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

NCT02173587 | Unknown DMC

• 1 other identifier: NNSFC81273064
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rheumatoid Arthritis

Keywords

Anti-inflammation, Rheumatoid arthritis, Thick shell mussel lipid extract, Chinese

Outcome Measures

Primary Outcomes (1)

• 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)

Other Outcomes (7)

• C-reactive protein

  6 months (3-month intervals)

• Rheumatoid factor

  6 months (3-month intervals)

• Prostaglandin E2 (PGE2)

  6 months (3-month intervals)

Study Arms (2)

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.

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.

Dietary Supplement: Corn oil capsules

Interventions

Mussel oil capsules DIETARY_SUPPLEMENT

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

Also known as: lipid extract from hard-shelled mussel (Mytilus coruscus)

Mussel oil capsules

Corn oil capsules DIETARY_SUPPLEMENT

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

Also known as: Placebo comparator

Corn oil capsuels

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Zhejiang University: lead
• Sir Run Run Shaw Hospital: collaborator

Study Sites (1)

Zhejiang university

Hangzhou, Zhejiang, 310000, China

Location

Related Publications (1)

• 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.

  PMID: 25602164 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Corn Oil

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Duo Li, Dr.

  Department of Food Science and Nutrition, Zhejiang University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study director

Study Record Dates

• First Submitted: June 22, 2014
• First Posted: June 25, 2014
• Study Start: February 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: June 25, 2014

Record last verified: 2014-06

Locations

CN (1)