ObesityNCT05464186
Effects of Whole vs. Nonfat Milk Consumption on Body Composition in Children
A study testing Whole milk and Nonfat milk in people with Obesity and Diabetes, run by Boston Children's Hospital at 1 site in United States.
Trial summary
This study will evaluate the effects of whole vs. nonfat milk consumption on body composition, cardiometabolic disease risk factors, and dietary quality. Read more about this study
- Who is it for?
- Ages 9 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Diabetes, Cardiovascular Diseases
- What is being tested?
- Whole milk and Nonfat milk
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Dec 2022to Dec 2026
- Phase
- Interventional
- 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 9 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged 9 to 12 years
- BMI ≥75th percentile for sex and age
- Residence in the Greater Boston catchment area
Who cannot join
- Aversion to nonfat or whole milk
- Physician diagnosis of major medical illness, eating disorder, or milk allergy (lactose intolerance not exclusionary as lactase treated milk can be provided)
- Plans to move away from the Greater Boston catchment area during the study period
- Plans to be away from home for ≥5 weeks during the study period (e.g., extended summer vacation)
- Change in body weight exceeding 10% during prior year
- Recent adherence to a special diet
- Chronic use of any medication or dietary supplement that could affect study outcomes
- Another member of the family (first degree relative) or household participating in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
New Balance Foundation Obesity Prevention Center
Boston, Massachusetts, 02115
Donna L Lesperance, MA, MPH, 617-919-7305, Donna.Lesperance@childrens.harvard.edu
About this study
Official title: Effects of Whole vs. Nonfat Milk Consumption on Body Composition in Children: a 1-Year RCT
This study will evaluate the effects of whole vs. nonfat milk consumption on body composition, cardiometabolic disease risk factors, and dietary quality.
Read the detailed description
Background The optimal type of milk is a topic of much debate. Several recent observational studies indicate that consuming whole (full-fat), compared to reduced-fat milk, is associated with less weight gain and decreased cardiometabolic disease risk. The observed beneficial effect of consuming whole milk on body weight may be due to its greater satiety value, leading to consumption of fewer calories from other lower quality (e.g., sugary) foods. Mechanistic studies indicate that substitution of carbohydrate with certain saturated fatty acids in milk increases low-density lipoprotein cholesterol (LDL-C). However, this increase has been attributed to large, buoyant particles that are less atherogenic than small, dense particles; is accompanied by an increase in high-density lipoprotein cholesterol (HDL-C); and may not elevate overall risk compared to carbohydrate.
Specific Aims and Hypotheses
- To examine the effects of milk consumption on body composition (Aim #1) and cardiometabolic disease risk factors (Aim #2). Primary Hypothesis. Consuming whole milk will result in less weight gain compared to consuming nonfat milk. Secondary hypothesis. Consuming whole milk will decrease cardiometabolic disease risk compared to consuming nonfat milk.
- To explore the effects of milk consumption on dietary quality (Aim #3). Exploratory hypothesis. Consuming whole milk will improve overall dietary quality by displacing lower quality foods compared to consuming nonfat milk, particularly among children with low baseline dietary quality.
- (Ancillary Study) To evaluate the effects of milk consumption on risk and prevalence of dental caries.
Design Randomized Controlled Trial. Participants (N=200, aged 9 to 12 years, BMI≥75th percentile) will be randomly assigned for 1 year to receive: 1) Whole milk, 3 cups/d or 2) Nonfat milk, 3 cups/d. To promote adherence to the interventions, the investigators will rely on home delivery of milk using methods consistent with previous successful studies.
Study Outcomes The primary outcome is change in fat mass measured by air displacement plethysmography (BodPod) at 3 time points (baseline and 6 and 12 months). To evaluate cardiometabolic disease risk factors, the investigators will obtain a plasma MetaboProfile®(LabCorp) that includes lipoprotein particle sizes and subfraction concentrations, novel measures of insulin-resistant dyslipoproteinemia and inflammation, and a conventional lipid profile. The investigators will also measure blood pressure.
For the Ancillary Study, outcomes include salivary cariogenicity (pH, flow, and buffering capacity); caries prevalence; dietary quality (cariogenic potential); and serum 25-hydroxyvitamin D.
- Conditions
- Obesity, Diabetes, Cardiovascular Diseases
- Being tested
- Whole milk, Nonfat milk
- Medical subject headings
- Obesity, Diabetes Mellitus, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole milkBehavioural
Weekly home delivery of whole milk, daily text messages, monthly virtual visits
Nonfat milkBehavioural
Weekly home delivery of nonfat milk, daily text messages, monthly virtual visits
| Study group | Role | What they receive |
|---|---|---|
| Whole milk | Experimental | 3 cups a day of whole milk for 1 year Receives: Behavioral: Whole milk |
| Nonfat milk | Experimental | 3 cups a day of nonfat milk for 1 year Receives: Behavioral: Nonfat milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat mass
Primary outcome for the overall study, main outcome for Specific Aim #1, measured by air displacement plethysmography (BodPod)
Measured: Change from start of trial (time of randomization) through end of trial (12 months)
Secondary outcomes (33)
Lean body mass
Measured by air displacement plethysmography (BodPod)
Measured: Change from start of trial (time of randomization) through end of trial (12 months)
Percent body fat
Measured by air displacement plethysmography (BodPod)
Measured: Change from start of trial (time of randomization) through end of trial (12 months)
Height
Linear growth
Measured: Change from start of trial (time of randomization) through end of trial (12 months)
Body mass index (BMI)
Weight in kg divided by height in meters squared
Measured: Change from start of trial (time of randomization) through end of trial (12 months)
Leptin
"Satiety" hormone, released by fat cells, measured by ELISA assay
Measured: Change from start of trial (time of randomization) through end of trial (12 months)
Ghrelin
"Hunger" hormone, released primarily in the stomach, measured by ELISA assay
Measured: Change from start of trial (time of randomization) through end of trial (12 months)
Insulin-like growth factor-1 (IGF-1)
Indicator of growth hormone action, measured by ELISA assay
Measured: Change from start of trial (time of randomization) through end of trial (12 months)
Insulin-like growth factor-binding protein 3 (IGF-BP3)
Measured by ELISA assay
Measured: Change from start of trial (time of randomization) through end of trial (12 months)
Lipoprotein insulin resistance (LPIR)
Main outcome for Specific Aim #2; a 6-component weighted score of triglyceride-rich, high-density, and low-density lipoprotein particle (TRL-P, HDL-P, LDL-P) sizes and subfraction concentrations (sum of large and very large TRL-P, large HDL-P, small LDL-P), measured by nuclear magnetic resonance spectroscopy
Measured: Change from start of trial (time of randomization) through end of trial (12 months)
Triglyceride-rich lipoprotein particle (TRL-P) size
Measured by nuclear magnetic resonance spectroscopy
Measured: Change from start of trial (time of randomization) through end of trial (12 months)
High-density lipoprotein particle (HDL-P) size
Measured by nuclear magnetic resonance spectroscopy
Measured: Change from start of trial (time of randomization) through end of trial (12 months)
Low-density lipoprotein particle (LDL-P) size
Measured by nuclear magnetic resonance spectroscopy
Measured: Change from start of trial (time of randomization) through end of trial (12 months)
Sum of large and very large TRL-P concentration
Measured by nuclear magnetic resonance spectroscopy
Measured: Change from start of trial (time of randomization) through end of trial (12 months)
Large HDL-P concentration
Measured by nuclear magnetic resonance spectroscopy
Measured: Change from start of trial (time of randomization) through end of trial (12 months)
Small LDL-P concentration
Measured by nuclear magnetic resonance spectroscopy
Measured: Change from start of trial (time of randomization) through end of trial (12 months)
Large LDL-P concentration
Measured by nuclear magnetic resonance spectroscopy
Measured: Change from start of trial (time of randomization) through end of trial (12 months)
Triglycerides (TG)
Part of conventional lipid profile
Measured: Change from start of trial (time of randomization) through end of trial (12 months)
High-density lipoprotein cholesterol (HDL-C)
Part of conventional lipid profile
Measured: Change from start of trial (time of randomization) through end of trial (12 months)
Low-density lipoprotein cholesterol (LDL-C)
Part of conventional lipid profile
Measured: Change from start of trial (time of randomization) through end of trial (12 months)
Glucose
Measured enzymatically using hexokinase method
Measured: Change from start of trial (time of randomization) through end of trial (12 months)
Insulin
Measured by electrochemiluminescence immunoassay
Measured: Change from start of trial (time of randomization) through end of trial (12 months)
Insulin resistance
Measured by homeostasis model assessment (HOMA), using fasting glucose and insulin concentrations
Measured: Change from start of trial (time of randomization) through end of trial (12 months)
Adiponectin - total and high molecular weight
Hormone released from fat cells, promotes insulin sensitivity and helps regulate blood glucose, measured by ELISA assay
Measured: Change from start of trial (time of randomization) through end of trial (12 months)
Hemoglobin A1c (HgA1c)
Marker of blood glucose control, measured using a system based turbidimetric immunoinhibition
Measured: Change from start of trial (time of randomization) through end of trial (12 months)
High-sensitivity C-reactive protein (hsCRP)
Indicator of chronic inflammation, measured by immunoturbidimetric assay
Measured: Change from start of trial (time of randomization) through end of trial (12 months)
Interleukin-6 (IL-6)
Protein which stimulates synthesis of hsCRP, measured by ELISA assay
Measured: Change from start of trial (time of randomization) through end of trial (12 months)
Fibrinogen
Protein involved in blood clotting, measured by immunoturbidimetric assay
Measured: Change from start of trial (time of randomization) through end of trial (12 months)
Plasminogen activator inhibitor-1 (PAI-1)
Protein involved in blood clotting, measured by ELISA assay
Measured: Change from start of trial (time of randomization) through end of trial (12 months)
Systolic blood pressure
Measured by auscultation
Measured: Change from start of trial (time of randomization) through end of trial (12 months)
Diastolic blood pressure
Measured by auscultation
Measured: Change from start of trial (time of randomization) through end of trial (12 months)
Salivary cariogenicity
(Ancillary Study) Risk for dental caries (cavities), measured using the GC Dental America Saliva-Check Buffer Kit (pH, flow, and buffering capacity)
Measured: Change from start of trial (time of randomization) through end of trial (12 months)
Caries prevalence
(Ancillary Study) Assessed by clinical examination and digital radiograph (x-rays)
Measured: Difference between start of trial (time of randomization) and end of trial (12 months)
Serum 25-hydroxyvitamin D [25(OH)D]
(Ancillary Study) Measured by a competitive electrochemiluminescence immunoassay
Measured: Change from start of trial (time of randomization) through end of trial (12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start28 Dec 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned for 1 year to receive home delivery of: 1) Whole milk, 3 cups a day or 2) Nonfat milk, 3 cups a day.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cara B Ebbeling, Boston Children's Hospital
- Investigators
- Cara B Ebbeling, PhD, Principal investigator, Boston Children's HospitalDavid S Ludwig, MD, PhD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05464186
- Sponsor's protocol ID
- IRB-P00041990
- Status last verified
- Oct 2025
- First submitted
- 27 Jun 2022
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share de-identified IPD on Open Science Framework.
Publications
Albala C, Ebbeling CB, Cifuentes M, Lera L, Bustos N, Ludwig DS. Effects of replacing the habitual consumption of sugar-sweetened beverages with milk in Chilean children. Am J Clin Nutr. 2008 Sep;88(3):605-11. doi: 10.1093/ajcn/88.3.605.
PubMed 18779274Ebbeling CB. Confusion at the milk cooler: opportunity to bolster the evidence base for preventive nutrition. Am J Clin Nutr. 2020 Feb 1;111(2):240-241. doi: 10.1093/ajcn/nqz319. No abstract available.
PubMed 31901161Willett WC, Ludwig DS. Milk and Health. N Engl J Med. 2020 Feb 13;382(7):644-654. doi: 10.1056/NEJMra1903547. No abstract available.
PubMed 32053300
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Whole vs. Nonfat Milk Consumption on Body Composition in Children: a 1-Year RCT
- ClinicalTrials.gov ID
- NCT05464186
- Acronym / sponsor ID
- IRB-P00041990
- Conditions
- Obesity, Diabetes, Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 28 Dec 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 19 Jul 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.
This study will evaluate the effects of whole vs. nonfat milk consumption on body composition, cardiometabolic disease risk factors, and dietary quality.
Detailed description
Background The optimal type of milk is a topic of much debate. Several recent observational studies indicate that consuming whole (full-fat), compared to reduced-fat milk, is associated with less weight gain and decreased cardiometabolic disease risk. The observed beneficial effect of consuming whole milk on body weight may be due to its greater satiety value, leading to consumption of fewer calories from other lower quality (e.g., sugary) foods. Mechanistic studies indicate that substitution of carbohydrate with certain saturated fatty acids in milk increases low-density lipoprotein cholesterol (LDL-C). However, this increase has been attributed to large, buoyant particles that are less atherogenic than small, dense particles; is accompanied by an increase in high-density lipoprotein cholesterol (HDL-C); and may not elevate overall risk compared to carbohydrate.
Specific Aims and Hypotheses
- To examine the effects of milk consumption on body composition (Aim #1) and cardiometabolic disease risk factors (Aim #2). Primary Hypothesis. Consuming whole milk will result in less weight gain compared to consuming nonfat milk. Secondary hypothesis. Consuming whole milk will decrease cardiometabolic disease risk compared to consuming nonfat milk.
- To explore the effects of milk consumption on dietary quality (Aim #3). Exploratory hypothesis. Consuming whole milk will improve overall dietary quality by displacing lower quality foods compared to consuming nonfat milk, particularly among children with low baseline dietary quality.
- (Ancillary Study) To evaluate the effects of milk consumption on risk and prevalence of dental caries.
Design Randomized Controlled Trial. Participants (N=200, aged 9 to 12 years, BMI≥75th percentile) will be randomly assigned for 1 year to receive: 1) Whole milk, 3 cups/d or 2) Nonfat milk, 3 cups/d. To promote adherence to the interventions, the investigators will rely on home delivery of milk using methods consistent with previous successful studies.
Study Outcomes The primary outcome is change in fat mass measured by air displacement plethysmography (BodPod) at 3 time points (baseline and 6 and 12 months). To evaluate cardiometabolic disease risk factors, the investigators will obtain a plasma MetaboProfile®(LabCorp) that includes lipoprotein particle sizes and subfraction concentrations, novel measures of insulin-resistant dyslipoproteinemia and inflammation, and a conventional lipid profile. The investigators will also measure blood pressure.
For the Ancillary Study, outcomes include salivary cariogenicity (pH, flow, and buffering capacity); caries prevalence; dietary quality (cariogenic potential); and serum 25-hydroxyvitamin D.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned for 1 year to receive home delivery of: 1) Whole milk, 3 cups a day or 2) Nonfat milk, 3 cups a day.
| Arm | Type | Receives |
|---|---|---|
| Whole milk | Experimental | Behavioral: Whole milk3 cups a day of whole milk for 1 year |
| Nonfat milk | Experimental | Behavioral: Nonfat milk3 cups a day of nonfat milk for 1 year |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Aged 9 to 12 years
- BMI ≥75th percentile for sex and age
- Residence in the Greater Boston catchment area
Key exclusion criteria (8 listed)
- Aversion to nonfat or whole milk
- Physician diagnosis of major medical illness, eating disorder, or milk allergy (lactose intolerance not exclusionary as lactase treated milk can be provided)
- Plans to move away from the Greater Boston catchment area during the study period
- Plans to be away from home for ≥5 weeks during the study period (e.g., extended summer vacation)
- Change in body weight exceeding 10% during prior year
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 |
|---|---|---|
| Whole milkWeekly home delivery of whole milk, daily text messages, monthly virtual visits | Behavioural | Whole milk |
| Nonfat milkWeekly home delivery of nonfat milk, daily text messages, monthly virtual visits | Behavioural | Nonfat milk |
Primary outcome
Fat mass
Time frame: Change from start of trial (time of randomization) through end of trial (12 months)
Primary outcome for the overall study, main outcome for Specific Aim #1, measured by air displacement plethysmography (BodPod)
33 secondary outcomes
Lean body mass
Time frame: Change from start of trial (time of randomization) through end of trial (12 months)
Percent body fat
Time frame: Change from start of trial (time of randomization) through end of trial (12 months)
Height
Time frame: Change from start of trial (time of randomization) through end of trial (12 months)
Body mass index (BMI)
Time frame: Change from start of trial (time of randomization) through end of trial (12 months)
Leptin
Time frame: Change from start of trial (time of randomization) through end of trial (12 months)
Ghrelin
Time frame: Change from start of trial (time of randomization) through end of trial (12 months)
Insulin-like growth factor-1 (IGF-1)
Time frame: Change from start of trial (time of randomization) through end of trial (12 months)
Insulin-like growth factor-binding protein 3 (IGF-BP3)
Time frame: Change from start of trial (time of randomization) through end of trial (12 months)
Lipoprotein insulin resistance (LPIR)
Time frame: Change from start of trial (time of randomization) through end of trial (12 months)
Triglyceride-rich lipoprotein particle (TRL-P) size
Time frame: Change from start of trial (time of randomization) through end of trial (12 months)
High-density lipoprotein particle (HDL-P) size
Time frame: Change from start of trial (time of randomization) through end of trial (12 months)
Low-density lipoprotein particle (LDL-P) size
Time frame: Change from start of trial (time of randomization) through end of trial (12 months)
Sum of large and very large TRL-P concentration
Time frame: Change from start of trial (time of randomization) through end of trial (12 months)
Large HDL-P concentration
Time frame: Change from start of trial (time of randomization) through end of trial (12 months)
Small LDL-P concentration
Time frame: Change from start of trial (time of randomization) through end of trial (12 months)
Large LDL-P concentration
Time frame: Change from start of trial (time of randomization) through end of trial (12 months)
Triglycerides (TG)
Time frame: Change from start of trial (time of randomization) through end of trial (12 months)
High-density lipoprotein cholesterol (HDL-C)
Time frame: Change from start of trial (time of randomization) through end of trial (12 months)
Low-density lipoprotein cholesterol (LDL-C)
Time frame: Change from start of trial (time of randomization) through end of trial (12 months)
Glucose
Time frame: Change from start of trial (time of randomization) through end of trial (12 months)
Insulin
Time frame: Change from start of trial (time of randomization) through end of trial (12 months)
Insulin resistance
Time frame: Change from start of trial (time of randomization) through end of trial (12 months)
Adiponectin - total and high molecular weight
Time frame: Change from start of trial (time of randomization) through end of trial (12 months)
Hemoglobin A1c (HgA1c)
Time frame: Change from start of trial (time of randomization) through end of trial (12 months)
High-sensitivity C-reactive protein (hsCRP)
Time frame: Change from start of trial (time of randomization) through end of trial (12 months)
Interleukin-6 (IL-6)
Time frame: Change from start of trial (time of randomization) through end of trial (12 months)
Fibrinogen
Time frame: Change from start of trial (time of randomization) through end of trial (12 months)
Plasminogen activator inhibitor-1 (PAI-1)
Time frame: Change from start of trial (time of randomization) through end of trial (12 months)
Systolic blood pressure
Time frame: Change from start of trial (time of randomization) through end of trial (12 months)
Diastolic blood pressure
Time frame: Change from start of trial (time of randomization) through end of trial (12 months)
Salivary cariogenicity
Time frame: Change from start of trial (time of randomization) through end of trial (12 months)
Caries prevalence
Time frame: Difference between start of trial (time of randomization) and end of trial (12 months)
Serum 25-hydroxyvitamin D [25(OH)D]
Time frame: Change from start of trial (time of randomization) through end of trial (12 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 8 Jan 2026.
- Background: PubMed 18779274Albala C, Ebbeling CB, Cifuentes M, Lera L, Bustos N, Ludwig DS. Effects of replacing the habitual consumption of sugar-sweetened beverages with milk in Chilean children. Am J Clin Nutr. 2008 Sep;88(3):605-11. doi: 10.1093/ajcn/88.3.605.
- Background: PubMed 31901161Ebbeling CB. Confusion at the milk cooler: opportunity to bolster the evidence base for preventive nutrition. Am J Clin Nutr. 2020 Feb 1;111(2):240-241. doi: 10.1093/ajcn/nqz319. No abstract available.
- Background: PubMed 32053300Willett WC, Ludwig DS. Milk and Health. N Engl J Med. 2020 Feb 13;382(7):644-654. doi: 10.1056/NEJMra1903547. No abstract available.
- Individual participant dataSharing planned: Yes. We will share de-identified IPD on Open Science Framework.
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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.
Cara B Ebbeling, PhD principal investigator
Boston Children's Hospital
David S Ludwig, MD, PhD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole milk and Nonfat milk in people with Obesity and Diabetes, run by Boston Children's Hospital at 1 site in United States.
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 8 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: looking for participants now, as of the sponsor's last update on 8 Jan 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 United States. 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?
Contact Donna L Lesperance, MA, MPH (617-919-7305, Donna.Lesperance@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fat mass (time frame: Change from start of trial (time of randomization) through end of trial (12 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05464186, which also lists 3 linked publications.
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 8 Jan 2026.