NCT01175577

Brief Summary

The primary purpose of this study is to compare the change in blood carotene concentration between a food-based versus nutritional supplement-based intervention. This study will randomize up to 60 healthy volunteers to receive either carotenoid-enriched food; natural, mixed carotenoid supplementation; chlorophyll complex or placebo supplementation. Blood carotene levels will be measured before and after 28 days of supplementation. Preliminary data will also be collected on several biomarkers associated with vascular inflammation and endothelial dysfunction. These biomarkers will be measured before and during a fast food control meal at the beginning and end of the intervention period.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Oct 2009

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 5, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

February 3, 2012

Status Verified

February 1, 2012

Enrollment Period

1.7 years

First QC Date

August 3, 2010

Last Update Submit

February 2, 2012

Conditions

Dietary ModificationCardiovascular Disease

Keywords

mixed carotenes

Outcome Measures

Primary Outcomes (1)

  • Change in serum carotenoid fraction concentrations between study arms

    Following 28 day intervention

Secondary Outcomes (6)

  • Change in oxidized LDL lipoproteins (oxLDL)

    Following 28 day intervention

  • Change in serum gamma-glutamyl transferase (GGT)

    Following 28 day intervention

  • Change in urinary isoprostanes

    Following 28 day intervention

  • Change in serum antioxidant capacity (ORAC)

    Following 28 day intervention

  • Change in lipid profile (LDL, HDL, triglycerides)

    Following 28 day intervention

  • +1 more secondary outcomes

Study Arms (4)

Supplement 1

ACTIVE COMPARATOR
Dietary Supplement: Chlorophyll complex, Standard Process

Supplement 2

ACTIVE COMPARATOR
Dietary Supplement: Betatene, sold as "Full Spectrum Carotenoid Complex"

Food-based Intervention

ACTIVE COMPARATOR
Other: Small carotenoid-rich meals

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

Chlorophyll complex, Standard ProcessDIETARY_SUPPLEMENT

One capsule, twice daily with meals for 28 days

Supplement 1
Betatene, sold as "Full Spectrum Carotenoid Complex"DIETARY_SUPPLEMENT

One capsule per day with meals for 28 days

Supplement 2
Small carotenoid-rich mealsOTHER

Single carotenoid-enriched soup or salad serving eaten daily

Food-based Intervention
PlaceboOTHER

Safflower oil-filled capsules, one twice daily with meals

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adults aged 18-65

You may not qualify if:

  • willingness to be randomized
  • willingness to complete multiple blood draws following fast food consumption on two occasions over 28 days
  • children \<18 years
  • current use of carotenoid supplements (not including typical multivitamins containing beta-carotene)
  • current use of polyphenol supplements including green tea, resveratrol, pine bark extract, cocoa, and/or grape skin extract
  • current use of aspirin, statins or regular (\>2 per week) use of NSAID medications
  • current smoking or past smoking greater than 3 packs total or currently living with a smoker
  • excessive alcohol intake (\> 3 drinks per day) or history of alcoholism
  • known exposure to asbestos
  • autoimmune disease
  • hemachromatosis
  • history of gallbladder disease including gall stones or gall bladder removal
  • pre-diabetes, metabolic syndrome or diabetes (1 or 2)
  • established cardiovascular disease (arrhythmia, heart failure, hypertension treatment or untreated stage II hypertension (≥160/90; stage II technically diastolic ≥100mmHg, will maintain diastolic cutoff of 90mmHg), past MI or stroke)
  • renal or liver disease (viral hepatitis, non-alcoholic steatohepatitis "fatty liver")
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bastyr University Clinical Research Center

Kenmore, Washington, 98028, United States

Location

University of Washington Clinical Research Center

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Ryan D Bradley, ND, MPH

    Bastyr University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

August 3, 2010

First Posted

August 5, 2010

Study Start

October 1, 2009

Primary Completion

June 1, 2011

Study Completion

August 1, 2011

Last Updated

February 3, 2012

Record last verified: 2012-02

Locations

US(2)