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Sponsored by: |
Access Business Group |
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Information provided by: | Access Business Group |
ClinicalTrials.gov Identifier: | NCT00303238 |
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.
Condition | Intervention |
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Healthy |
Drug: Rose hips extract + blueberry/blackberry extract + resveravine Drug: Rose hips extract + blueberry/blackberry extract + Aframomum melegueta extract Drug: Rose hips extract + resveravine + Aframomum melegueta extract |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Double-Blind Trial to Evaluate the Effect of Botanical Dietary Supplements on C-Reactive Protein, Ex-Vivo IL-1 Production, and In-Vivo IL-1 Gene Expression in Healthy Human Subjects |
Estimated Enrollment: | 200 |
Study Start Date: | October 2004 |
Estimated Study Completion Date: | December 2005 |
The impact of nutrition and lifestyle have long been recognized as key determinants of risk for chronic degenerative diseases such as atherosclerosis, osteoporosis, rheumatoid arthritis, etc. While it is clear that reducing nutrition and lifestyle risk factors for a particular disease reduces risk in populations, individuals differ significantly in the degree to which presumed beneficial changes in these risk factors confer risk or lack thereof. This individual response is increasingly thought to be due genetic differences.
Developing in parallel with the research on genetic impact and chronic disease risk is a strengthening body of data suggesting that inflammation is common to many chronic degenerative diseases. A key cytokine regulator of the inflammatory response, interleukin-1 (IL-1), has emerged as playing a particularly important role at the genetic level in determining the degree to which the inflammation pathway is turned on. The strong influence of IL-1 over the inflammation pathway follows from its functional role as one of the initiating cytokine signals in the inflammatory pathway. Recent research has identified polymorphisms in the IL-1 gene that lead to over expression of IL-1 and elevated levels of the inflammation biomarker, c-reactive protein (CRP). Individuals with selected polymorphisms associated with over expression of IL-1 appear to be at increased risk for selected chronic degenerative diseases.
The mechanistic role of IL-1 in the overall inflammatory response and the detrimental impact of IL-1 over-expression may create a need for IL-1 genotype-directed nutritional, lifestyle and dietary supplement interventions that address the individual genetic risk for inflammation associated diseases by reducing chronic inflammation.
The current protocol draws participants from a pre-existing database containing information on health and lifestyle, IL-1 genotype, and inflammation biomarkers from approximately 2300 people. The database was created under a separate IRB-approved protocol. Participants will randomly receive one of three botanical formulas or a placebo once a day for 20 weeks. The effects of the botanical formulas on recognized markers of inflammation, e.g., CRP, as well as surrogate readouts of the inflammation pathway, ex vivo IL-1 production, and in vivo expression of the IL-1 gene will be evaluated.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Access Business Group, LLC | |
Buena Park, California, United States, 90622 | |
Southbay Pharma Research | |
Buena Park, California, United States, 90620 | |
National Institute of Clinical Research | |
Los Angeles, California, United States, 90017 | |
Providence Clinical Research | |
Burbank, California, United States, 91505 | |
Sall Research Medical Center | |
Artesia, California, United States, 90701 | |
United States, Massachusetts | |
East Coast Clinical Research | |
Haverhill, Massachusetts, United States, 01830 | |
United States, Michigan | |
Alticor, Inc | |
Ada, Michigan, United States, 49355 | |
United States, Rhode Island | |
Omega Medical Research | |
Warwick, Rhode Island, United States, 02886 |
Study Chair: | Russell K Randolph, PhD | Access Business Group, LLC |
Study Director: | Kenneth Kornman, PhD | Interleukin Genetics |
Study ID Numbers: | Lakeside 3a |
Study First Received: | March 14, 2006 |
Last Updated: | March 14, 2006 |
ClinicalTrials.gov Identifier: | NCT00303238 |
Health Authority: | United States: Institutional Review Board |
Inflammation Interleukin-1 C-reactive protein Genotype Rose Hips |
Blueberry Blackberry Aframomum melegueta Resveravine |
Healthy Inflammation |