Sarcopenic ObesityTATANCT03974893
Dietary Intake, Sarcopenic Obesity, and Other Treatment-Related Outcomes in Indian Children With Acute Lymphoblastic Leukemia
An observational study of Sarcopenic Obesity, run by Columbia University at 1 site in India.
Trial summary
Sarcopenic obesity occurs when there is a loss of muscle and gain of fat in the body. With this study, the investigators will explore how nutritional status at the beginning of the treatment can cause changes in your child's body fat compared to muscle in the body. Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Sarcopenic Obesity
- What is being tested?
- Vegetarian Diet
- How many people
- 115 participants
- Where
- 1 siteIndia
- Study dates
- 18 Apr 2019to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: 100 eligible children aged 5 - 15 years old will be recruited at Tata Memorial Hospital in Mumbai, India. Any children with deteriorating health or not being able to perform diet and exercise routines are ineligible. Children getting therapy outside Tata are not eligible.
Who may be able to join
- Newly diagnosed with ALL
- Able to consume ≥ 80% of dietary requirements enterally
- Adequate performance status (Lansky score ≥70)
- Receiving standard treatment for ALL on or as per the Indian Childhood Collaborative Leukemia Group's protocol (ICiCLe).
Who cannot join
- Refusal of consent
- Relapsed ALL
- Down's syndrome; (Other congenital anomalies too)
- Therapy initiated elsewhere
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dietary Intake, Sarcopenic Obesity, and Other Treatment-Related Outcomes in Indian Children With Acute Lymphoblastic Leukemia: A Pilot Study
Sarcopenic obesity occurs when there is a loss of muscle and gain of fat in the body. With this study, the investigators will explore how nutritional status at the beginning of the treatment can cause changes in your child's body fat compared to muscle in the body. The investigators will also look at how these changes can impact a child's cancer treatment, survival from treatment, and if there is any deterioration in health and nutrition status. The primary objective of this study is to establish the incidence of sarcopenic obesity, measured by dual-energy x-ray absorptiometry (DEXA), among Indian children and adolescents with acute lymphoblastic leukemia (ALL).
Read the detailed description
Survival of childhood ALL exceeds 80% in an increasing number of many low-middle income countries (LMIC). Recent studies have found that the effects of obesity on survival are observed within the first several years of diagnosis, thus impacting immediate health outcome. Of concern is the developing body of evidence that the effects of obesity may be underestimated and its effect on outcome may be even more pronounced when it is defined by body composition. An elevated body mass index (BMI) can be comprised of increased fat-free mass (FFM) or fat-mass (FM) or a combination of both. Evidence suggests that an increase of FM is a stronger predictor of risk of chronic disease rather than BMI. The evaluation of FM and FFM appears to have clinical implications in both adult and pediatric oncology, particularly in patients with Sarcopenic Obesity (SO) (increased FM and reduced FFM). Among children with ALL located in both high income countries (HIC) and LMIC, remediation of poor nutritional status during treatment removes its adverse effect on survival at the end of treatment. targeting dietary patterns may be a more effective approach when considering dietary interventions. One plausible way to examine the association of dietary patterns with the development of SO in pediatric ALL is to compare a vegetarian diet to a non-vegetarian diet and investigate how they are associated with its development. Children and adolescents with ALL at Tata Memorial Center (TMC) are well suited for this investigation because at least 30% of children follow a vegetarian diet, are easily identified, and the diets are not interchangeable. The benefit of the proposed model eliminates the need for dietary intervention prior to the study, which will examine how SO, accumulation of FM and the loss of FFM, develops among children and adolescents with ALL adhering to a vegetarian compared to non-vegetarian diet. Additionally, this study will examine the interaction of physical activity and diet while considering influential variables on the development of SO.
- Conditions
- Sarcopenic Obesity
- Being tested
- Vegetarian Diet
- Keywords
- Dietary intake, Diet, Acute lymphoblastic leukemia
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vegetarian DietOther
Dietary information will be collected utilizing a food record at four time points in therapy reflecting different intensities/drug exposures of treatment.
| Study group | Role | What they receive |
|---|---|---|
| Vegetarian Diet | Includes children following a vegetarian diet. Receives: Other: Vegetarian Diet | |
| Non-Vegetarian Diet | Includes children following a non-vegetarian diet. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Sarcopenic Obesity
Incidence of sarcopenic obesity, measured by dual-energy x-ray absorptiometry (DEXA), among Indian children and adolescents with ALL.
Measured: 6 months
Secondary outcomes (1)
Association of a Vegetarian Diet and Sarcopenic Obesity
Association of a vegetarian compared to a non-vegetarian diet and sarcopenic obesity, measured by dual-energy x-ray absorptiometry (DEXA)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start18 Apr 2019
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
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 Columbia UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Tata Memorial Hospital
- Responsible party
- Sponsor
- Investigators
- Elena J. Ladas, PhD, RD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03974893
- Sponsor's protocol ID
- AAAR8814
- Acronym
- TATA
- Status last verified
- Nov 2026
- First submitted
- 3 Jun 2019
- Last updated
- 3 Nov 2026
- 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 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Intake, Sarcopenic Obesity, and Other Treatment-Related Outcomes in Indian Children With Acute Lymphoblastic Leukemia: A Pilot Study
- ClinicalTrials.gov ID
- NCT03974893
- Acronym / sponsor ID
- TATA / AAAR8814
- Conditions
- Sarcopenic Obesity
- Keywords
- Dietary intake, Diet, Acute lymphoblastic leukemia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Tata Memorial Hospital
- Study start
- 18 Apr 2019 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 5 Jun 2019 (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.
Sarcopenic obesity occurs when there is a loss of muscle and gain of fat in the body. With this study, the investigators will explore how nutritional status at the beginning of the treatment can cause changes in your child's body fat compared to muscle in the body. The investigators will also look at how these changes can impact a child's cancer treatment, survival from treatment, and if there is any deterioration in health and nutrition status. The primary objective of this study is to establish the incidence of sarcopenic obesity, measured by dual-energy x-ray absorptiometry (DEXA), among Indian children and adolescents with acute lymphoblastic leukemia (ALL).
Detailed description
Survival of childhood ALL exceeds 80% in an increasing number of many low-middle income countries (LMIC). Recent studies have found that the effects of obesity on survival are observed within the first several years of diagnosis, thus impacting immediate health outcome. Of concern is the developing body of evidence that the effects of obesity may be underestimated and its effect on outcome may be even more pronounced when it is defined by body composition. An elevated body mass index (BMI) can be comprised of increased fat-free mass (FFM) or fat-mass (FM) or a combination of both. Evidence suggests that an increase of FM is a stronger predictor of risk of chronic disease rather than BMI. The evaluation of FM and FFM appears to have clinical implications in both adult and pediatric oncology, particularly in patients with Sarcopenic Obesity (SO) (increased FM and reduced FFM). Among children with ALL located in both high income countries (HIC) and LMIC, remediation of poor nutritional status during treatment removes its adverse effect on survival at the end of treatment. targeting dietary patterns may be a more effective approach when considering dietary interventions. One plausible way to examine the association of dietary patterns with the development of SO in pediatric ALL is to compare a vegetarian diet to a non-vegetarian diet and investigate how they are associated with its development. Children and adolescents with ALL at Tata Memorial Center (TMC) are well suited for this investigation because at least 30% of children follow a vegetarian diet, are easily identified, and the diets are not interchangeable. The benefit of the proposed model eliminates the need for dietary intervention prior to the study, which will examine how SO, accumulation of FM and the loss of FFM, develops among children and adolescents with ALL adhering to a vegetarian compared to non-vegetarian diet. Additionally, this study will examine the interaction of physical activity and diet while considering influential variables on the development of SO.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vegetarian Diet | – | Other: Vegetarian DietIncludes children following a vegetarian diet. |
| Non-Vegetarian Diet | – | –Includes children following a non-vegetarian diet. |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 100 eligible children aged 5 - 15 years old will be recruited at Tata Memorial Hospital in Mumbai, India. Any children with deteriorating health or not being able to perform diet and exercise routines are ineligible. Children getting therapy outside Tata are not eligible.
Key inclusion criteria (4 listed)
- Newly diagnosed with ALL
- Able to consume ≥ 80% of dietary requirements enterally
- Adequate performance status (Lansky score ≥70)
- Receiving standard treatment for ALL on or as per the Indian Childhood Collaborative Leukemia Group's protocol (ICiCLe).
Key exclusion criteria (4 listed)
- Refusal of consent
- Relapsed ALL
- Down's syndrome; (Other congenital anomalies too)
- Therapy initiated elsewhere
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 |
|---|---|---|
| Vegetarian DietDietary information will be collected utilizing a food record at four time points in therapy reflecting different intensities/drug exposures of treatment. | Other | Vegetarian Diet |
Primary outcome
Incidence of Sarcopenic Obesity
Time frame: 6 months
Incidence of sarcopenic obesity, measured by dual-energy x-ray absorptiometry (DEXA), among Indian children and adolescents with ALL.
1 secondary outcome
Association of a Vegetarian Diet and Sarcopenic Obesity
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- 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.
Elena J. Ladas, PhD, RD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenic Obesity, run by Columbia University at 1 site in India.
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 4 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. 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 India. 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?
This study is still under way. Results are not available in the source record yet.
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?
Incidence of Sarcopenic Obesity (time frame: 6 months). 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 3 Nov 2026.