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Metabolism And Health Effects Of Citrus Limonoids in Hypercholesterolemic Humans

NCT02011789 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2013-12-13

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Citrus Limonoid Beverage

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.

DIETARY_SUPPLEMENT

Placebo beverage

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

Sponsors & Collaborators

  • The Beverage Institute for Health & Wellness

    collaborator OTHER

  • United States Department of Agriculture (USDA)

    collaborator FED

  • USDA, Western Human Nutrition Research Center

    lead FED

Principal Investigators

  • Darshan S Kelley, PhD · USDA, Western Human Nutrition Research Center

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02011789 on ClinicalTrials.gov