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

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

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.

Study Overview

• Status: Completed
• Conditions: Sarcopenic Obesity
• Intervention / Treatment: Dietary supplement: meal replacements or supplementation with leucine

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • RM
    • Roma, RM, Italy, 00161
      • Sapienza University of Rome

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VLCKD group; patients followed a structured VLCKD protocol (800Kcal/die)	Dietary supplement: meal replacements or supplementation with leucine; meal replacements or animal protein or supplementation with leucine
Active Comparator: VLCKD and Physical Training group; patients followed a structured VLCKD protocol (800Kcal/die) combined with interval training (IT), two times a week	Dietary supplement: meal replacements or supplementation with leucine; meal replacements or animal protein or supplementation with leucine
Active Comparator: LCD and Leucine supplementation group; patients followed a LCD regimen (1000 kcal/day) with supplementation of 18 g whey proteins which 4.1 g of leucine	Dietary supplement: meal replacements or supplementation with leucine; meal replacements or animal protein or supplementation with leucine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight	Body weight change from baseline	Body weight will be calculated at baseline and after 45 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Roma La Sapienza

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2022
• Primary Completion (Actual): February 4, 2022
• Study Completion (Actual): March 4, 2022

Study Registration Dates

• First Submitted: March 4, 2022
• First Submitted That Met QC Criteria: March 16, 2022
• First Posted (Actual): March 18, 2022

Study Record Updates

• Last Update Posted (Actual): March 18, 2022
• Last Update Submitted That Met QC Criteria: March 16, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Body Weight Changes; Obesity; Weight Loss
• Other Study ID Numbers: DM2022SO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No