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

• Status: Completed
• Trial end date: 2005-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Access Business Group

Criteria

Inclusion Criteria:

1. Non-smoking adults aged 18 and up

2. Individual should be judged to be in good general health on the basis of an interview, vitals assessment, and physical examination

3. Individual is willing to maintain their normal dietary and exercise habits throughout the duration of the trial

4. Individual understands the procedures and agrees to participate in the study

5. Individual is able and willing to provide written informed consent

6. Average serum CRP level between 2 and 10 mg/L inclusively.

Exclusion Criteria:

1. Current smoker or history of tobacco use within the past year

2. Use of dietary supplements within one week of Day 1. Supplements include any vitamins, minerals, and herbal products, including herbal drinks

3. 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

4. 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

5. 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

6. Therapeutic use of coumadin, aspirin, or other medications that influence blood coagulation

7. Current use of NSAIDS, including COX-2 inhibitors

8. 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

9. Known allergy to rose hips, blueberries, blackberries, resveravine, and/or A. melegueta

10. Current use of any form of steroid drug (prescription or non-prescription), including inhalers for asthma

11. Current use of any form of hormone replacement therapy (HRT and ERT)

12. Participation in another clinical trial within 30 days of enrollment into the study

13. History or current abuse of drugs or alcohol, or intake > 2 alcoholic beverages per day

14. Pregnant or lactating women, or women of child-bearing potential unwilling to use a medically approved form of birth control

15. Any condition that the Principal Investigator believes may put the subject at undue risk

16. 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