Effect of Bergamot and Plant Sterols Extract on Serum Lipid Profile

Summary

The consumption of 2 grams of plant sterols per day has been demonstrated to positively affect total cholesterol and low density lipoprotein (LDL) cholesterol, as supported by various clinical guidelines. These compounds do not exhibit any adverse side effects. The European Society of Cardiology's Dyslipidemia Guidelines indicate that among lifestyle modifications aimed at reducing total cholesterol and LDL, the consumption of functional foods enriched with phytosterols should be included as a high-level recommendation.

Bergamot is a citrus fruit rich in flavonoids. Research on bergamot fruit extract has indicated its ability to lower total cholesterol, LDL cholesterol, and triglyceride levels while increasing high density lipoprotein(HDL) cholesterol levels. Furthermore, evidence suggests that it may help reduce high serum uric acid levels, which can pose a risk for cardiovascular diseases. The flavonoids in bergamot fruit extract contribute to the reduction of cholesterol synthesis in the liver. Additionally, it has a high capacity to prevent LDL oxidation. A study on individuals with metabolic syndrome observed significant and sustained reductions in serum cholesterol, triglyceride levels, and glucose in those consuming bergamot. This effect was accompanied by significant improvements in vascular reactivity in patients with hyperlipidemia and elevated serum glucose levels.

Bergamot also exhibits the ability to inhibit 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase. Due to their structural similarity to cholesterol, plant sterols help block the intestinal absorption of dietary cholesterol. They provide benefits at the absorption level and increase cholesterol excretion via bile and fecal pathways. The existence of known side effects associated with cholesterol-lowering medications, such as statins- including muscle cramps, myopathy, increased risk of muscle toxicity, liver damage, and neuropathy-has created a need for complementary or alternative approaches to treating dyslipidemia. This research will consider the potential of both plant sterols and bergamot as dietary supplements.

While cholesterol-lowering diets assist in reducing LDL, glucose, total cholesterol, and triglyceride levels, they do not enhance HDL levels. Because bergamot is known to increase HDL, it could provide an additional benefit in lipid profile regulation. A meta-analysis that studied various phytochemical supplements found that bergamot was the most effective in reducing total cholesterol, LDL, and triglyceride levels while increasing HDL levels. This study examines the effects of dietary supplementation containing plant sterols and bergamot on blood lipid profiles.

Conditions

• Dyslipidemia
• Cardiac Disease
• Cardiovascular Diseases

Interventions

BEHAVIORAL

Diet

Low-fat, low-cholesterol heart-protective diet

DIETARY_SUPPLEMENT

Diet supplementation

2 tablets/daily bergamot and plant sterol/stanol supplement (375 mg bergamot fruit extract, 800 mg plant sterols and 150 mg flavonoids) for 12 weeks

Sponsors & Collaborators

• Istanbul Bilgi University

  lead OTHER

Principal Investigators

• Hande Seven Avuk · İstanbul Bilgi University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-01-04

Primary Completion

2025-05-20

Completion

2025-05-30

Countries

• Turkey (Türkiye)

Study Locations