Rheumatoid ArthritisNCT02173587
Study Evaluating the Efficacy of Thick Shell Mussel Lipid Extract in Chinese Subjects With Rheumatoid Arthritis
A study testing Mussel oil capsules and Corn oil capsules in people with Rheumatoid Arthritis, run by Zhejiang University at 1 site in China.
Trial summary
Previous study found that lipid extract from hard-shelled mussel (HMLE) at a dose of 100mg/kg possessed strong anti-inflammatory activity by diminishing the hind paw swelling and arthritis index in rat model. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Mussel oil capsules and Corn oil capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- Feb 2014to Jul 2014
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- According to the American College of Rheumatology criteria, patients from Zhejiang province with active RA were included in this study and all participants were Chinese. Patients had at least 3 swollen joints and 6 tender joints or had an erythrocyte sedimentation rate (ESR) of >28mm/hr or morning stiffness of at least 45 min were classified as with active disease.
Who cannot join
- Subjects suffering hyperlipidemia, hyperglycemia, diabetes mellitus, cardiovascular diseases, gastrointestinal problems, liver and renal failure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Thick Shell Mussel Lipid Extract in Chinese Subjects With Rheumatoid Arthritis
Previous study found that lipid extract from hard-shelled mussel (HMLE) at a dose of 100mg/kg possessed strong anti-inflammatory activity by diminishing the hind paw swelling and arthritis index in rat model. In the present study, HMLE was processed to capsules under strict food safety supervision and patients with active rheumatoid arthritis (RA）were selected to examine whether supplementation with HMLE could improve clinical and laboratory parameters of disease activity. The validated disease activity score that include 28 joint counts and ESR (DAS28) and validated clinical disease activity index (CDAI) were primary outcome measure. Laboratory parameters including IL-1β, IL-6, IL-10, TNF-α,PGE2 and COX-2 were also measured to explore the mechanisms.
Read the detailed description
In this randomized controlled design, patients continued receiving background medications (slow-acting anti-rheumatic drugs and non-steroidal anti-inflammatory drugs) without change and were assigned to two groups. The first group (G1) received daily four mussel oil capsules (containing 800mg mussel oil and 800mg corn oil) for first two months and two mussel oil capsules per day thereafter. The second group (G2) received corn oil capsules (400mg corn oil per capsule) according to the same regimen. All patients were asked to keep a 7-day food diary before intervention and during wk 12. Dietary energy and nutrient intake of each subject during the preexperimental and study period were assessed from the dietary records by using "Diet Analysis" software (Cao Aihong, Taiyuan, China). All the enrolled patients visited Zhejiang Sir Run Run Shaw Hospital in the morning following an overnight fast at baseline and 3-month intervals, and underwent anthropometric measurements including height, body weight, waist circumference, hip circumference, heart rate and blood pressure. Then clinical evaluations were performed during face-to-face interview by a professional attending doctor and ten milliliter of peripheral venous blood was drawn. Serum and erythrocyte samples were also promptly processed and frozen at -80℃ until analysis.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Mussel oil capsules, Corn oil capsules
- Keywords
- Anti-inflammation, Rheumatoid arthritis, Thick shell mussel lipid extract, Chinese
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mussel oil capsulesDietary supplement
Also called lipid extract from hard-shelled mussel (Mytilus coruscus)
Each mussel oil capsule contained 200mg thick shell mussel lipid extract and 200mg corn oil.Each patient in this group received daily four mussel oil capsules (containing 800mg mussel oil and 800mg corn oil) for first two months and two mussel oil capsules per day thereafter
Corn oil capsulesDietary supplement
Also called Placebo comparator
Each corn oil capsule contained 400mg corn oil.Each patient in this group received daily four corn oil capsules (1600mg corn oil) for first two months and two corn oil capsules per day thereafter
| Study group | Role | What they receive |
|---|---|---|
| Mussel oil capsules | Experimental | Four mussel oil capsules (containing 800mg mussel oil and 800mg corn oil) per day for first two months and two mussel oil capsules (containing 400mg mussel oil and 400mg corn oil) per day thereafter for four months. Receives: Dietary Supplement: Mussel oil capsules |
| Corn oil capsuels | Placebo comparator | Four corn oil capsules (containing 1600mg corn oil) for first two months and two mussel oil capsules (containing 800mg corn oil) per day thereafter for four months. Receives: Dietary Supplement: Corn oil capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease activity score that include 28 joint counts and ESR (DAS28)
The validated disease activity score that include 28 joint counts and ESR (DAS28) were primary outcome measure. DAS28 was calculated as the formula: DAS28=[0.56*sqrt（T28）+0.28*sqrt（SW28）+0.70*Ln（ESR）]*1.08+0.16.
T28: Tender joint count; SW28: Swollen joint count; ESR: Erythrocyte sedimentation rate.
T28 and SW28 were determined by a professional doctor who was blind to the patient groups and ESR (Westergreen's method) was analyzed on Monitor 20 (VITAL Diagnostics, Italy).
Measured: Six months (3-month intervals)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2014 (estimated)
- Study startFeb 2014
- Primary completionJul 2014 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Sir Run Run Shaw Hospital
- Responsible party
- Principal investigator, Duo li, Zhejiang University
- Investigators
- Duo Li, Dr., Study director, Department of Food Science and Nutrition, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02173587
- Sponsor's protocol ID
- NNSFC81273064
- Status last verified
- Jun 2014
- First submitted
- 22 Jun 2014
- Last updated
- 25 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fu Y, Li G, Zhang X, Xing G, Hu X, Yang L, Li D. Lipid extract from hard-shelled mussel (Mytilus coruscus) improves clinical conditions of patients with rheumatoid arthritis: a randomized controlled trial. Nutrients. 2015 Jan 16;7(1):625-45. doi: 10.3390/nu7010625.
PubMed 25602164
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Thick Shell Mussel Lipid Extract in Chinese Subjects With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT02173587
- Acronym / sponsor ID
- NNSFC81273064
- Conditions
- Rheumatoid Arthritis
- Keywords
- Anti-inflammation, Rheumatoid arthritis, Thick shell mussel lipid extract, Chinese
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Sir Run Run Shaw Hospital
- Study start
- Feb 2014
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 25 Jun 2014 (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.
Previous study found that lipid extract from hard-shelled mussel (HMLE) at a dose of 100mg/kg possessed strong anti-inflammatory activity by diminishing the hind paw swelling and arthritis index in rat model. In the present study, HMLE was processed to capsules under strict food safety supervision and patients with active rheumatoid arthritis (RA）were selected to examine whether supplementation with HMLE could improve clinical and laboratory parameters of disease activity. The validated disease activity score that include 28 joint counts and ESR (DAS28) and validated clinical disease activity index (CDAI) were primary outcome measure. Laboratory parameters including IL-1β, IL-6, IL-10, TNF-α,PGE2 and COX-2 were also measured to explore the mechanisms.
Detailed description
In this randomized controlled design, patients continued receiving background medications (slow-acting anti-rheumatic drugs and non-steroidal anti-inflammatory drugs) without change and were assigned to two groups. The first group (G1) received daily four mussel oil capsules (containing 800mg mussel oil and 800mg corn oil) for first two months and two mussel oil capsules per day thereafter. The second group (G2) received corn oil capsules (400mg corn oil per capsule) according to the same regimen. All patients were asked to keep a 7-day food diary before intervention and during wk 12. Dietary energy and nutrient intake of each subject during the preexperimental and study period were assessed from the dietary records by using "Diet Analysis" software (Cao Aihong, Taiyuan, China). All the enrolled patients visited Zhejiang Sir Run Run Shaw Hospital in the morning following an overnight fast at baseline and 3-month intervals, and underwent anthropometric measurements including height, body weight, waist circumference, hip circumference, heart rate and blood pressure. Then clinical evaluations were performed during face-to-face interview by a professional attending doctor and ten milliliter of peripheral venous blood was drawn. Serum and erythrocyte samples were also promptly processed and frozen at -80℃ until analysis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mussel oil capsules | Experimental | Dietary Supplement: Mussel oil capsulesFour mussel oil capsules (containing 800mg mussel oil and 800mg corn oil) per day for first two months and two mussel oil capsules (containing 400mg mussel oil and 400mg corn oil) per day thereafter for four months. |
| Corn oil capsuels | Placebo comparator | Dietary Supplement: Corn oil capsulesFour corn oil capsules (containing 1600mg corn oil) for first two months and two mussel oil capsules (containing 800mg corn oil) per day thereafter for four months. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- According to the American College of Rheumatology criteria, patients from Zhejiang province with active RA were included in this study and all participants were Chinese. Patients had at least 3 swollen joints and 6 tender joints or had an erythrocyte sedimentation rate (ESR) of >28mm/hr or morning stiffness of at least 45 min were classified as with active disease.
Key exclusion criteria (1 listed)
- Subjects suffering hyperlipidemia, hyperglycemia, diabetes mellitus, cardiovascular diseases, gastrointestinal problems, liver and renal failure.
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 |
|---|---|---|
| Mussel oil capsulesAlso: lipid extract from hard-shelled mussel (Mytilus coruscus)Each mussel oil capsule contained 200mg thick shell mussel lipid extract and 200mg corn oil.Each patient in this group received daily four mussel oil capsules (containing 800mg mussel oil and 800mg corn oil) for first two months and two mussel oil capsules per day thereafter | Dietary supplement | Mussel oil capsules |
| Corn oil capsulesAlso: Placebo comparatorEach corn oil capsule contained 400mg corn oil.Each patient in this group received daily four corn oil capsules (1600mg corn oil) for first two months and two corn oil capsules per day thereafter | Dietary supplement | Corn oil capsuels |
Primary outcome
Disease activity score that include 28 joint counts and ESR (DAS28)
Time frame: Six months (3-month intervals)
The validated disease activity score that include 28 joint counts and ESR (DAS28) were primary outcome measure. DAS28 was calculated as the formula: DAS28=[0.56*sqrt（T28）+0.28*sqrt（SW28）+0.70*Ln（ESR）]*1.08+0.16. T28: Tender joint count; SW28: Swollen joint count; ESR: Erythrocyte sedimentation rate. T28 and SW28 were determined by a professional doctor who was blind to the patient groups and ESR (Westergreen's method) was analyzed on Monitor 20 (VITAL Diagnostics, Italy).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2014.
- Derived from this study: PubMed 25602164Fu Y, Li G, Zhang X, Xing G, Hu X, Yang L, Li D. Lipid extract from hard-shelled mussel (Mytilus coruscus) improves clinical conditions of patients with rheumatoid arthritis: a randomized controlled trial. Nutrients. 2015 Jan 16;7(1):625-45. doi: 10.3390/nu7010625.
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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.
Duo Li, Dr. study director
Department of Food Science and Nutrition, Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mussel oil capsules and Corn oil capsules in people with Rheumatoid Arthritis, run by Zhejiang University at 1 site in China.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 25 Jun 2014. 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 China. 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.
Are results available for this study?
Results are not available in the source record.
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?
Disease activity score that include 28 joint counts and ESR (DAS28) (time frame: Six months (3-month intervals)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02173587, which also lists 1 linked publication.
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 25 Jun 2014; AzTrials last refreshed its copy on 1 Nov 2026.