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OpenTrials
Completed

NCT Number: NCT06757452

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

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.

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Key information

Age range

25 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Universidad de Caldas

Manizales, Caldas Department, 170004, Colombia

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Supplement with curcuminoids

Dietary Supplement

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

Physical excercise

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Lissette Ariza Corredor

Industry

Collaborators

  • Universidad de Caldas

Registry information

Acronym: curcuminoids

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 3, 2025
Registry last updated
Jan 8, 2025

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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