mohd Saad Q, Tg Abu Bakar Sidik TMI, Leow SS, Fairus S, Naina Mohamed I. A Phase I, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety and Tolerance of Oil Palm Phenolics (OPP) in Healthy Volunteers. Front Pharmacol. 2022 Jun 20;13:893171. doi: 10.3389/fphar.2022.893171. eCollection 2022.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Oil Palm Phenolics | Unknown | 250 mg | Oral |
| Subject | Oil Palm Phenolics | Unknown | 1000 mg | Oral |
| Subject | Oil Palm Phenolics | Unknown | 2000 mg | Oral |