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

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: Completed
• Conditions: Sedentariness and Well-being
• Intervention / Treatment: Other: Physical excercise; Dietary supplement: Supplement with curcuminoids

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	Twice a week, prior and after the physical activity, during the three monts of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	Every 30 days, begining the first day physical activity, during the three monts of intervention.

Collaborators and Investigators

• Sponsor: Lissette Ariza Corredor
• Collaborators: Universidad de Caldas

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2023
• Primary Completion (Actual): November 8, 2023
• Study Completion (Actual): November 8, 2023

Study Registration Dates

• First Submitted: December 19, 2024
• First Submitted That Met QC Criteria: December 26, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 7, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: recovery; inflammation; antioxidants; sedentarism; curcuminoid
• Other Study ID 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