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

NCT01671254 | Completed

• 1 other identifier: POT2-FMR-CT
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hyperlipidemia

Outcome Measures

Primary Outcomes (1)

• LDL cholesterol

  Change in LDL cholesterol level at the end of 8 weeks

  Baseline, 8 weeks

Secondary Outcomes (4)

• Triglyceride

  Baseline, 8 weeks

• oxLDL

  Baseline, 8 weeks

• Total cholesterol

  Baseline, 8 weeks

• HDL cholesterol

  Baseline, 8 weeks

Study Arms (3)

FishOil + placebo

ACTIVE COMPARATOR

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

Dietary Supplement: FishOil; Dietary Supplement: placebo

FishOil + CBE75

EXPERIMENTAL

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

Dietary Supplement: FishOil; Dietary Supplement: CBE75

FishOil + CBE150

EXPERIMENTAL

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

Dietary Supplement: FishOil; Dietary Supplement: CBE150

Interventions

FishOil DIETARY_SUPPLEMENT

FishOil + CBE150; FishOil + CBE75; FishOil + placebo

CBE75 DIETARY_SUPPLEMENT

FishOil + CBE75

CBE150 DIETARY_SUPPLEMENT

FishOil + CBE150

placebo DIETARY_SUPPLEMENT

FishOil + placebo

Eligibility Criteria

• Age: 18 Years - 72 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MetaProteomics LLC: lead

Study Sites (1)

Functional Medicine Research Center

Gig Harbor, Washington, 98332, United States

Location

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Joseph J Lamb, MD

  MetaProteomics / Metagenics / FMRC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2012
• First Posted: August 23, 2012
• Study Start: August 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 18, 2018

Record last verified: 2018-05

Locations

US (1)