Effect of Citrus Bioflavonoids/Vitamin E in Conjunction With Fish Oil Supplementation

MetaProteomics

Status: Completed

Conditions: Hyperlipidemia

Treatments: Dietary Supplement: placebo; Dietary Supplement: FishOil; Dietary Supplement: CBE75; Dietary Supplement: CBE150

Study type: Interventional

Funder types: Industry

Identifiers

NCT01671254

POT2-FMR-CT

Details and patient eligibility

About

The purpose of this 8-week intervention trial is to investigate the effect of a dietary supplement (containing citrus bioflavonoids and vitamin E) plus fish oil supplementation in healthy hyperlipidemic subjects

Enrollment: 18 patients

Sex: All

Ages: 18 to 72 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• men and women ≥ 18 and ≤ 72 years old
• generally healthy
• BMI > 18 and < 38
• LDL cholesterol ≥ 130 mg/dl and < 270 mg/dl
• triglycerides ≥ 150 mg/dl and < 400 mg/dl
• ability to understand and the willingness to sign a written informed consent

Exclusion criteria

• use of nutritional supplements and medical foods for dyslipidemia within 30 days prior to the study
• use of omega-3 fatty acid dietary supplements within 30 days prior to the study
• use of prescription HMG-CoA reductase inhibitors, bile acid sequestrants, fibrates, cholesterol absorption blocking agents, or niacin
• use of prescription medications and/or nonprescription medications for acute and semi-acute medical conditions
• history of cardiovascular disease, type i diabetes, autoimmune disease, liver or kidney disease, malignancy, and serious mental illness.
• known infection with HIB, TB, hepatitis B or hepatitis C
• history of allergy or intolerance to study products
• smoking, use of nicotine-containing products, or use of drugs of abuse 30 days prior to the study
• history of regular intake of > 14 alcoholic drinks per week for females and > 21 drinks per week for males

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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18 participants in 3 patient groups

FishOil + placebo

Active Comparator group

Description:

Subjects in this arm receive fish oil (EPA/DHA Extra Strength) and placebo capsule

Treatment:

Dietary Supplement: placebo

Dietary Supplement: FishOil

FishOil + CBE75

Experimental group

Description:

Subjects in this arm receive fish oil (EPA/DHA Extra Strength) and citrus bioflavonoids+vitamin E (CBE)(75 mg/capsule/day)

Treatment:

Dietary Supplement: FishOil

Dietary Supplement: CBE75

FishOil + CBE150

Experimental group

Description:

Subjects in this arm receive fish oil (EPA/DHA Extra Strength) and CBE (150 mg/capsule/day)

Treatment:

Dietary Supplement: FishOil

Dietary Supplement: CBE150