Sarcopenic ObesityNCT05287659
Low Calorie Diet or VLCKD Combined With Physical Training for Preserving Muscle Mass During Weight Loss in Sarcopenic Obesity
A study testing meal replacements or supplementation with leucine in people with Sarcopenic Obesity, run by University of Roma La Sapienza at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Sarcopenic Obesity
- What is being tested?
- meal replacements or supplementation with leucine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 3 Jan 2022to 4 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- obesity (BMI 30-40)
- FAT MASS % ( > 41% for W, >29% for M)
- HOMA-IR > 2,5
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- meal replacements or supplementation with leucine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
meal replacements or supplementation with leucineDietary supplement
meal replacements or animal protein or supplementation with leucine
| Study group | Role | What they receive |
|---|---|---|
| VLCKD group | Experimental | patients followed a structured VLCKD protocol (800Kcal/die) Receives: 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 Receives: 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 Receives: Dietary Supplement: meal replacements or supplementation with leucine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Body weight change from baseline
Measured: Body weight will be calculated at baseline and after 45 days
Secondary outcomes (7)
Body Mass Index
Body Mass Index change from baseline
Measured: Body Mass Index will be calculated at baseline and after 45 days
Fat Mass
Fat mass percentage (%) change from baseline
Measured: Fat Mass will be calculated at baseline and after 45 days
Fat Free Mass
Fat Free mass percentage (%) change from baseline
Measured: Fat Free mass will be calculated at baseline and after 45 days
Fasting glucose
Fasting glucose level (mg/dL) change from baseline
Measured: Fasting glucose will be calculated at baseline and after 45 days
Fasting insulin
Fasting Insulin level (mcU/mL) change from baseline
Measured: Fasting insulin will be calculated at baseline and after 45 days
Muscle strength
Muscle strength (kg) change from baseline
Measured: 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
Measured: SPPB will be calculated at baseline and after 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start3 Jan 2022
- Primary completion4 Feb 2022
- Study completion4 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sarcopenic ObesityStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lucio Gnessi, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05287659
- Sponsor's protocol ID
- DM2022SO
- Status last verified
- Mar 2022
- First submitted
- 4 Mar 2022
- Last updated
- 18 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05287659
- Acronym / sponsor ID
- DM2022SO
- Conditions
- Sarcopenic Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 3 Jan 2022 (actual)
- Primary completion
- 4 Feb 2022 (actual)
- Study completion
- 4 Mar 2022 (actual)
- First posted
- 18 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VLCKD group | Experimental | Dietary Supplement: meal replacements or supplementation with leucinepatients followed a structured VLCKD protocol (800Kcal/die) |
| VLCKD and Physical Training group | Active comparator | Dietary Supplement: meal replacements or supplementation with leucinepatients followed a structured VLCKD protocol (800Kcal/die) combined with interval training (IT), two times a week |
| LCD and Leucine supplementation group | Active comparator | Dietary Supplement: meal replacements or supplementation with leucinepatients followed a LCD regimen (1000 kcal/day) with supplementation of 18 g whey proteins which 4.1 g of leucine |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- obesity (BMI 30-40)
- FAT MASS % ( > 41% for W, >29% for M)
- HOMA-IR > 2,5
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| meal replacements or supplementation with leucinemeal replacements or animal protein or supplementation with leucine | Dietary supplement | LCD and Leucine supplementation group, VLCKD and Physical Training group, VLCKD group |
Primary outcome
Body weight
Time frame: Body weight will be calculated at baseline and after 45 days
Body weight change from baseline
7 secondary outcomes
Body Mass Index
Time frame: Body Mass Index will be calculated at baseline and after 45 days
Fat Mass
Time frame: Fat Mass will be calculated at baseline and after 45 days
Fat Free Mass
Time frame: Fat Free mass will be calculated at baseline and after 45 days
Fasting glucose
Time frame: Fasting glucose will be calculated at baseline and after 45 days
Fasting insulin
Time frame: Fasting insulin will be calculated at baseline and after 45 days
Muscle strength
Time frame: Muscle strength will be calculated at baseline and after 45 days
Physical Performance assessed by Short Physical Performance Battery (SPPB)
Time frame: SPPB will be calculated at baseline and after 45 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing meal replacements or supplementation with leucine in people with Sarcopenic Obesity, run by University of Roma La Sapienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (time frame: Body weight will be calculated at baseline and after 45 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2022.