NCT06757452

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2023

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 5, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 8, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 8, 2023

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 3, 2025

Completed
Last Updated

January 8, 2025

Status Verified

December 1, 2024

Enrollment Period

4 months

First QC Date

December 19, 2024

Last Update Submit

January 7, 2025

Conditions

Sedentariness and Well-being

Keywords

curcuminoidsedentarismrecoveryinflammationantioxidants

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Creatinine

    Every 30 days, begining the first day physical activity, during the three monts of intervention.

  • CK

    Every 30 days, begining the first day physical activity, during the three monts of intervention.

  • LDH

    Every 30 days, begining the first day physical activity, during the three monts of intervention.

  • Urea

    Every 30 days, begining the first day physical activity, during the three monts of intervention.

  • SOD

    Every 30 days, begining the first day physical activity, during the three monts of intervention.

Study Arms (2)

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.

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.

Dietary Supplement: Supplement with curcuminoidsOther: Physical excercise

Interventions

Supplement with curcuminoidsDIETARY_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.

Also known as: Cal LX
Supplemented
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.

PlaceboSupplemented

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de Caldas

Manizales, Caldas Department, 170004, Colombia

Location

MeSH Terms

Conditions

Inflammation

Interventions

Diarylheptanoids

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HeptanesAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsHydrocarbons, AromaticHydrocarbons, Cyclic

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR INVESTIGATOR
PI Title
R&D Manager

Study Record Dates

First Submitted

December 19, 2024

First Posted

January 3, 2025

Study Start

July 5, 2023

Primary Completion

November 8, 2023

Study Completion

November 8, 2023

Last Updated

January 8, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

CO(1)