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

Primary Purpose

Sarcopenic Obesity

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

meal replacements or supplementation with leucine

About this trial

This is an interventional treatment trial for Sarcopenic Obesity

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Sapienza University of Rome

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

VLCKD group

VLCKD and Physical Training group

LCD and Leucine supplementation group

Arm Description

patients followed a structured VLCKD protocol (800Kcal/die)

patients followed a structured VLCKD protocol (800Kcal/die) combined with interval training (IT), two times a week

patients followed a LCD regimen (1000 kcal/day) with supplementation of 18 g whey proteins which 4.1 g of leucine

Outcomes

Primary Outcome Measures

Body weight

Body weight change from baseline

Secondary Outcome Measures

Body Mass Index

Body Mass Index change from baseline

Fat Mass

Fat mass percentage (%) change from baseline

Fat Free Mass

Fat Free mass percentage (%) change from baseline

Fasting glucose

Fasting glucose level (mg/dL) change from baseline

Fasting insulin

Fasting Insulin level (mcU/mL) change from baseline

Muscle strength

Muscle strength (kg) change from baseline

Physical Performance assessed by Short Physical Performance Battery (SPPB)

Physical Performance change from baseline

Full Information

NCT ID

NCT05287659

First Posted

March 4, 2022

Last Updated

March 16, 2022

Sponsor

University of Roma La Sapienza

1. Study Identification

Unique Protocol Identification Number

NCT05287659

Brief Title

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

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

January 3, 2022 (Actual)

Primary Completion Date

February 4, 2022 (Actual)

Study Completion Date

March 4, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Roma La Sapienza

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sarcopenic Obesity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

VLCKD group

Arm Type

Experimental

Arm Description

patients followed a structured VLCKD protocol (800Kcal/die)

Arm Title

VLCKD and Physical Training group

Arm Type

Active Comparator

Arm Description

patients followed a structured VLCKD protocol (800Kcal/die) combined with interval training (IT), two times a week

Arm Title

LCD and Leucine supplementation group

Arm Type

Active Comparator

Arm Description

patients followed a LCD regimen (1000 kcal/day) with supplementation of 18 g whey proteins which 4.1 g of leucine

Intervention Type

Dietary Supplement

Intervention Name(s)

meal replacements or supplementation with leucine

Intervention Description

meal replacements or animal protein or supplementation with leucine

Primary Outcome Measure Information:

Title

Body weight

Description

Body weight change from baseline

Time Frame

Body weight will be calculated at baseline and after 45 days

Secondary Outcome Measure Information:

Title

Body Mass Index

Description

Body Mass Index change from baseline

Time Frame

Body Mass Index will be calculated at baseline and after 45 days

Title

Fat Mass

Description

Fat mass percentage (%) change from baseline

Time Frame

Fat Mass will be calculated at baseline and after 45 days

Title

Fat Free Mass

Description

Fat Free mass percentage (%) change from baseline

Time Frame

Fat Free mass will be calculated at baseline and after 45 days

Title

Fasting glucose

Description

Fasting glucose level (mg/dL) change from baseline

Time Frame

Fasting glucose will be calculated at baseline and after 45 days

Title

Fasting insulin

Description

Fasting Insulin level (mcU/mL) change from baseline

Time Frame

Fasting insulin will be calculated at baseline and after 45 days

Title

Muscle strength

Description

Muscle strength (kg) change from baseline

Time Frame

Muscle strength will be calculated at baseline and after 45 days

Title

Physical Performance assessed by Short Physical Performance Battery (SPPB)

Description

Physical Performance change from baseline

Time Frame

SPPB will be calculated at baseline and after 45 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Sapienza University of Rome

City

Roma

State/Province

ZIP/Postal Code

00161

Country

Italy

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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