Metabolism And Health Effects Of Citrus Limonoids in Hypercholesterolemic Humans

NCT02011789 | Completed

• 1 other identifier: FL45
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Limonoids are compounds found in citrus juices, seeds and peel. Some research shows that they reduce blood cholesterol and also reduce the incidence of several forms of cancer. Although these compounds are part of the natural human diet, the dose required to provide health benefits and the risks associated with the intake of high doses by humans have not been studied. This study will examine metabolism, safety, lipid-lowering and anti-inflammatory effects of limonoids. The dose of limonoids in this study is equivalent to that found in six 8 oz glasses of orange juice per day. The investigators hypothesize that limonin glucoside supplementation will reduce total cholesterol, LDL cholesterol, ratio of LDL and HDL cholesterol, number of LDL particles, and serum markers of inflammation.

Conditions

Hypercholesterolemia

Keywords

hypercholesterolemia; inflammation; citrus limonoids

Outcome Measures

Primary Outcomes (1)

• Change in plasma lipids

  Plasma cholesterol, LDL-cholesterol, HDL-cholesterol, triglyceride (TG), and remnant chylomicron particle concentrations will be determined. Lipid particle sizing will be performed by using nuclear magnetic resonance (NMR) technology. Plasma concentrations of apoproteins A1, B, C-III, and E will be measured.

  1, 15, 71 and 127 days

Secondary Outcomes (1)

• Change in liver and renal function

  1, 15, 71 and 127 days

Other Outcomes (1)

• Change in inflammatory markers

  1, 15, 71 and 127 days

Study Arms (2)

Group1

EXPERIMENTAL

Group 1 consumes Placebo beverage for 56 days followed by Citrus Limonoid Beverage for 56 days.

Dietary Supplement: Citrus Limonoid Beverage; Dietary Supplement: Placebo beverage

Group 2

ACTIVE COMPARATOR

Group 2 consumes Citrus Limonoid Beverage for 56 days followed by Placebo beverages for 56 days

Dietary Supplement: Citrus Limonoid Beverage; Dietary Supplement: Placebo beverage

Interventions

Citrus Limonoid Beverage DIETARY_SUPPLEMENT

The limonoid containing beverage will be 12-oz buffered, sterile, orange flavored, artificially sweetened, containing 60 mg vitamin C, 11 mg riboflavin and 250 mg limonin glucoside.

Group 2; Group1

Placebo beverage DIETARY_SUPPLEMENT

The placebo beverage will be 12-oz buffered, sterile, orange flavored, artificially sweetened, containing 60 mg vitamin C and 11 mg riboflavin.

Group 2; Group1

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hypercholesterolemic, total blood cholesterol 200-300 mg/dL
• BMI 20-35 kg/m2
• normal Complete Blood Count
• normal serum transaminases, alkaline phosphatase, and creatinine
• normal thyroid function
• LDL cholesterol \> 130 mg/dL
• Triglyceride \< 300 mg/dL
• serum C-Reactive Protein 1.0-25 mg/L

You may not qualify if:

• current pregnancy or lactation
• smoking
• use of alcohol \> 1 drink per day (1 oz distilled liquor, 3 oz wine, 12 oz beer)
• reported history of cardiovascular disease or chronic inflammatory diseases
• current users of oral contraceptives
• lipid-lowering, anti-inflammatory, anti-coagulant, or thyroid medications
• currently drinking more than 4 glasses per day of orange or grapefruit juice

Sponsors & Collaborators

• USDA, Western Human Nutrition Research Center: lead
• The Beverage Institute for Health & Wellness: collaborator
• United States Department of Agriculture (USDA): collaborator

Study Sites (1)

USDA Western Human Nutrition Research Center

Davis, California, 95616, United States

Location

Related Links

• United States Department of Agriculture, Western Human Nutrition Research Center

MeSH Terms

Conditions

Hypercholesterolemia; Inflammation

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Darshan S Kelley, PhD

  USDA, Western Human Nutrition Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2013
• First Posted: December 13, 2013
• Study Start: April 1, 2007
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: December 13, 2013

Record last verified: 2013-12

Locations

US (1)