PsoriasisPhase 1PCANCT01045395
Efficacy of Two Algae Formulations on Lipid Metabolism, Inflammation and Oxidative Stress Status in Individuals With Psoriasis
A Phase 1 study testing Corn starch, Unique Marine Algae Concentrate (UMAC) and Golden brown algae in people with Psoriasis, run by University of Manitoba at 1 site in Canada.
Trial summary
Our overall goal is to evaluate the safety and efficacy of consumption of two algae formulations compared to a placebo on: degree of severity of skin lesions, plasma lipid levels, as well as other health-related markers, in individuals with clinically diagnosed psoriasis. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- What is being tested?
- Corn starch, Unique Marine Algae Concentrate (UMAC) and Golden brown algae
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2009to Nov 2010
- Phase
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females with clinically diagnosed psoriasis
- Plasma LDL-C 80-190 mg/dL, and TG levels below 400 mg/dL.
- Body mass index (BMI) range will be 22 to 32 kg/m2.
- Subjects must demonstrate an ability to understand dietary procedures and be judged as compliant and motivated by the investigators.
- Subjects will be permitted to take stable doses of medications (including drugs for thyroid disease and hypertension)will be permitted if the dose level is maintained stable throughout the study.
- potential subjects must have stable psoriasis and their treatments must remain constant throughout the study.
Who cannot join
- recent (i.e. less than 3 mo) or chronic use of oral hypolipidemic therapy, including fish oils, or probucol within the last 6 mo
- history of chronic use of alcohol (>2 drinks/d), systemic antibodies, corticosteroids, androgens, or phenytoin
- subjects on anticoagulant therapy (such as warfarin), taking medications and/or natural health products known to affect lipid metabolism (cholestyramine, colestipol, niacin, clofibrate, gemfibrozil, probucol, HMG CoA reductase inhibitors, high dose dietary supplements or fish oil capsules (>4g/day), guggul, lecithin, evening primrose oil within the last six month period will be excluded. In addition, subjects will not be allowed to consume any of these medications during the study
- myocardial infarction, coronary artery bypass, or other major surgical procedures within the last six months
- recent onset and any history of angina, congestive heart failure, heart disease, inflammatory bowel disease, pancreatitis, diabetes, lactose intolerance gastrointestinal, renal, pulmonary, hepatic or biliary disease, or cancer
- moderate or high risk for CAD
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- uncontrolled hypertension defined as untreated systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg
- pregnant, breastfeeding, or planning to become pregnant during the course of the trial
- bleeding disorder, anemia, or significant recent blood loss/donation
- allergy/sensitivity to any of the ingredients in the study product or placebo
- chronic user of algal products, fiber laxative (greater than 2 doses/wk), or stimulant laxatives or has a history of eating disorders, exercise greater than 15 miles/wk or 4,000 kcal/wk.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Ricahrson Centre for Functionl Foods and Nutraceuticals, U of M
Winnipeg, Manitoba
About this study
Our overall goal is to evaluate the safety and efficacy of consumption of two algae formulations compared to a placebo on: degree of severity of skin lesions, plasma lipid levels, as well as other health-related markers, in individuals with clinically diagnosed psoriasis.
- Conditions
- Psoriasis
- Being tested
- Corn starch, Unique Marine Algae Concentrate (UMAC), Golden brown algae
- Keywords
- Algae, Psoriasis, Lipid metabolism, Inflammation, Oxidative stress
- Medical subject headings
- Psoriasis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corn starchDietary supplement
90mg/d
Unique Marine Algae Concentrate (UMAC)Dietary supplement
90mg/d
Golden brown algaeDietary supplement
90mg/d
| Study group | Role | What they receive |
|---|---|---|
| Corn starch, 90mg/d | Placebo comparator | Corn starch, 90mg/d Receives: Dietary Supplement: Corn starch |
| Unique Marine Algae Concentrate (UMAC). 90mg/d | Experimental | Not described Receives: Dietary Supplement: Unique Marine Algae Concentrate (UMAC) |
| Golden brown algae, 90mg/d | Experimental | Not described Receives: Dietary Supplement: Golden brown algae |
What is being measured
The primary outcome is the main question the study is designed to answer.
A photographic documentation will be carried out quantifying lesion size over at least two body sites. A subjective questionnaire will also be provided to volunteers to enable self-reported evaluation of the extent and degree of discomfort of lesions.
Measured: at the beginning and end of each of the three intervention periods
Total cholesterol, LDL- cholesterol, HDL-cholesterol and Triglycerides in plasma, will be determined.
Measured: at the beginning and the end of each phase
Secondary outcomes (1)
Vascular cell adhesion molecule-1 (VCAM-1), E-selectin, interleukin-6 (IL-6), IL-10, soluble tumour necrosis factor receptor 2 (sTNFR-2) and soluble cell adhesion molecules (sICAM-1 and sVCAM-1) will be assessed. Lipid peroxidation will also be measured.
Measured: at the beginning and the end of each phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2010 (estimated)
- Study startSep 2009
- Primary completionJun 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01045395
- Sponsor's protocol ID
- B2008:139
- Acronym
- PCA
- Status last verified
- Jan 2010
- First submitted
- 7 Jan 2010
- Last updated
- 16 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Two Algae Formulations on Lipid Metabolism, Inflammation and Oxidative Stress Status in Individuals With Psoriasis
- ClinicalTrials.gov ID
- NCT01045395
- Acronym / sponsor ID
- PCA / B2008:139
- Conditions
- Psoriasis
- Keywords
- Algae, Psoriasis, Lipid metabolism, Inflammation, Oxidative stress
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 11 Jan 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.
Our overall goal is to evaluate the safety and efficacy of consumption of two algae formulations compared to a placebo on: degree of severity of skin lesions, plasma lipid levels, as well as other health-related markers, in individuals with clinically diagnosed psoriasis.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Corn starch, 90mg/d | Placebo comparator | Dietary Supplement: Corn starchCorn starch, 90mg/d |
| Unique Marine Algae Concentrate (UMAC). 90mg/d | Experimental | Dietary Supplement: Unique Marine Algae Concentrate (UMAC) |
| Golden brown algae, 90mg/d | Experimental | Dietary Supplement: Golden brown algae |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Males and females with clinically diagnosed psoriasis
- Plasma LDL-C 80-190 mg/dL, and TG levels below 400 mg/dL.
- Body mass index (BMI) range will be 22 to 32 kg/m2.
- Subjects must demonstrate an ability to understand dietary procedures and be judged as compliant and motivated by the investigators.
- Subjects will be permitted to take stable doses of medications (including drugs for thyroid disease and hypertension)will be permitted if the dose level is maintained stable throughout the study.
Key exclusion criteria (11 listed)
- recent (i.e. less than 3 mo) or chronic use of oral hypolipidemic therapy, including fish oils, or probucol within the last 6 mo
- history of chronic use of alcohol (>2 drinks/d), systemic antibodies, corticosteroids, androgens, or phenytoin
- subjects on anticoagulant therapy (such as warfarin), taking medications and/or natural health products known to affect lipid metabolism (cholestyramine, colestipol, niacin, clofibrate, gemfibrozil, probucol, HMG CoA reductase inhibitors, high dose dietary supplements or fish oil capsules (>4g/day), guggul, lecithin, evening primrose oil within the last six month period will be excluded. In addition, subjects will not be allowed to consume any of these medications during the study
- myocardial infarction, coronary artery bypass, or other major surgical procedures within the last six months
- recent onset and any history of angina, congestive heart failure, heart disease, inflammatory bowel disease, pancreatitis, diabetes, lactose intolerance gastrointestinal, renal, pulmonary, hepatic or biliary disease, or cancer
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 |
|---|---|---|
| Corn starch90mg/d | Dietary supplement | Corn starch, 90mg/d |
| Unique Marine Algae Concentrate (UMAC)90mg/d | Dietary supplement | Unique Marine Algae Concentrate (UMAC). 90mg/d |
| Golden brown algae90mg/d | Dietary supplement | Golden brown algae, 90mg/d |
Primary outcome
A photographic documentation will be carried out quantifying lesion size over at least two body sites. A subjective questionnaire will also be provided to volunteers to enable self-reported evaluation of the extent and degree of discomfort of lesions.
Time frame: at the beginning and end of each of the three intervention periods
Total cholesterol, LDL- cholesterol, HDL-cholesterol and Triglycerides in plasma, will be determined.
Time frame: at the beginning and the end of each phase
1 secondary outcome
Vascular cell adhesion molecule-1 (VCAM-1), E-selectin, interleukin-6 (IL-6), IL-10, soluble tumour necrosis factor receptor 2 (sTNFR-2) and soluble cell adhesion molecules (sICAM-1 and sVCAM-1) will be assessed. Lipid peroxidation will also be measured.
Time frame: at the beginning and the end of each phase
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 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Corn starch, Unique Marine Algae Concentrate (UMAC) and Golden brown algae in people with Psoriasis, run by University of Manitoba at 1 site in Canada.
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 11 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 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
A photographic documentation will be carried out quantifying lesion size over at least two body sites. A subjective questionnaire will also be provided to volunteers to enable self-reported evaluation of the extent and degree of discomfort of lesions. (time frame: at the beginning and end of each of the three intervention periods). The study lists 2 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 2011.