Sedentariness and Well-beingPhase 3curcuminoidsNCT06757452
The Effect of Supplementation with Curcuminoids for the Improvement of Musculoskeletal Conditions in Sedentary Adults
A Phase 3 study testing Supplement with curcuminoids and Physical excercise in people with Sedentariness and Well-being, run by Lissette Ariza Corredor at 1 site in Colombia.
Trial summary
The aim of this study is to evaluate the effect of a supplementation with curcuminoids, called Cal LX, prior to physical exercise, on the improvement of musculoskeletal conditions in sedentary people, which would lead to more physical exercise regularly. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Sedentariness and Well-being
- What is being tested?
- Supplement with curcuminoids and Physical excercise
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteColombia
- Study dates
- 5 Jul 2023to 8 Nov 2023
- Phase
- Phase 3
- 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 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be over 25 years old
- To have not exercised systematically during the last 3 months, or do not do physical exercise daily for more than 25 minutes per day for a maximum of 3 days per week
- Sitting for at least 4 hours continuously
- Type 2 diabetes patients.
Who cannot join
- To have a history or diagnoses of cardiopulmonary, osteoarticular, type 1 diabetes or autoimmune disorders
- Pregnancy
- Smokers.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to evaluate the effect of a supplementation with curcuminoids, called Cal LX, prior to physical exercise, on the improvement of musculoskeletal conditions in sedentary people, which would lead to more physical exercise regularly.
- Conditions
- Sedentariness and Well-being
- Being tested
- Supplement with curcuminoids, Physical excercise
- Keywords
- curcuminoid, sedentarism, recovery, inflammation, antioxidants
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supplement with curcuminoidsDietary supplement
Also called Cal LX
Cal LX is a food-grade dietary supplement based on turmeric, it has been designed to improve physical resistance during exercise, accelerate post-exercise recovery, and reduce the feeling of muscle soreness. Cal LX was determined as not cytotoxic or genotoxic. The supplement or placebo dosage was one (1) 250 mg capsule 45 minutes before exercising.
Physical excerciseOther
Participants performed 45 minutes of physical activity twice a week. The intervention program included a five-minute warm-up, composed of two series of joint mobility and three series of eight seconds of lower limbs stretching. Then, a routine of intermittent training composed of four six-minute rounds was directed. Each routine included running for 10 seconds and a pause between them. The first round had a 20 s pause, the second round 15 s, and the third and fourth rounds 10 s. Between the rounds was a two-minute passive pause. Finally, three series of twenty seconds of elongation of the lower extremities were required as colling down.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Experimental unit who received Placebo were treated equaly as the supplemented group.
The control group received a placebo capsule of 250 mg maltodextrin. Receives: Other: Physical excercise |
| Supplemented | Experimental | who received Cal LX. Cal LX is a food-grade dietary supplement based on turmeric, it has been designed to improve physical resistance during exercise, accelerate post-exercise recovery, and reduce the feeling of muscle soreness. Cal LX was determined as not cytotoxic or genotoxic. The supplement or placebo dosage was one (1) 250 mg capsule 45 minutes before exercising. Receives: Dietary Supplement: Supplement with curcuminoids; Other: Physical excercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
RMSSD
An indicator of parasympathetic activity by evaluating the root mean square of successive differences between normal heartbeats (RMSSD) determined in milliseconds, which is directly associated with short-term heart rate variability.
Measured: Twice a week, prior and after the physical activity, during the three monts of intervention
Secondary outcomes (5)
Creatinine
Creatinine is a waste product that comes from the digestion of protein in your food and the normal breakdown of muscle tissue. It is removed from the blood through your kidneys.
Measured: Every 30 days, begining the first day physical activity, during the three monts of intervention.
CK
Creatine kinase is an enzyme that's responsible for healthy muscle function. When muscles break down, they release CK, elevating the protein levels in your blood.
Measured: Every 30 days, begining the first day physical activity, during the three monts of intervention.
LDH
LDH is an enzyme found in many body tissues such as the heart, liver, kidney, skeletal muscle, brain, blood cells, and lungs. When body tissue is damaged, LDH is released into the blood.
Measured: Every 30 days, begining the first day physical activity, during the three monts of intervention.
Urea
Urea and creatinine levels are used to evaluate kidney function.
Measured: Every 30 days, begining the first day physical activity, during the three monts of intervention.
SOD
Superoxide dismutase (SOD) is an enzyme found in all living cells. An enzyme is a substance that speeds up certain chemical reactions in the body. Superoxide dismutase helps break down potentially harmful oxygen molecules in cells.
Measured: Every 30 days, begining the first day physical activity, during the three monts of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start5 Jul 2023
- Primary completion8 Nov 2023
- Study completion8 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentariness and Well-beingStudies 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 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lissette Ariza Corredor
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Universidad de Caldas
- Responsible party
- Sponsor-investigator, Lissette Ariza Corredor, Inbiotech
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06757452
- Sponsor's protocol ID
- CBCS-030
- Acronym
- curcuminoids
- Status last verified
- Dec 2024
- First submitted
- 19 Dec 2024
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Supplementation with Curcuminoids for the Improvement of Musculoskeletal Conditions in Sedentary Adults
- ClinicalTrials.gov ID
- NCT06757452
- Acronym / sponsor ID
- curcuminoids / CBCS-030
- Conditions
- Sedentariness and Well-being
- Keywords
- curcuminoid, sedentarism, recovery, inflammation, antioxidants
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Lissette Ariza CorredorIndustry (pharma, biotech, devices)
- Collaborators
- Universidad de Caldas
- Study start
- 5 Jul 2023 (actual)
- Primary completion
- 8 Nov 2023 (actual)
- Study completion
- 8 Nov 2023 (actual)
- First posted
- 3 Jan 2025 (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.
The aim of this study is to evaluate the effect of a supplementation with curcuminoids, called Cal LX, prior to physical exercise, on the improvement of musculoskeletal conditions in sedentary people, which would lead to more physical exercise regularly.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Physical excerciseExperimental unit who received Placebo were treated equaly as the supplemented group. The control group received a placebo capsule of 250 mg maltodextrin. |
| Supplemented | Experimental | Dietary Supplement: Supplement with curcuminoids, Other: Physical excercisewho received Cal LX. Cal LX is a food-grade dietary supplement based on turmeric, it has been designed to improve physical resistance during exercise, accelerate post-exercise recovery, and reduce the feeling of muscle soreness. Cal LX was determined as not cytotoxic or genotoxic. The supplement or placebo dosage was one (1) 250 mg capsule 45 minutes before exercising. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- To be over 25 years old
- To have not exercised systematically during the last 3 months, or do not do physical exercise daily for more than 25 minutes per day for a maximum of 3 days per week
- Sitting for at least 4 hours continuously
- Type 2 diabetes patients.
Key exclusion criteria (3 listed)
- To have a history or diagnoses of cardiopulmonary, osteoarticular, type 1 diabetes or autoimmune disorders
- Pregnancy
- Smokers.
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 |
|---|---|---|
| Supplement with curcuminoidsAlso: Cal LXCal LX is a food-grade dietary supplement based on turmeric, it has been designed to improve physical resistance during exercise, accelerate post-exercise recovery, and reduce the feeling of muscle soreness. Cal LX was determined as not cytotoxic or genotoxic. The supplement or placebo dosage was one (1) 250 mg capsule 45 minutes before exercising. | Dietary supplement | Supplemented |
| Physical excerciseParticipants performed 45 minutes of physical activity twice a week. The intervention program included a five-minute warm-up, composed of two series of joint mobility and three series of eight seconds of lower limbs stretching. Then, a routine of intermittent training composed of four six-minute rounds was directed. Each routine included running for 10 seconds and a pause between them. The first round had a 20 s pause, the second round 15 s, and the third and fourth rounds 10 s. Between the rounds was a two-minute passive pause. Finally, three series of twenty seconds of elongation of the lower extremities were required as colling down. | Other | Placebo, Supplemented |
Primary outcome
RMSSD
Time frame: Twice a week, prior and after the physical activity, during the three monts of intervention
An indicator of parasympathetic activity by evaluating the root mean square of successive differences between normal heartbeats (RMSSD) determined in milliseconds, which is directly associated with short-term heart rate variability.
5 secondary outcomes
Creatinine
Time frame: Every 30 days, begining the first day physical activity, during the three monts of intervention.
CK
Time frame: Every 30 days, begining the first day physical activity, during the three monts of intervention.
LDH
Time frame: Every 30 days, begining the first day physical activity, during the three monts of intervention.
Urea
Time frame: Every 30 days, begining the first day physical activity, during the three monts of intervention.
SOD
Time frame: Every 30 days, begining the first day physical activity, during the three monts of intervention.
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 8 Jan 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Supplement with curcuminoids and Physical excercise in people with Sedentariness and Well-being, run by Lissette Ariza Corredor at 1 site in Colombia.
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 4 inclusion and 3 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 8 Jan 2025. 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 Colombia. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
RMSSD (time frame: Twice a week, prior and after the physical activity, during the three monts of intervention). 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 8 Jan 2025.