Joint Function Disorder7DHANCT05279573
Efficacy of a Dietary Ingredient Combination With Omega-3 for Joint Function
A study testing Omega-3 and/or botanical ingredient in people with Joint Function Disorder, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Joint Function Disorder
- What is being tested?
- Omega-3 and/or botanical ingredient
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteSpain
- Study dates
- 14 Feb 2022to 23 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Joint Function Disorder
- Being tested
- Omega-3 and/or botanical ingredient, Control product consumption
- Keywords
- Omega-3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 and/or botanical ingredientDietary supplement
Consumption for 60 days. Subjects should consume two capsules in the morning and two capsules in the afternoon.
Control product consumptionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Control product consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain from baseline at 8 weeks
Visual analog scale from 0 to 10. The higher the value, the more pain.
Measured: 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.
Measured: Change in initial quality of life at 8 weeks.
Secondary outcomes (12)
Change in Pain from baseline at 8 weeks
Visual analog scale from 0 to 10. The higher the value, the more pain.
Measured: 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
Measured: The test will be measured at baseline and after 8 weeks of consumption.
Muscle function
Isokinetic and isometric dynamometry
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: The test will be measured at baseline and after 8 weeks of consumption.
Body composition
It is a control variable. Measured by bioimpedance
Measured: The test will be measured at baseline and after 8 weeks of consumption.
Waist - hip circumference
It is a control variable.
Measured: The test will be measured at baseline and after 8 weeks of consumption.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start14 Feb 2022
- Primary completion29 Nov 2022
- Study completion23 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Joint Function DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Collaborators
- Evonik Operations GmbH
- Responsible party
- Principal investigator, Francisco Javier López Román, Universidad Católica San Antonio de Murcia
- Investigators
- Fco Javier López Roman, Principal investigator, Catholic University of Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05279573
- Sponsor's protocol ID
- UCAMCFE-00020
- Acronym
- 7DHA
- Status last verified
- Nov 2021
- First submitted
- 22 Feb 2022
- Last updated
- 28 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Intervention Study to Analyze the Efficacy of a Dietary Ingredient Combination With Omega-3 for Joint Function
- ClinicalTrials.gov ID
- NCT05279573
- Acronym / sponsor ID
- 7DHA / UCAMCFE-00020
- Conditions
- Joint Function Disorder
- Keywords
- Omega-3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Collaborators
- Evonik Operations GmbH
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- 29 Nov 2022 (actual)
- Study completion
- 23 Dec 2022 (actual)
- First posted
- 15 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Combination of Omega-3 based product and botanical ingredient | Experimental | Dietary Supplement: Omega-3 and/or botanical ingredientConsumption for 60 days. Subjects should consume two capsules in the morning and two capsules in the afternoon. |
| Omega-3 based product | Experimental | Dietary Supplement: Omega-3 and/or botanical ingredientConsumption for 60 days. Subjects should consume two capsules in the morning and two capsules in the afternoon. |
| Botanical ingredient | Experimental | Dietary Supplement: Omega-3 and/or botanical ingredientConsumption for 60 days. Subjects should consume two capsules in the morning and two capsules in the afternoon. |
| Control group | Placebo comparator | Other: Control product consumptionConsumption for 60 days. Subjects should consume two capsules in the morning and two capsules in the afternoon. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3 and/or botanical ingredientConsumption for 60 days. Subjects should consume two capsules in the morning and two capsules in the afternoon. | Dietary supplement | Botanical ingredient, Combination of Omega-3 based product and botanical ingredient, Omega-3 based product |
| Control product consumptionProduct 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. | Other | Control group |
Primary outcome
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.
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.
12 secondary outcomes
Change in Pain from baseline at 8 weeks
Time frame: Pain will be measured with a daily scale, from baseline to 8 weeks.
Functional test
Time frame: The test will be measured at baseline and after 8 weeks of consumption.
Muscle function
Time frame: The test will be measured at baseline and after 8 weeks of consumption.
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
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.
Sleep quality
Time frame: It will be measured twice, once at baseline or at the end of the study after 8 weeks of use
Omega-3 Bioavailability
Time frame: It will be measured twice, once at baseline or at the end of the study after 8 weeks.
Liver safety variables
Time frame: It will be measured twice, once at baseline or at the end of the study after 8 weeks.
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.
Physical activity control
Time frame: The test will be measured at baseline and after 8 weeks of consumption.
Body composition
Time frame: The test will be measured at baseline and after 8 weeks of consumption.
Waist - hip circumference
Time frame: The test will be measured at baseline and after 8 weeks of consumption.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fco Javier López Roman principal investigator
Catholic University of Murcia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 and/or botanical ingredient in people with Joint Function Disorder, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain from baseline at 8 weeks (time frame: The evolution of pain after consumption during 8 weeks will be measured.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2022.