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Low Calorie Diet or VLCKD Combined With Physical Training for Preserving Muscle Mass During Weight Loss in Sarcopenic Obesity

NCT05287659 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-03-18

No results posted yet for this study

Summary

The prevalence of sarcopenic obesity (SO) is increasing worldwide, posing important challenges to public health and national health care system, especially during the COVID pandemic. In subjects with SO, it is essential to reduce body weight preserving lean mass, in order to avoid a worsening of muscle function. Lifestyle modification with adequate nutrition and proper physical activity is essential to counteract SO progression. In accordance with the Position Statement of the Italian Society of Endocrinology, Very Low Calorie Ketogenic Diet (VLCKD), a well established nutritional intervention in the context of obesity, has been promoted also for the treatment of SO. Moreover, the source of protein, timing of intake, and specific amino-acid constitution also represent critical factors in increasing muscle mass and strength. Recent studies have shown how protein supplementation, especially with high leucine content, can be effective in degenerative and end-stage diseases.

To date, the effects of physical training during VLCKD have not been studied. The aim is to determine the efficacy of VLCKD combined with interval training, compared to a VLCKD or a LCD alone, on weight-loss, body composition and physical performance in patient with SO.

Conditions

  • Sarcopenic Obesity

Interventions

DIETARY_SUPPLEMENT

meal replacements or supplementation with leucine

meal replacements or animal protein or supplementation with leucine

Sponsors & Collaborators

  • University of Roma La Sapienza

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-03
Primary Completion
2022-02-04
Completion
2022-03-04

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05287659 on ClinicalTrials.gov