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

Joint Function Disorder Clinical Trial

— 7DHA  

Official title:

Randomized Controlled Intervention Study to Analyze the Efficacy of a Dietary Ingredient Combination With Omega-3 for Joint Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05279573
• Other study ID #: UCAMCFE-00020
• Status: Completed
• Phase: N/A
• Start date: February 14, 2022
• Est. completion date: December 23, 2022

Study information

• Verified date: November 2021
• Source: Universidad Católica San Antonio de Murcia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: December 23, 2022
• Est. primary completion date: November 29, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Joint Function Disorder

Intervention

Dietary Supplement:
• Omega-3 and/or botanical ingredient
Consumption for 60 days. Subjects should consume two capsules in the morning and two capsules in the afternoon.

Other:
• Control product consumption
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.

Locations

Country	Name	City	State
Spain	Catholic University of Murcia	Murcia

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Católica San Antonio de Murcia	Evonik Operations GmbH

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	Change in Pain from baseline at 8 weeks	Visual analog scale from 0 to 10. The higher the value, the more pain.	Pain will be measured with a daily scale, from baseline to 8 weeks.
Secondary	Functional test	The balance and mobility of the subjects will be measured with the Timed Up and Go Test	The test will be measured at baseline and after 8 weeks of consumption.
Secondary	Muscle function	Isokinetic and isometric dynamometry	The test will be measured at baseline and after 8 weeks of consumption.
Secondary	Change in concomitant analgesic medication	The change in the need for the use of analgesic medications will be evaluated	The test will be measured at baseline and after 8 weeks of consumption. It will also be evaluated on a daily basis
Secondary	Sleep efficiency	Measured by accelerometry, with Actigraph wGT3X-BT	The test will be measured at baseline and after 8 weeks of consumption. It will be measured during 3 weekdays and one weekend day.
Secondary	Sleep quality	Measured by Pittsburgh test	It will be measured twice, once at baseline or at the end of the study after 8 weeks of use
Secondary	Omega-3 Bioavailability	Measured by omega quant	It will be measured twice, once at baseline or at the end of the study after 8 weeks.
Secondary	Liver safety variables	It is a blood test that measures the presence of some enzymes, proteins and bilirubin in the blood, with the aim of determining if there is any alteration in the liver. Enzyme GPT, GOT, Gamma GT, LDH, alkaline phosphatase and bilirubin (UI/L)	It will be measured twice, once at baseline or at the end of the study after 8 weeks.
Secondary	Physical activity	It is a control variable. Measured by accelerometry, with Actigraph wGT3X-BT	The test will be measured at baseline and after 8 weeks of consumption. It will be measured during 3 weekdays and one weekend day.
Secondary	Physical activity control	It is a control variable. Measured by fitbit	The test will be measured at baseline and after 8 weeks of consumption.
Secondary	Body composition	It is a control variable. Measured by bioimpedance	The test will be measured at baseline and after 8 weeks of consumption.
Secondary	Waist - hip circumference	It is a control variable.	The test will be measured at baseline and after 8 weeks of consumption.