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Study on the effects of phytosterols and phytosterols combined with phospholipids on lipid metabolism and anti-oxidation in people with elevated blood cholesterol margin

Study on the effects of phytosterols and phytosterols combined with phospholipids on lipid metabolism and anti-oxidation in people with elevated blood cholesterol margin

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085771
Enrollment
Unknown
Registered
2024-06-18
Start date
2023-10-18
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

hypercholesterolemia

Interventions

Placebo control group:In the placebo group, 3.3g wheat starch capsules were taken with meals at noon and evening, 4 capsules twice a day
Phytosterol group:Plant sterol group 2g plant sterol +1.3g wheat starch per person per day was made into capsules, 4 capsules each time twice a day, and taken with meals at noon and evening
Phytosterol + phospholipid group:Plant sterol + phospholipid group 2g plant sterol +1.3g phospholipid per person per day, made into capsules, 4 capsules each time twice a day, taken with meals at noon

Sponsors

Dongtai People's Hospital, Jiangsu Province
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Male or female aged 18-65 years, 22 kg/m^2= BMI =29.9 kg/m^2; (2) Serum indexes: ?5.2mmol/L = TC < 6.2 mmol/L, ?3.4 mmol/L = LDL-C < 4.1 mmol/L, ?1.7 mmol/L = TG < 2.3 mmol/L, ?4.1 mmol/L = non-HDL-C < 4.9 mmol/L (the above indicators meet ??? or ???) (3) No serious liver, kidney, digestive tract diseases and diabetes and other metabolic diseases; (4) No drugs related to lowering blood lipids have been used within 3 months, and agree not to use drugs during the experiment; (5) Voluntarily participate in this study after listening to the project introduction, and sign the informed consent.

Exclusion criteria

Exclusion criteria: (1) Pregnant or lactating women; (2) Patients with serious diseases such as heart, liver, kidney and hematopoietic system and mental illness; (3) Diagnosed diabetic patients; (4) Those who have taken cholesterol-lowering drugs in the past three months, affecting the judgment of the results; (5) Daily intake of plant sterols or phospholipids products or other foods rich in plant sterols and phospholipids in the past 6 months; (6) excessive use of tobacco or alcohol; (7) Have special eating habits: vegetarians, weight managers, ketogenic diet (high fat, low carbohydrate), etc.; (8) Those who cannot follow the requirements of the test.

Design outcomes

Primary

MeasureTime frame
Serum total cholesterol;Serum triglycerides;Serum high-density lipoprotein cholesterol;Serum low density lipoprotein cholesterol;Serum superoxide dismutase; Serum malondialdehyde;Serum peroxidase;Serum catalase;serum ox-LDL;serum myeloperoxidase;Serum apolipoprotein A1;Serum apolipoprotein B;Serum lipoprotein alpha;

Secondary

MeasureTime frame
Body composition;Serum alanine aminotransferase;Serum aspartate aminotransferase;Serum alkaline phosphatase;Serum lactate dehydrogenase;Serum creatinine;Serum urea nitrogen;

Countries

China

Contacts

Public ContactShenghong Yao; Guiju Sun

Dongtai People's Hospital, Jiangsu Province/ School of Public Health, Southeast University

gjsun@seu.edu.cn+86 139 5192 8860

Outcome results

None listed

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