Carnitine Supplementation and Bone Mineral Density

NCT ID: NCT05120011

Last Updated: 2022-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2018-07-07

Brief Summary

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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

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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).

Conditions

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Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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carnitine + leucine

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

Group Type EXPERIMENTAL

L-carnitine

Intervention Type DIETARY_SUPPLEMENT

L-carnitine-L-tartrate

L-leucine

Intervention Type DIETARY_SUPPLEMENT

L-leucine

leucine

4000 mg L-leucine per day for 24 weeks

Group Type PLACEBO_COMPARATOR

L-leucine

Intervention Type DIETARY_SUPPLEMENT

L-leucine

Interventions

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L-carnitine

L-carnitine-L-tartrate

Intervention Type DIETARY_SUPPLEMENT

L-leucine

L-leucine

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of Gdansk

OTHER

Sponsor Role collaborator

Poznan University of Physical Education

OTHER

Sponsor Role lead

Responsible Party

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Robert Olek

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert Olek, PhD

Role: PRINCIPAL_INVESTIGATOR

Poznan University of Physical Education

Locations

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Akademia Wychowania Fizycznego

Poznan, , Poland

Site Status

Countries

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Poland

References

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Olek RA, Samborowska E, Wisniewski P, Wojtkiewicz P, Wochna K, Zielinski J. Effect of a 3-month L-carnitine supplementation and resistance training program on circulating markers and bone mineral density in postmenopausal women: a randomized controlled trial. Nutr Metab (Lond). 2023 Aug 2;20(1):32. doi: 10.1186/s12986-023-00752-1.

Reference Type DERIVED
PMID: 37533033 (View on PubMed)

Other Identifiers

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BW2021/RO

Identifier Type: -

Identifier Source: org_study_id

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