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

NCT05287659 | Completed

• 1 other identifier: DM2022SO
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenic Obesity

Outcome Measures

Primary Outcomes (1)

• Body weight

  Body weight change from baseline

  Body weight will be calculated at baseline and after 45 days

Secondary Outcomes (7)

• Body Mass Index

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

• Fat Mass

  Fat Mass will be calculated at baseline and after 45 days

• Fat Free Mass

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

• Fasting glucose

  Fasting glucose will be calculated at baseline and after 45 days

• Fasting insulin

  Fasting insulin will be calculated at baseline and after 45 days

Study Arms (3)

VLCKD group

EXPERIMENTAL

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

Dietary Supplement: meal replacements or supplementation with leucine

VLCKD and Physical Training group

ACTIVE COMPARATOR

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

LCD and Leucine supplementation group

ACTIVE COMPARATOR

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

Interventions

meal replacements or supplementation with leucine DIETARY_SUPPLEMENT

meal replacements or animal protein or supplementation with leucine

LCD and Leucine supplementation group; VLCKD and Physical Training group; VLCKD group

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• obesity (BMI 30-40)
• FAT MASS % ( \> 41% for W, \>29% for M)
• HOMA-IR \> 2,5

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Sapienza University of Rome

Roma, RM, 00161, Italy

Location

MeSH Terms

Interventions

Dietary Supplements; Leucine

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lucio Gnessi

Study Record Dates

• First Submitted: March 4, 2022
• First Posted: March 18, 2022
• Study Start: January 3, 2022
• Primary Completion: February 4, 2022
• Study Completion: March 4, 2022
• Last Updated: March 18, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)