HealthyNCT00303238
Study to Evaluate the Effect of Botanical Dietary Supplements on Inflammation in Healthy People
A study testing Rose hips extract + blueberry/blackberry extract + resveravine, Rose hips extract + blueberry/blackberry extract + Aframomum melegueta extract and Rose hips extract + resveravine + Aframomum melegueta extract in people with Healthy, run by Access Business Group at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Rose hips extract + blueberry/blackberry extract + resveravine, Rose hips extract + blueberry/blackberry extract + Aframomum melegueta extract and Rose hips extract + resveravine + Aframomum melegueta extract
- How many people
- 200 participants
- Where
- 8 sitesUnited States
- Study dates
- Oct 2004to Dec 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Alticor, Inc
Ada, Michigan, 49355
Sall Research Medical Center
Artesia, California, 90701
Southbay Pharma Research
Buena Park, California, 90620
Access Business Group, LLC
Buena Park, California, 90622
Providence Clinical Research
Burbank, California, 91505
East Coast Clinical Research
Haverhill, Massachusetts, 01830
National Institute of Clinical Research
Los Angeles, California, 90017
Omega Medical Research
Warwick, Rhode Island, 02886
About this 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
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.
Read the 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
- Being tested
- Rose hips extract + blueberry/blackberry extract + resveravine, Rose hips extract + blueberry/blackberry extract + Aframomum melegueta extract, Rose hips extract + resveravine + Aframomum melegueta extract
- Keywords
- Inflammation, Interleukin-1, C-reactive protein, Genotype, Rose Hips, Blueberry, Blackberry, Aframomum melegueta, Resveravine
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rose hips extract + blueberry/blackberry extract + resveravineDrug
Rose hips extract + blueberry/blackberry extract + Aframomum melegueta extractDrug
Rose hips extract + resveravine + Aframomum melegueta extractDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
- 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2006 (estimated)
- Study startOct 2004
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Access Business Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Russell K Randolph, PhD, Study chair, Access Business Group, LLCKenneth Kornman, PhD, Study director, Interleukin Genetics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00303238
- Sponsor's protocol ID
- Lakeside 3a
- Status last verified
- Mar 2006
- First submitted
- 14 Mar 2006
- Last updated
- 16 Mar 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00303238
- Acronym / sponsor ID
- Lakeside 3a
- Conditions
- Healthy
- Keywords
- Inflammation, Interleukin-1, C-reactive protein, Genotype, Rose Hips, Blueberry, Blackberry, Aframomum melegueta
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- Access Business GroupIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Study completion
- Dec 2005
- First posted
- 16 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | – |
Primary outcome
- Serum C-reactive protein levels
- In vivo IL-1 gene expression
- Ex vivo IL-1 production
4 secondary outcomes
- 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Russell K Randolph, PhD study chair
Access Business Group, LLC
Kenneth Kornman, PhD study director
Interleukin Genetics
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rose hips extract + blueberry/blackberry extract + resveravine, Rose hips extract + blueberry/blackberry extract + Aframomum melegueta extract and Rose hips extract + resveravine + Aframomum melegueta extract in people with Healthy, run by Access Business Group at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
- Serum C-reactive protein levels. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2006.