| Registry | NCT06757452, acronym curcuminoids |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional; randomized, parallel, masking: triple, other |
| Enrollment | 34 (Actual) |
| Sponsor | Lissette Ariza Corredor (Industry); collaborators: Universidad de Caldas |
| Conditions | Sedentariness and Well-being |
| Interventions | Supplement with curcuminoids, Physical excercise (Dietary supplement, other) |
| Dates | start 2023-07-05, primary completion 2023-11-08, completion 2023-11-08, first posted 2025-01-03, last updated 2025-01-08 |
| Locations | 1 site in Colombia |
Related Papers Related Patents Related Grants Related Experts
All trials for Sedentariness and Well-being All trials of Supplement with curcuminoids All trials of Physical excercise
-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.
Expand all sections · Collapse all
+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Placebo | Placebo comparator | Other: Physical excercise | Experimental 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 excercise | 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. |
- Supplement with curcuminoids (Dietary supplement), also known as 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 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.
+Outcome measures
Primary outcomes
- RMSSD [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
- Creatinine [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.
- CK [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.
- LDH [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.
- Urea [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.
- SOD [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.
+Eligibility
Sex: All, ages: 25 Years to any
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.
+Locations (1)
| Facility | City | Country | Status |
|---|
| Universidad de Caldas | Manizales, Caldas Department | Colombia | |