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

University of Roma La Sapienza

Status: Completed

Conditions: Sarcopenic Obesity

Treatments: Dietary Supplement: meal replacements or supplementation with leucine

Study type: Interventional

Funder types: Other

Identifiers

NCT05287659

DM2022SO

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 50 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 3 patient groups

VLCKD group

Experimental group

Description:

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

Treatment:

Dietary Supplement: meal replacements or supplementation with leucine

VLCKD and Physical Training group

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: meal replacements or supplementation with leucine

LCD and Leucine supplementation group

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: meal replacements or supplementation with leucine