Study to Evaluate the Effect of Botanical Dietary Supplements on Inflammation in Healthy People

Completed · Not applicable

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT00303238

Run by

Access Business Group

People needed

200

Starts

2004-10-01

Expected to finish

2005-12-01

Last updated by the study team

2006-03-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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
• Serum CRP less than 3 or higher than 10 mg/L. If a subject has a CRP > 10 mg/L at screening, the measurement will be repeated two weeks later to determine whether the subject should be excluded from the protocol

Where it is running

• Sall Research Medical Center — Artesia, California, United States
• Southbay Pharma Research — Buena Park, California, United States
• Access Business Group, LLC — Buena Park, California, United States
• Providence Clinical Research — Burbank, California, United States
• National Institute of Clinical Research — Los Angeles, California, United States
• East Coast Clinical Research — Haverhill, Massachusetts, United States
• Alticor, Inc — Ada, Michigan, United States
• Omega Medical Research — Warwick, Rhode Island, United States

Full record on ClinicalTrials.gov

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