Clinical trial NCT05287659: Low Calorie Diet or VLCKD Combined With Physical Training for Preserving Muscle Mass During Weight Loss in Sarcopenic Obesity
Official title: Low Calorie Diet or Very Low Calorie Ketogenic Diet Combined With Physical Training for Preserving Muscle Mass During Weight Loss in Sarcopenic Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenic Obesity
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2022-03-18
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Body weight
timeFrame: Body weight will be calculated at baseline and after 45 days
Secondary outcomes:
measure: Body Mass Index
timeFrame: Body Mass Index will be calculated at baseline and after 45 days
measure: Fat Mass
timeFrame: Fat Mass will be calculated at baseline and after 45 days
measure: Fat Free Mass
timeFrame: Fat Free mass will be calculated at baseline and after 45 days
measure: Fasting glucose
timeFrame: Fasting glucose will be calculated at baseline and after 45 days
measure: Fasting insulin
timeFrame: Fasting insulin will be calculated at baseline and after 45 days
measure: Muscle strength
timeFrame: Muscle strength will be calculated at baseline and after 45 days
measure: Physical Performance assessed by Short Physical Performance Battery (SPPB)
timeFrame: SPPB will be calculated at baseline and after 45 days
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Sapienza University of Rome
state: RM
Study officials:
References: