The Effect of Supplementation with Curcuminoids for the Improvement of Musculoskeletal Conditions in Sedentary Adults (curcuminoids)

January 7, 2025 updated by: Lissette Ariza Corredor
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
    • Caldas
      • Manizales, Caldas, Colombia, 170004
        • Universidad de Caldas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • To have a history or diagnoses of cardiopulmonary, osteoarticular, type 1 diabetes or autoimmune disorders
  • Pregnancy
  • Smokers.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo

Experimental unit who received Placebo were treated equaly as the supplemented group.

The control group received a placebo capsule of 250 mg maltodextrin.
Other: Physical excercise
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.
Experimental: Supplemented
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.
Other: Physical excercise
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.
Dietary supplement: Supplement with curcuminoids
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.
Other Names:
  • Cal LX

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Twice a week, prior and after the physical activity, during the three monts of intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Creatinine
Time Frame: Every 30 days, begining the first day physical activity, during the three monts of intervention.
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.
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.
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.
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.
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.
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.
Urea and creatinine levels are used to evaluate kidney function.
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.
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.
Every 30 days, begining the first day physical activity, during the three monts of intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lissette Ariza Corredor

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Universidad de Caldas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 5, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 8, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 8, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 19, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 26, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CBCS-030

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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