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

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

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.

Study Overview

• Status: Completed
• Conditions: Joint Function Disorder
• Intervention / Treatment: Dietary supplement: Omega-3 and/or botanical ingredient; Other: Control product consumption

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Murcia, Spain, 30107
    • Catholic University of Murcia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Combination of Omega-3 based product and botanical ingredient; 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; Consumption for 60 days. Subjects should consume two capsules in the morning and two capsules in the afternoon.
Experimental: Omega-3 based product; 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; Consumption for 60 days. Subjects should consume two capsules in the morning and two capsules in the afternoon.
Experimental: Botanical ingredient; 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; Consumption for 60 days. Subjects should consume two capsules in the morning and two capsules in the afternoon.
Placebo Comparator: Control group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
Muscle function	Isokinetic and isometric dynamometry	The test will be measured at baseline and after 8 weeks of consumption.
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
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.
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
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.
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.
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.
Physical activity control	It is a control variable. Measured by fitbit	The test will be measured at baseline and after 8 weeks of consumption.
Body composition	It is a control variable. Measured by bioimpedance	The test will be measured at baseline and after 8 weeks of consumption.
Waist - hip circumference	It is a control variable.	The test will be measured at baseline and after 8 weeks of consumption.

Collaborators and Investigators

• Sponsor: Universidad Católica San Antonio de Murcia
• Collaborators: Evonik Operations GmbH
• Investigators: Principal Investigator: Fco Javier López Román, Catholic University of Murcia

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2022
• Primary Completion (Actual): November 29, 2022
• Study Completion (Actual): December 23, 2022

Study Registration Dates

• First Submitted: February 22, 2022
• First Submitted That Met QC Criteria: March 6, 2022
• First Posted (Actual): March 15, 2022

Study Record Updates

• Last Update Posted (Actual): December 28, 2022
• Last Update Submitted That Met QC Criteria: December 24, 2022
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Omega-3
• Other Study ID Numbers: UCAMCFE-00020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No