Efficacy of a Dietary Ingredient Combination With Omega-3 for Joint Function (7DHA)

Universidad Católica San Antonio de Murcia

Status: Completed

Conditions: Joint Function Disorder

Treatments: Other: Control product consumption; Dietary Supplement: Omega-3 and/or botanical ingredient

Study type: Interventional

Funder types: Other

Identifiers

NCT05279573

UCAMCFE-00020

Details and patient eligibility

About

Randomized, controlled, double-blind intervention study of four parallel branches depending on the product consumed, to analyze the efficacy of an Omega-3 based product on the mobility and functionality of the evaluated joint.

Full description

The duration of the study will be 60 days (8 weeks). Each day they will have to consume the product under investigation. Subjects who meet the selection criteria will be randomized into each of the study groups (A, B, C o D, depending on the group in which they have been randomized). Each day the subjects will have to fill in a diary regarding pain and concomitant medication.

They will make a total of two visits to the research laboratory and will perform the tests pre-established in the protocol. In addition, a follow-up telephone call will be made after 30 days of consume. Subsequently, a statistical analysis will be performed with the variables measured in the study to obtain the results.

Enrollment: 130 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy adults (age: 40-75 YO).
• Subjects must have persistent knee pain with a baseline VAS pain assessment score of at least 30 mm.
• Subjects should not present narcotic drugs or steroidal anti-inflammatory drugs or immunosuppressants in their treatment.

Exclusion criteria

• Serious or terminal illnesses.
• Subjects currently taking glucosamine, chondroitin sulfate, collagen or hyaluronic infiltrations or any supplement indicated for joint health.
• Subjects who are currently consuming or have consumed in the last two months any Omega-3 based supplement and/or supplement based on the botanical ingredient under investigation.
• Subjects with chronic inflammatory diseases that affect the musculoskeletal system (rheumatoid arthritis, gout, pseudo-gout, Paget's disease, chronic pain syndrome, etc.).
• Subjects with a body mass index above 32.
• Subjects with known allergy to any of the study components.
• Pregnant or lactating women.
• Inability to understand informed consent.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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130 participants in 4 patient groups, including a placebo group

Combination of Omega-3 based product and botanical ingredient

Experimental group

Description:

Consumption for 60 days. Subjects should consume two capsules in the morning and two capsules in the afternoon.

Treatment:

Dietary Supplement: Omega-3 and/or botanical ingredient

Omega-3 based product

Experimental group

Description:

Consumption for 60 days. Subjects should consume two capsules in the morning and two capsules in the afternoon.

Treatment:

Dietary Supplement: Omega-3 and/or botanical ingredient

Botanical ingredient

Experimental group

Description:

Consumption for 60 days. Subjects should consume two capsules in the morning and two capsules in the afternoon.

Treatment:

Dietary Supplement: Omega-3 and/or botanical ingredient

Control group

Placebo Comparator group

Description:

Consumption for 60 days. Subjects should consume two capsules in the morning and two capsules in the afternoon.

Treatment:

Other: Control product consumption