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

Sarcopenic Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05287659
• Other study ID #: DM2022SO
• Status: Completed
• Phase: N/A
• Start date: January 3, 2022
• Est. completion date: March 4, 2022

Study information

• Verified date: March 2022
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 4, 2022
• Est. primary completion date: February 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Sarcopenic Obesity
• Weight Loss

Intervention

Dietary Supplement:
• meal replacements or supplementation with leucine
meal replacements or animal protein or supplementation with leucine

Locations

Country	Name	City	State
Italy	Sapienza University of Rome	Roma	RM

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight	Body weight change from baseline	Body weight will be calculated at baseline and after 45 days
Secondary	Body Mass Index	Body Mass Index change from baseline	Body Mass Index will be calculated at baseline and after 45 days
Secondary	Fat Mass	Fat mass percentage (%) change from baseline	Fat Mass will be calculated at baseline and after 45 days
Secondary	Fat Free Mass	Fat Free mass percentage (%) change from baseline	Fat Free mass will be calculated at baseline and after 45 days
Secondary	Fasting glucose	Fasting glucose level (mg/dL) change from baseline	Fasting glucose will be calculated at baseline and after 45 days
Secondary	Fasting insulin	Fasting Insulin level (mcU/mL) change from baseline	Fasting insulin will be calculated at baseline and after 45 days
Secondary	Muscle strength	Muscle strength (kg) change from baseline	Muscle strength will be calculated at baseline and after 45 days
Secondary	Physical Performance assessed by Short Physical Performance Battery (SPPB)	Physical Performance change from baseline	SPPB will be calculated at baseline and after 45 days