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

NCT05287659 — Not applicable, Completed, 50 participants, University of Roma La Sapienza

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

Registry	NCT05287659
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	50 (Actual)
Sponsor	University of Roma La Sapienza (Other)
Conditions	Sarcopenic Obesity
Interventions	meal replacements or supplementation with leucine (Dietary supplement)
Dates	start 2022-01-03, primary completion 2022-02-04, completion 2022-03-04, first posted 2022-03-18, last updated 2022-03-18
Locations	1 site in Italy

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
VLCKD group	Experimental	Dietary Supplement: meal replacements or supplementation with leucine	patients followed a structured VLCKD protocol (800Kcal/die)
VLCKD and Physical Training group	Active comparator	Dietary Supplement: meal replacements or supplementation with leucine	patients followed a structured VLCKD protocol (800Kcal/die) combined with interval training (IT), two times a week
LCD and Leucine supplementation group	Active comparator	Dietary Supplement: meal replacements or supplementation with leucine	patients followed a LCD regimen (1000 kcal/day) with supplementation of 18 g whey proteins which 4.1 g of leucine

meal replacements or supplementation with leucine (Dietary supplement): meal replacements or animal protein or supplementation with leucine

+Outcome measures

Primary outcomes

Body weight [Body weight will be calculated at baseline and after 45 days]: Body weight change from baseline

Secondary outcomes

Body Mass Index [Body Mass Index will be calculated at baseline and after 45 days]: Body Mass Index change from baseline
Fat Mass [Fat Mass will be calculated at baseline and after 45 days]: Fat mass percentage (%) change from baseline
Fat Free Mass [Fat Free mass will be calculated at baseline and after 45 days]: Fat Free mass percentage (%) change from baseline
Fasting glucose [Fasting glucose will be calculated at baseline and after 45 days]: Fasting glucose level (mg/dL) change from baseline
Fasting insulin [Fasting insulin will be calculated at baseline and after 45 days]: Fasting Insulin level (mcU/mL) change from baseline
Muscle strength [Muscle strength will be calculated at baseline and after 45 days]: Muscle strength (kg) change from baseline
Physical Performance assessed by Short Physical Performance Battery (SPPB) [SPPB will be calculated at baseline and after 45 days]: Physical Performance change from baseline

+Eligibility

Sex: All, ages: 50 Years to 70 Years

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

+Locations (1)

Facility	City	Country	Status
Sapienza University of Rome	Roma, RM	Italy