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Effects of phytosterols and the combination of phytosterols and phospholipids on lipid metabolism and antioxidant effects in populations with borderline high cholesterol

Effects of the combination of phytosterols and phospholipids on lipid metabolism effects in populations with borderline high cholesterol

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078782
Enrollment
Unknown
Registered
2023-12-18
Start date
2023-12-18
Completion date
Unknown
Last updated
2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

borderline high blood cholesterol

Interventions

Placebo control group:Placebo (3.3g/d starch)
Phytosterol intervention group:Phytosterol (2.0g/d) and starch (1.3g/d)
Phytosterol and phospholipid intervention group:Phytosterol (2.0g/d) and phospholipid (0.825g/d) and starch (0.475g/d)

Sponsors

Qingdao University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Age ranging from 30 to 65, with no limit on gender or ethnic group; (2) BMI = 24kg/m²; (3) Raised blood lipid margin: it can meet any of the following conditions. Mild hypercholesterolemia: serum 5.2 mmol/L = TC < 6.2 mmol/L or 3.4 mmol/L = LDL-C < 4.1 mmol / L; Mild hypertriglyceridemia: 1.7 mmol/L = TG <2.3 mmol/L; Mild mixed hyperlipidemia: 1.7 mmol/L = TG <2.3mmol / L, and at least one of the following conditions: 5.2 mmol/L = TC <6.2mmol/L,3.4mmol/L = LDL-C < 4.1mmol / L. (4) Patients with good control of chronic diseases such as diabetes and hypertension, and no serious liver, kidney, thyroid, cardiovascular, cerebrovascular, digestive system and other diseases; (5) Did not use any related drugs (such as diuretics, ß receptor blockers, statins or other drugs), and nutritional supplements rich in phytosterols and phospholipids in the past 3 months; (6) Voluntary participation in this study, and signed an informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients with infectious diseases, malignant tumors and mental illness; (2) Allergic constitution and allergy to the ingredients of the test products; (3) Excessive smoking or alcoholism [excessive smoking (= 2 packs / day, = 10 years of smoking age), alcoholism (> 70 g / day for men,> 56 g / day for women); (50ml is equivalent to 1 two) 70g of alcohol is equivalent to 1,700 ml of beer, 750ml of wine and 38° of 250ml of liquor 56g of alcohol is equivalent to 1400ml of beer, 600ml of wine and 38° of 170ml of liquor; Alcohol intake (grams) = alcohol intake (ml) multiply alcohol intake (%) multiply 0.8 (4) Special dietary habits: vegetarians, weight managers, ketogenic diet (high fat, low carbohydrate), etc.; (5) pregnant or lactating women; (6) Unable to follow the trial requirements.

Design outcomes

Primary

MeasureTime frame
Five indice of blood lipid;Oxidative stress index;

Secondary

MeasureTime frame
Erythrocyte membrane fluidity and lipid detection;Fecal sterol and lipid content;Fecal fat content;routine blood test;blood sugar;Liver function index;kidney function index;

Countries

China

Contacts

Public ContactJing Cai

Qingdao University

caijing@qdu.edu.cn+86 151 6523 1565

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026