Efficacy of a Dietary Ingredient Combination With Omega-3 for Joint Function

NCT05279573 | Completed

• 1 other identifier: UCAMCFE-00020
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Joint Function Disorder

Keywords

Omega-3

Outcome Measures

Primary Outcomes (2)

• Change in Pain from baseline at 8 weeks

  Visual analog scale from 0 to 10. The higher the value, the more pain.

  The evolution of pain after consumption during 8 weeks will be measured.

• Quality of life test: WOMAC test

  The quality of life of the subjects will be measured with the WOMAC test. It is a 24-item test that will measure the degree of pain: nothing, little, enough and a lot, when performing activities in daily life.

  Change in initial quality of life at 8 weeks.

Secondary Outcomes (12)

• Change in Pain from baseline at 8 weeks

  Pain will be measured with a daily scale, from baseline to 8 weeks.

• Functional test

  The test will be measured at baseline and after 8 weeks of consumption.

• Muscle function

  The test will be measured at baseline and after 8 weeks of consumption.

• Change in concomitant analgesic medication

  The test will be measured at baseline and after 8 weeks of consumption. It will also be evaluated on a daily basis

• Sleep efficiency

  The test will be measured at baseline and after 8 weeks of consumption. It will be measured during 3 weekdays and one weekend day.

Study Arms (4)

Combination of Omega-3 based product and botanical ingredient

EXPERIMENTAL

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

Dietary Supplement: Omega-3 and/or botanical ingredient

Omega-3 based product

EXPERIMENTAL

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

Dietary Supplement: Omega-3 and/or botanical ingredient

Botanical ingredient

EXPERIMENTAL

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

Dietary Supplement: Omega-3 and/or botanical ingredient

Control group

PLACEBO COMPARATOR

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

Other: Control product consumption

Interventions

Omega-3 and/or botanical ingredient DIETARY_SUPPLEMENT

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

Botanical ingredient; Combination of Omega-3 based product and botanical ingredient; Omega-3 based product

Control product consumption OTHER

Product with identical characteristics to the experimental product. Consumption for 60 days. Subjects should consume two capsules in the morning and two capsules in the afternoon.

Control group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Católica San Antonio de Murcia: lead
• Evonik Operations GmbH: collaborator

Study Sites (1)

Catholic University of Murcia

Murcia, 30107, Spain

Location

Study Officials

• Fco Javier López Roman

  Catholic University of Murcia

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 22, 2022
• First Posted: March 15, 2022
• Study Start: February 14, 2022
• Primary Completion: November 29, 2022
• Study Completion: December 23, 2022
• Last Updated: December 28, 2022

Record last verified: 2021-11

Locations

ES (1)