Dietary ModificationEarly Phase 1FRIEDNCT01175577
Feeding the Rainbow to Investigate Endothelial Dysfunction
A Early Phase 1 study testing Chlorophyll complex, Standard Process, Betatene, sold as "Full Spectrum Carotenoid Complex" and Small carotenoid-rich meals in people with Dietary Modification and Cardiovascular Disease, run by Bastyr University at 2 sites in United States.
Trial summary
The primary purpose of this study is to compare the change in blood carotene concentration between a food-based versus nutritional supplement-based intervention. This study will randomize up to 60 healthy volunteers to receive either carotenoid-enriched food; natural, mixed carotenoid supplementation; chlorophyll… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Modification, Cardiovascular Disease
- What is being tested?
- Chlorophyll complex, Standard Process, Betatene, sold as "Full Spectrum Carotenoid Complex" and Small carotenoid-rich meals
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2009to Aug 2011
- Phase
- Early Phase 1
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adults aged 18-65
- in good health by the absence of exclusion criteria on standardized medical history interview
- willingness to be randomized
- willingness to complete multiple blood draws following fast food consumption on two occasions over 28 days
Who cannot join
- children <18 years
- current use of carotenoid supplements (not including typical multivitamins containing beta-carotene)
- current use of polyphenol supplements including green tea, resveratrol, pine bark extract, cocoa, and/or grape skin extract
- current use of aspirin, statins or regular (>2 per week) use of NSAID medications
- current smoking or past smoking greater than 3 packs total or currently living with a smoker
- excessive alcohol intake (> 3 drinks per day) or history of alcoholism
Show all 23Show fewer
- known exposure to asbestos
- autoimmune disease
- hemachromatosis
- history of gallbladder disease including gall stones or gall bladder removal
- pre-diabetes, metabolic syndrome or diabetes (1 or 2)
- established cardiovascular disease (arrhythmia, heart failure, hypertension treatment or untreated stage II hypertension (≥160/90; stage II technically diastolic ≥100mmHg, will maintain diastolic cutoff of 90mmHg), past MI or stroke)
- renal or liver disease (viral hepatitis, non-alcoholic steatohepatitis "fatty liver")
- acute infection except viral colds
- residual injury/pain/limitation from trauma
- chronic musculoskeletal disorders including osteoarthritis requiring pain medications
- psychiatric disorders that would impair completion of research tasks
- allergies to supplied foods
- anyone on a medically-prescribed diet
- >3.5 servings fruits/veggies per day
- inability to consume entire study Control meal w/in specified timeline (30 minutes)
- current pregnancy or breast feeding
- refusal to participate in blood draws following the control meal.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Bastyr University Clinical Research Center
Kenmore, Washington, 98028
University of Washington Clinical Research Center
Seattle, Washington, 98195
About this study
Official title: Evaluating the Effects of Mixed-Carotenoids on Biomarkers of Endothelial Dysfunction
The primary purpose of this study is to compare the change in blood carotene concentration between a food-based versus nutritional supplement-based intervention. This study will randomize up to 60 healthy volunteers to receive either carotenoid-enriched food; natural, mixed carotenoid supplementation; chlorophyll complex or placebo supplementation. Blood carotene levels will be measured before and after 28 days of supplementation. Preliminary data will also be collected on several biomarkers associated with vascular inflammation and endothelial dysfunction. These biomarkers will be measured before and during a fast food control meal at the beginning and end of the intervention period.
- Conditions
- Dietary Modification, Cardiovascular Disease
- Being tested
- Chlorophyll complex, Standard Process, Betatene, sold as "Full Spectrum Carotenoid Complex", Small carotenoid-rich meals, Placebo
- Keywords
- mixed carotenes
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorophyll complex, Standard ProcessDietary supplement
One capsule, twice daily with meals for 28 days
Betatene, sold as "Full Spectrum Carotenoid Complex"Dietary supplement
One capsule per day with meals for 28 days
Small carotenoid-rich mealsOther
Single carotenoid-enriched soup or salad serving eaten daily
PlaceboOther
Safflower oil-filled capsules, one twice daily with meals
| Study group | Role | What they receive |
|---|---|---|
| Supplement 1 | Active comparator | Not described Receives: Dietary Supplement: Chlorophyll complex, Standard Process |
| Supplement 2 | Active comparator | Not described Receives: Dietary Supplement: Betatene, sold as "Full Spectrum Carotenoid Complex" |
| Food-based Intervention | Active comparator | Not described Receives: Other: Small carotenoid-rich meals |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum carotenoid fraction concentrations between study arms
Measured: Following 28 day intervention
Secondary outcomes (6)
Change in oxidized LDL lipoproteins (oxLDL)
Measured: Following 28 day intervention
Change in serum gamma-glutamyl transferase (GGT)
Measured: Following 28 day intervention
Change in urinary isoprostanes
Measured: Following 28 day intervention
Change in serum antioxidant capacity (ORAC)
Measured: Following 28 day intervention
Change in lipid profile (LDL, HDL, triglycerides)
Measured: Following 28 day intervention
Change in C-reactive protein (CRP)
Measured: Following 28 day intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2010 (estimated)
- Study startOct 2009
- Primary completionJun 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary ModificationStudies 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bastyr University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington
- Responsible party
- Principal investigator, Ryan David Bradley, Bastyr University
- Investigators
- Ryan D Bradley, ND, MPH, Principal investigator, Bastyr University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01175577
- Sponsor's protocol ID
- SP
- Acronym
- FRIED
- Status last verified
- Feb 2012
- First submitted
- 3 Aug 2010
- Last updated
- 3 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effects of Mixed-Carotenoids on Biomarkers of Endothelial Dysfunction
- ClinicalTrials.gov ID
- NCT01175577
- Acronym / sponsor ID
- FRIED / SP
- Conditions
- Dietary Modification, Cardiovascular Disease
- Keywords
- mixed carotenes
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bastyr UniversityUniversity, hospital or other
- Collaborators
- University of Washington
- Study start
- Oct 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 5 Aug 2010 (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 primary purpose of this study is to compare the change in blood carotene concentration between a food-based versus nutritional supplement-based intervention. This study will randomize up to 60 healthy volunteers to receive either carotenoid-enriched food; natural, mixed carotenoid supplementation; chlorophyll complex or placebo supplementation. Blood carotene levels will be measured before and after 28 days of supplementation. Preliminary data will also be collected on several biomarkers associated with vascular inflammation and endothelial dysfunction. These biomarkers will be measured before and during a fast food control meal at the beginning and end of the intervention period.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Supplement 1 | Active comparator | Dietary Supplement: Chlorophyll complex, Standard Process |
| Supplement 2 | Active comparator | Dietary Supplement: Betatene, sold as "Full Spectrum Carotenoid Complex" |
| Food-based Intervention | Active comparator | Other: Small carotenoid-rich meals |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adults aged 18-65
- in good health by the absence of exclusion criteria on standardized medical history interview
- willingness to be randomized
- willingness to complete multiple blood draws following fast food consumption on two occasions over 28 days
Key exclusion criteria (23 listed)
- children <18 years
- current use of carotenoid supplements (not including typical multivitamins containing beta-carotene)
- current use of polyphenol supplements including green tea, resveratrol, pine bark extract, cocoa, and/or grape skin extract
- current use of aspirin, statins or regular (>2 per week) use of NSAID medications
- current smoking or past smoking greater than 3 packs total or currently living with a smoker
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 |
|---|---|---|
| Chlorophyll complex, Standard ProcessOne capsule, twice daily with meals for 28 days | Dietary supplement | Supplement 1 |
| Betatene, sold as "Full Spectrum Carotenoid Complex"One capsule per day with meals for 28 days | Dietary supplement | Supplement 2 |
| Small carotenoid-rich mealsSingle carotenoid-enriched soup or salad serving eaten daily | Other | Food-based Intervention |
| PlaceboSafflower oil-filled capsules, one twice daily with meals | Other | Placebo |
Primary outcome
Change in serum carotenoid fraction concentrations between study arms
Time frame: Following 28 day intervention
6 secondary outcomes
Change in oxidized LDL lipoproteins (oxLDL)
Time frame: Following 28 day intervention
Change in serum gamma-glutamyl transferase (GGT)
Time frame: Following 28 day intervention
Change in urinary isoprostanes
Time frame: Following 28 day intervention
Change in serum antioxidant capacity (ORAC)
Time frame: Following 28 day intervention
Change in lipid profile (LDL, HDL, triglycerides)
Time frame: Following 28 day intervention
Change in C-reactive protein (CRP)
Time frame: Following 28 day intervention
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 3 Feb 2012.
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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.
Ryan D Bradley, ND, MPH principal investigator
Bastyr University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Chlorophyll complex, Standard Process, Betatene, sold as "Full Spectrum Carotenoid Complex" and Small carotenoid-rich meals in people with Dietary Modification and Cardiovascular Disease, run by Bastyr University at 2 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 4 inclusion and 23 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 3 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in serum carotenoid fraction concentrations between study arms (time frame: Following 28 day intervention). 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 3 Feb 2012.