NCT00303238

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (planned)
• Sponsor: Access Business Group · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Healthy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2004-10-01
• Completion: 2005-12-01
• First posted: 2006-03-16
• Last updated: 2006-03-16

Locations

8 sites across 1 country: United States