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

NCT ID: NCT05287659

Last Updated: 2022-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-03
• Study Completion Date: 2022-03-04

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

VLCKD group

patients followed a structured VLCKD protocol (800Kcal/die)

Group Type: EXPERIMENTAL

meal replacements or supplementation with leucine

Intervention Type: DIETARY_SUPPLEMENT

meal replacements or animal protein or supplementation with leucine

VLCKD and Physical Training group

patients followed a structured VLCKD protocol (800Kcal/die) combined with interval training (IT), two times a week

Group Type: ACTIVE_COMPARATOR

meal replacements or supplementation with leucine

Intervention Type: DIETARY_SUPPLEMENT

meal replacements or animal protein or supplementation with leucine

LCD and Leucine supplementation group

patients followed a LCD regimen (1000 kcal/day) with supplementation of 18 g whey proteins which 4.1 g of leucine

Group Type: ACTIVE_COMPARATOR

meal replacements or supplementation with leucine

Intervention Type: DIETARY_SUPPLEMENT

meal replacements or animal protein or supplementation with leucine

Interventions

meal replacements or supplementation with leucine

meal replacements or animal protein or supplementation with leucine

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• obesity (BMI 30-40)
• FAT MASS % ( > 41% for W, >29% for M)
• HOMA-IR > 2,5

Exclusion Criteria

• known hypersensitivity to one or more components used in the protocol products; history of renal, cardiac or cerebrovascular diseases; psychiatric disturbances; hydroelectrolytic alterations, diagnosis of type 1 diabetes lack of informed consent; history of or planned weight loss surgery

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Roma La Sapienza

OTHER

Sponsor Role: lead

Responsible Party

Lucio Gnessi

Lucio Gnessi

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sapienza University of Rome

Roma, RM, Italy

Countries

Italy

Other Identifiers

DM2022SO

Identifier Type: -

Identifier Source: org_study_id