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OpenTrials
Completed

NCT Number: NCT05287659

Low Calorie Diet or VLCKD 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.

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Key information

Conditions

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sapienza University of Rome

Roma, RM, 00161, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

meal replacements or supplementation with leucine

Dietary Supplement

meal replacements or animal protein or supplementation with leucine

Primary outcomes

  1. Body weight

    Time frame: Body weight will be calculated at baseline and after 45 days

    Body weight change from baseline

Secondary outcomes

  1. Body Mass Index

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

    Body Mass Index change from baseline

  2. Fat Mass

    Time frame: Fat Mass will be calculated at baseline and after 45 days

    Fat mass percentage (%) change from baseline

  3. Fat Free Mass

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

    Fat Free mass percentage (%) change from baseline

  4. Fasting glucose

    Time frame: Fasting glucose will be calculated at baseline and after 45 days

    Fasting glucose level (mg/dL) change from baseline

  5. Fasting insulin

    Time frame: Fasting insulin will be calculated at baseline and after 45 days

    Fasting Insulin level (mcU/mL) change from baseline

  6. Muscle strength

    Time frame: Muscle strength will be calculated at baseline and after 45 days

    Muscle strength (kg) change from baseline

  7. Physical Performance assessed by Short Physical Performance Battery (SPPB)

    Time frame: SPPB will be calculated at baseline and after 45 days

    Physical Performance change from baseline

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 18, 2022
Registry last updated
Mar 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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