Sapienza University of Rome
Roma, RM, 00161, Italy
NCT Number: NCT05287659
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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Notify Me50 year–70 year
All sexes
Interventional
Not applicable
Roma, RM, 00161, Italy
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
meal replacements or animal protein or supplementation with leucine
Time frame: Body weight will be calculated at baseline and after 45 days
Body weight change from baseline
Time frame: Body Mass Index will be calculated at baseline and after 45 days
Body Mass Index change from baseline
Time frame: Fat Mass will be calculated at baseline and after 45 days
Fat mass percentage (%) change from baseline
Time frame: Fat Free mass will be calculated at baseline and after 45 days
Fat Free mass percentage (%) change from baseline
Time frame: Fasting glucose will be calculated at baseline and after 45 days
Fasting glucose level (mg/dL) change from baseline
Time frame: Fasting insulin will be calculated at baseline and after 45 days
Fasting Insulin level (mcU/mL) change from baseline
Time frame: Muscle strength will be calculated at baseline and after 45 days
Muscle strength (kg) change from baseline
Time frame: SPPB will be calculated at baseline and after 45 days
Physical Performance change from baseline
University of Roma La Sapienza
Other
Low Calorie Diet or Very Low Calorie Ketogenic Diet Combined With Physical Training for Preserving Muscle Mass During Weight Loss in Sarcopenic Obesity
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