Supplementation of Oil Palm Phenolics to Healthy Participants (SPIRAL)

National University of Malaysia

Status and phase: Unknown; Phase 1

Conditions: Hyperlipidemias; Hypercholesterolemia; Cardiovascular Diseases

Treatments: Drug: Placebos; Dietary Supplement: Oil Palm Phenolics

Study type: Interventional

Funder types: Other

Identifiers

NCT04164446

SPIRAL

Details and patient eligibility

About

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.

Full description

During the palm oil milling process, a large amount of vegetation liquor is discarded into the aqueous waste stream. A novel process to recover phenolic compounds from the aqueous waste stream were developed and resulting in producing a filtrate known as oil palm phenolics (OPP), which contains a high amount of phenolic. It has been postulated that phenolic acids components found in the OPP have promising health benefits such as antioxidant, anti-inflammatory, neuroprotective and anti-tumour effects.

Hyperlipidemia, one of the risk factors for cardiovascular diseases (CVD), is defined as elevations of fasting total cholesterol or triglyceride concentration or both. Through our current research, OPP supplementation to hamster animal model has shown positive effects in the reduction of total cholesterol and triglycerides as well as improvement of high-density lipoprotein cholesterol (HDL-C). In a previous study using the rabbit animal model, OPP has shown a protective effect against atherosclerosis, a condition whereby fat and cholesterol plaques are deposited inside the arteries. Based on the current evidence from the preliminary studies on OPP, we hypothesize that supplementation of OPP may prevent or delay the development of CVD.

However, to understand the anti-hyperlipidemic effects of OPP in humans, we need to establish our knowledge of the physiological effects of this compound to normal human subjects. Under physiological condition, OPP may improve the antioxidant and anti-inflammatory status. These improvements may have a positive influence on plasma lipid profile since many scientific evidences demonstrate that antioxidant and anti-inflammatory effects may contribute protection against the incidence of CVD. Therefore, we proposed a clinical trial to evaluate the antioxidant and anti-inflammatory effects of OPP in eliciting the possible mechanism for lipid reduction.

This study will be started with the recruitment of 100 healthy volunteers where they will be supplemented with placebo/OPP capsules at different doses for 60 days. Participants will be required to take the placebo/OPP capsules in front of the study staff to ensure compliance. Blood samples will be withdrawn at baseline, day 30 and day 60, and will be analyzed for lipid profile, antioxidant and anti-inflammatory status. Data from this study would hopefully assist us in understanding the therapeutic roles of OPP on humans under normal conditions.

Enrollment: 100 estimated patients

Sex: All

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy
• Normal Total Cholesterol level of less than 5.2 mmol/dL
• Normal LDL Cholesterol level of less than 3.36 mmol/dL
• Normal Triglyceride level of less than 1.69 mmol/dL

Exclusion criteria

• Smoking
• Habitual alcohol consumption
• Consuming antioxidant supplement
• Pregnant/ breastfeeding
• Medical history of cardiovascular disease, diabetes, dyslipidemia
• Current use of antihypertensive or lipid-lowering medication

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Two capsules containing starch and glucose, once per day, 60 days duration

Treatment:

Drug: Placebos

Oil Palm Phenolics 250 mg

Active Comparator group

Description:

One capsule 250 mg active compound (OPP) and one capsule containing starch and glucose, once per day, 60 days duration

Treatment:

Dietary Supplement: Oil Palm Phenolics

Oil Palm Phenolics 1000 mg

Active Comparator group

Description:

One capsule containing 1000 mg active compound (OPP) and one capsule starch and glucose, once per day, 60 days duration

Treatment:

Dietary Supplement: Oil Palm Phenolics

Oil Palm Phenolics 2000 mg

Active Comparator group

Description:

Two capsules, 1000 mg active compound (OPP) each, once per day, 60 days duration

Treatment:

Dietary Supplement: Oil Palm Phenolics