Study Evaluating the Efficacy of Thick Shell Mussel Lipid Extract in Chinese Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

Efficacy of Thick Shell Mussel Lipid Extract in Chinese Subjects With Rheumatoid Arthritis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02173587
• Other study ID #: NNSFC81273064
• Status: Active, not recruiting
• Phase: N/A
• First received: June 22, 2014
• Last updated: June 23, 2014
• Start date: February 2014
• Est. completion date: July 2014

Study information

• Verified date: June 2014
• Source: Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 56
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Subjects suffering hyperlipidemia, hyperglycemia, diabetes mellitus, cardiovascular diseases, gastrointestinal problems, liver and renal failure.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Dietary Supplement:
• Mussel oil capsules
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 capsules
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

Locations

Country	Name	City	State
China	Zhejiang university	Hangzhou	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
Zhejiang University	Sir Run Run Shaw Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	C-reactive protein	Fasting blood specimens were obtained from all participants at entry, 12 and 24 wk later. C-reactive protein was analyzed on HITACHI 7020 chemistry analyzer using enzymebased colorimetric test or colorimetric test supplied by DiaSys Diagnostic Systems (Shanghai) Co., Ltd. within four hours of blood collection.	6 months (3-month intervals)	No
Other	Rheumatoid factor	Fasting blood specimens were obtained from all participants at entry, 12 and 24 wk later.Rheumatoid factor were analyzed on HITACHI 7020 chemistry analyzer using enzymebased colorimetric test or colorimetric test supplied by DiaSys Diagnostic Systems (Shanghai) Co., Ltd. within four hours of blood collection.	6 months (3-month intervals)	No
Other	Prostaglandin E2 (PGE2)	Levels of PGE2 from serum were determined by the research workers who were blind to the patient groups using ELISA Kits (Nanjing Jiancheng Technology Co., Lte., Nanjing, China), according to the manufacturer's instructions.	6 months (3-month intervals)	No
Other	Interleukin-1ß(IL-1ß)	Levels of IL-1ß from serum were determined by the research workers who were blind to the patient groups using ELISA Kits (Nanjing Jiancheng Technology Co., Lte., Nanjing, China), according to the manufacturer's instructions.	6 months (3-month intervals)	No
Other	Tumor necrosis factor-a (TNF-a)	Levels of TNF-a from serum were determined by the research workers who were blind to the patient groups using ELISA Kits (Nanjing Jiancheng Technology Co., Lte., Nanjing, China), according to the manufacturer's instructions.	6 months (3-month intervals)	No
Other	Interleukin-6 (IL-6)	Levels of IL-6 from serum were determined by the research workers who were blind to the patient groups using ELISA Kits (Nanjing Jiancheng Technology Co., Lte., Nanjing, China), according to the manufacturer's instructions.	6 months (3-month intervals)	No
Other	Interleukin-10 (IL-10)	Levels IL-10 from serum were determined by the research workers who were blind to the patient groups using ELISA Kits (Nanjing Jiancheng Technology Co., Lte., Nanjing, China), according to the manufacturer's instructions.	6 months (3-month intervals)	No
Primary	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).	Six months (3-month intervals)	No