NCT00303238

Brief Summary

The purpose of the study is to evaluate the effect of botanical dietary supplements on inflammation in healthy people with different genetic responses to inflammation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Oct 2004

Typical duration for not_applicable healthy

Geographic Reach
1 country

8 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 16, 2006

Completed
Last Updated

March 16, 2006

Status Verified

March 1, 2006

First QC Date

March 14, 2006

Last Update Submit

March 14, 2006

Conditions

Healthy

Keywords

InflammationInterleukin-1C-reactive proteinGenotypeRose HipsBlueberryBlackberryAframomum meleguetaResveravine

Outcome Measures

Primary Outcomes (3)

  • - Serum C-reactive protein levels

  • - In vivo IL-1 gene expression

  • - Ex vivo IL-1 production

Secondary Outcomes (4)

  • - Cytokine Inflammatory Panel (IL-1-alpha, TNF-alpha, IL-6, IL-8, IL-10, and IL-12)

  • - Serum Amyloid A (SAA)

  • - Serum Intracellular Adhesion Molecule-1 (ICAM-1)

  • - Fibrinogen

Interventions

Rose hips extract + blueberry/blackberry extract + resveravineDRUG
Rose hips extract + blueberry/blackberry extract + Aframomum melegueta extractDRUG
Rose hips extract + resveravine + Aframomum melegueta extractDRUG

Eligibility Criteria

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

You may qualify if:

  • Non-smoking adults aged 18 and up
  • Individual should be judged to be in good general health on the basis of an interview, vitals assessment, and physical examination
  • Individual is willing to maintain their normal dietary and exercise habits throughout the duration of the trial
  • Individual understands the procedures and agrees to participate in the study
  • Individual is able and willing to provide written informed consent
  • Average serum CRP level between 2 and 10 mg/L inclusively.

You may not qualify if:

  • Current smoker or history of tobacco use within the past year
  • Use of dietary supplements within one week of Day 1. Supplements include any vitamins, minerals, and herbal products, including herbal drinks
  • Presence of, or clinical significant history of, autoimmune, blood, cancer, cardiovascular, endocrine, kidney, liver, lung, gastrointestinal, metabolic disorder, and/or any other chronic health condition identified from the findings of the interview
  • Currently treated for uncontrolled hypertension or blood pressure \> 170 mm Hg systolic or \> 100 mm Hg diastolic during seated, resting measurement on two consecutive occasions during visit 1
  • Therapeutic use of nitroglycerin, alpha1- or beta-adrenergic blockers, Apresoline, Loniten, calcium channel blockers, ACE inhibitors, and/or any other drug that may alter blood pressure
  • Therapeutic use of coumadin, aspirin, or other medications that influence blood coagulation
  • Current use of NSAIDS, including COX-2 inhibitors
  • Therapeutic use of cholesterol-lowering medications such as HMG CoA reductase inhibitors, bile acid binding agents, bile acid binding resins, nicotinic acid, and fibric acid derivatives
  • Known allergy to rose hips, blueberries, blackberries, resveravine, and/or A. melegueta
  • Current use of any form of steroid drug (prescription or non-prescription), including inhalers for asthma
  • Current use of any form of hormone replacement therapy (HRT and ERT)
  • Participation in another clinical trial within 30 days of enrollment into the study
  • History or current abuse of drugs or alcohol, or intake \> 2 alcoholic beverages per day
  • Pregnant or lactating women, or women of child-bearing potential unwilling to use a medically approved form of birth control
  • Any condition that the Principal Investigator believes may put the subject at undue risk
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Sall Research Medical Center

Artesia, California, 90701, United States

Location

Southbay Pharma Research

Buena Park, California, 90620, United States

Location

Access Business Group, LLC

Buena Park, California, 90622, United States

Location

Providence Clinical Research

Burbank, California, 91505, United States

Location

National Institute of Clinical Research

Los Angeles, California, 90017, United States

Location

East Coast Clinical Research

Haverhill, Massachusetts, 01830, United States

Location

Alticor, Inc

Ada, Michigan, 49355, United States

Location

Omega Medical Research

Warwick, Rhode Island, 02886, United States

Location

MeSH Terms

Conditions

Inflammation

Interventions

blueberry extract

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Russell K Randolph, PhD

    Access Business Group, LLC

    STUDY CHAIR

  • Kenneth Kornman, PhD

    Interleukin Genetics

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 14, 2006

First Posted

March 16, 2006

Study Start

October 1, 2004

Study Completion

December 1, 2005

Last Updated

March 16, 2006

Record last verified: 2006-03

Locations

US(8)