search
Back to results

Carnitine Supplementation and Bone Mineral Density

Primary Purpose

Osteoporosis

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
L-carnitine
L-leucine
Sponsored by
Poznan University of Physical Education
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoporosis

Eligibility Criteria

60 Years - 75 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • postmenopausal
  • lack of restrictions to perform resistance exercises

Exclusion Criteria:

  • cardiovascular disease
  • liver disease
  • kidney disease
  • neuromuscular disease
  • gastrointestinal disorders (including stomach ulcers and erosions)
  • diabetes
  • other severe chronic diseases

Sites / Locations

  • Akademia Wychowania Fizycznego

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

carnitine + leucine

leucine

Arm Description

1000 mg L-carnitine with 3000 mg L-leucine per day for 24 weeks

4000 mg L-leucine per day for 24 weeks

Outcomes

Primary Outcome Measures

Bone Mineral Density measured by dual-energy X-ray absorptiometry (DXA)
Bone mineral density (BMD) of the femoral neck, lumbar vertebrae L1-L4, and total hip determined by Lunar Prodigy Advance DXA (GE, Healthcare, Madison, Wisconsin, USA).

Secondary Outcome Measures

Body Composition: Body Fat Mass, Fat Free Mass, and Skeletal Muscle Mass using a bioelectrical impedance analyzer (InBody720).
The InBody720 measures impedance of five segments of the body (each arm, each leg, trunk) at frequencies of 1, 5, 50, 250, 500, and 1000 kHz through the 8-polar tactile-electrode. Based on the impedance, body fat mass, fat free mass, and skeletal muscle mass are calculated.
The circulating markers modification
Determination of serum interleukin-6, tumor necrosis factor alpha, C-reactive protein, and plasma trimethylamine N-oxide.

Full Information

First Posted
November 3, 2021
Last Updated
August 15, 2022
Sponsor
Poznan University of Physical Education
Collaborators
Medical University of Gdansk
search

1. Study Identification

Unique Protocol Identification Number
NCT05120011
Brief Title
Carnitine Supplementation and Bone Mineral Density
Official Title
Effect of Carnitine Supplementation and Resistance Training on Bone Mineral Density
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
July 7, 2018 (Actual)
Study Completion Date
July 7, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Poznan University of Physical Education
Collaborators
Medical University of Gdansk

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The primary aim of the current research project is to explore whether carnitine supplementation and resistance training may prevent decrements in bone mineral density of aged women. A secondary aim of this project is to investigate the effect of supplementation on body composition and blood markers.
Detailed Description
The study includes postmenopausal women. The subjects participate in resistance training (twice a week) for each session consisted of 6 exercises: horizontal seated leg press, seated chest press, leg extension, shoulder press, lat pull-down seated row, seated cable row. During the 24-weeks training programme participants are supplemented by carnitine with leucine, or leucine alone (placebo).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
carnitine + leucine
Arm Type
Experimental
Arm Description
1000 mg L-carnitine with 3000 mg L-leucine per day for 24 weeks
Arm Title
leucine
Arm Type
Placebo Comparator
Arm Description
4000 mg L-leucine per day for 24 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
L-carnitine
Intervention Description
L-carnitine-L-tartrate
Intervention Type
Dietary Supplement
Intervention Name(s)
L-leucine
Intervention Description
L-leucine
Primary Outcome Measure Information:
Title
Bone Mineral Density measured by dual-energy X-ray absorptiometry (DXA)
Description
Bone mineral density (BMD) of the femoral neck, lumbar vertebrae L1-L4, and total hip determined by Lunar Prodigy Advance DXA (GE, Healthcare, Madison, Wisconsin, USA).
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Body Composition: Body Fat Mass, Fat Free Mass, and Skeletal Muscle Mass using a bioelectrical impedance analyzer (InBody720).
Description
The InBody720 measures impedance of five segments of the body (each arm, each leg, trunk) at frequencies of 1, 5, 50, 250, 500, and 1000 kHz through the 8-polar tactile-electrode. Based on the impedance, body fat mass, fat free mass, and skeletal muscle mass are calculated.
Time Frame
24 weeks
Title
The circulating markers modification
Description
Determination of serum interleukin-6, tumor necrosis factor alpha, C-reactive protein, and plasma trimethylamine N-oxide.
Time Frame
24 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: postmenopausal lack of restrictions to perform resistance exercises Exclusion Criteria: cardiovascular disease liver disease kidney disease neuromuscular disease gastrointestinal disorders (including stomach ulcers and erosions) diabetes other severe chronic diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Olek, PhD
Organizational Affiliation
Poznan University of Physical Education
Official's Role
Principal Investigator
Facility Information:
Facility Name
Akademia Wychowania Fizycznego
City
Poznan
ZIP/Postal Code
61-871
Country
Poland

12. IPD Sharing Statement

Learn more about this trial

Carnitine Supplementation and Bone Mineral Density

We'll reach out to this number within 24 hrs