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Completed

NCT Number: NCT05279573

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.

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Key information

Conditions

Joint Function Disorder

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Catholic University of Murcia

Murcia, 30107, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in Pain from baseline at 8 weeks

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

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

  2. Quality of life test: WOMAC test

    Time frame: Change in initial quality of life at 8 weeks.

    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.

Secondary outcomes

  1. Change in Pain from baseline at 8 weeks

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

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

  2. Functional test

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

    The balance and mobility of the subjects will be measured with the Timed Up and Go Test

  3. Muscle function

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

    Isokinetic and isometric dynamometry

  4. Change in concomitant analgesic medication

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

    The change in the need for the use of analgesic medications will be evaluated

  5. Sleep efficiency

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

    Measured by accelerometry, with Actigraph wGT3X-BT

  6. Sleep quality

    Time frame: It will be measured twice, once at baseline or at the end of the study after 8 weeks of use

    Measured by Pittsburgh test

  7. Omega-3 Bioavailability

    Time frame: It will be measured twice, once at baseline or at the end of the study after 8 weeks.

    Measured by omega quant

  8. Liver safety variables

    Time frame: It will be measured twice, once at baseline or at the end of the study after 8 weeks.

    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)

  9. Physical activity

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

    It is a control variable. Measured by accelerometry, with Actigraph wGT3X-BT

  10. Physical activity control

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

    It is a control variable. Measured by fitbit

  11. Body composition

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

    It is a control variable. Measured by bioimpedance

  12. Waist - hip circumference

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

    It is a control variable.

Sponsors and collaborators

Lead sponsor

Universidad Católica San Antonio de Murcia

Other

Collaborators

  • Evonik Operations GmbH

Registry information

Official study title

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

Acronym: 7DHA

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 15, 2022
Registry last updated
Dec 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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