Pediatric ObesityNCT05391438
Impact of Meal Timing on Glycemic Profile in Latino Adolescents With Obesity
A study testing Meal-timing in people with Pediatric Obesity and Meal Timing, run by Children's Hospital Los Angeles at 1 site in United States.
Trial summary
In adolescents, conventional obesity treatment comprehensively addresses nutritional, activity, and behavioral topics. Due to limited resources in historically marginalized communities, implementation of nutrition-based interventions that require easy access to fresh food and ability to change the home environment is… Read more about this study
- Who is it for?
- Ages 13 to 19 years
- Conditions the study is for
- Pediatric Obesity, Meal Timing
- What is being tested?
- Meal-timing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2022to 1 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 13 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- age 13-19 years
- Hispanic or Latino defined by the NIH as a person of Cuban, Mexican, Puerto Rican, South or Central American, or other Spanish culture or origin, regardless of race; (3)Tanner stage III and above
- body mass index > 95th percentile (5) participant must be willing and able to adhere to the assessments, visit schedules, and eating/fasting periods.
Who cannot join
- diagnosis of Prader-Willi Syndrome, brain tumor or hypothalamic obesity
- serious intellectual disability
- parent/guardian-reported physical, mental of other inability to participate in the assessments
- previous bariatric surgery
- current use of an anti-obesity or other diabetes medication (e.g., phentermine, topiramate, orlistat, GLP-1 agonist, naltrexone, buproprion, or insulin)
- current participation in other interventional weight loss studies.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Los Angeles
Los Angeles, California, 90027
About this study
In adolescents, conventional obesity treatment comprehensively addresses nutritional, activity, and behavioral topics. Due to limited resources in historically marginalized communities, implementation of nutrition-based interventions that require easy access to fresh food and ability to change the home environment is difficult, which may exacerbate health disparities. It is critical to find nutrition strategies and recommendations that are impactful, sustainable, and cost effective across all communities. There is growing interest in time-based interventions focusing on "when" food is consumed rather than on prescribed macronutrient composition. Time-restricted eating (TRE) is a type of meal-timing which involves fasting for at least 14-hours per day and eating over a 10-hour eating window initiated in the morning, mid-day, or afternoon. TRE recommendations are simple in merely dictating when eating occurs and thus may represent a more straightforward approach for adolescents than other caloric restriction regimens relying on numeracy (kilocalories and macronutrients) and goal setting. In adults, early-day TRE has been shown to reduce body weight, fasting glucose, and insulin resistance. By contrast, restricting food intake to the evening has produced mostly null results or even worsened post prandial glucose levels and β-cell responsiveness. To date, there has been no trial comparing early vs. late TRE on glycemic profiles in adolescents, and it is unclear how meal-timing impacts glycemic profiles in youth. The optimal timing of food intake for adolescents may be very different than adults due to increasing sex steroids and growth hormone levels overnight which may contribute to increased insulin resistance in the early morning. The proposed proof-of-concept study addresses this question by measuring metabolic response to a test meal consumed in the morning, afternoon, and evening among 30 adolescents with obesity using a within participant design. These findings will provide the needed research base for the refinement of TRE interventions in adolescence.
Read the detailed description
The prevalence of type 2 diabetes in adolescents is steadily increasing, specifically among Latino youth. Unfortunately, there is a lack of effective preventative treatments available to delay the progression to type 2 diabetes in youth living with obesity and pre-diabetes. Specifically, it is challenging for many adolescents to maintain adherence to multicomponent interventions resulting in high attrition which then decreases efficacy. There is growing interest in time-based interventions focusing on "when" food is consumed rather than on prescribed macronutrient composition. In the adult population there has been increasing evidence that time-restricted eating (TRE), which consists of limiting daily food intake to an 8 to 10-hour period or less may improve insulin sensitivity and β-cell responsiveness. However the results of TRE in adults appear to depend on when eating occurs. Early TRE (last eating event prior to 16:00) has been shown to reduce body weight, fasting glucose and insulin, and insulin resistance. However, restricting food intake to the evening produced mostly null results or worsened post prandial glucose level. One possible explanation is that consuming food early in the day synchronizes the central and peripheral circadian clocks involved in energy expenditure and fat oxidation and minimizes glycemic excursions and endogenous glucose production via enhanced insulin secretion. It has been proposed that the enhanced insulin secretion may be secondary to corresponding diurnal variations in the release of incretin hormones such as glucagon, glucagon-like-peptide-1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP), and pancreatic peptide (PP).
Because of its simplicity, TRE may represent a more feasible approach for adolescents than other caloric restriction regimens. Our team recently conducted the first study examining the feasibility of TRE in adolescents with obesity. In this study, fifty adolescents were randomized to a self-selected 8-hour TRE compared to a prolonged eating window. TRE was found to be feasible, safe, and acceptable but there was no difference in glycemic profiles or weight loss between groups. These null findings may be due to the late eating window that was selected. To date, there have been no trial comparing early vs. late TRE on glycemic profiles in adolescents and it is unclear how meal-timing impacts glycemic profiles in youth. It remains unknown how the timing of meal consumption directly effects glycemic profiles and cardiometabolic endpoints in this age group. Thus, to address this question, in our proof-of-concept study, the investigators aim to measure glycemic and metabolic responses to a test meal (controlled for macronutrient profile and caloric amount) at various meal-timings (early vs. afternoon vs. late) in thirty Latino adolescents (ages 13-19 years), with obesity, without diabetes. All participants will consume three standard test meals administered in random order at different times of day over a two-week period: (1) Early: test meal consumed at 8 AM; (2) Afternoon: 12 PM; (3) Late: 4 PM. Test meals will be consumed on different days at least three days apart after a minimum of a 16-hour fasting period. A continuous glucose monitor (CGM) will be placed on the participant for the duration of the 2-week period. The primary endpoints will be frequently sampled glucose, insulin, and c-peptide area under the curve (AUC) collected after consumption of a standard test meal, insulinogenic index (IGI: change in insulin/change in glucose over the first 30 min after the load), and glucose variability as captured by percent time in range on CGM. The investigators hypothesize that adolescents with obesity will have reduced AUC and IGI following the later meals compared to the early meal. The investigators will test these hypotheses with the following aims:
Aim 1: Identify how timing of meal consumption after a prolonged 16-h fast affects glucose and insulin response in Latino adolescents with obesity. The investigators will measure insulin secretion, clearance rates, and sensitivity assessed with a) 3-h frequent sampling of glucose, insulin, and c-peptide post meal, b) calculated insulinogenic index, and c) percent time in range measured by CGM. The investigators expect that meal consumption at 12 and 4 PM will be associated with lower post prandial glucose excursions, decreased AUC and IGI, and increased percent time in range compared to that same meal consumed at 8 AM.
Aim 2: Examine the association between timing of meal consumption and incretin and pancreatic hormones in Latino adolescents with obesity. The investigators will collect frequent sampling of glucagon, total GLP-1, GIP, and PP concentrations post-meal to explore how diurnal variation in these hormones impact insulin sensitivity. The investigators expect that meal consumption at 12 and 4 PM will in greater change in incretin and pancreatic hormones concentrations compared to that same meals consumed at 8 AM.
Future Direction: The data collected during this pilot will inform the design of a randomized clinical trial to test the feasibility, safety, and efficacy of early vs. late TRE in adolescents with obesity to reduce glycemic and insulin response for the prevention of type 2 diabetes.
- Conditions
- Pediatric Obesity, Meal Timing
- Being tested
- Meal-timing
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meal-timingOther
We propose a cross-over, proof-of-concept study to measure glycemic and metabolic responses to a test meal (controlled for macronutrient profile and caloric amount) administered at various times of the day (early vs. afternoon vs. late) in thirty Latino adolescents (ages 13-19 years), with obesity, without diabetes, to determine how timing of eating impacts glycemic response to the test meal after a 16-h fasting period. All participants will consume three standard test meals administered in random order at different times of day over two-weeks: (1) Early: test meal consumed at 8 AM; (2) Afternoon: test meal consumed at 12 PM; (3) Late: test meal consumed at 4 PM. A continuous glucose monitor (CGM) will be placed on the participant for the duration of the 2-week period. Baseline and post-meal samples will be assayed for glucose, insulin, c-peptide, GLP-1, GIP, PP at times -10, -5, 0, 10, 20, 30, 45, 60, 90, 120, 150 and 180 minutes after glucose.
| Study group | Role | What they receive |
|---|---|---|
| Meal-timing | Other | All participants will consume three standard test meals administered in random order at different times of day over two-weeks: (1) Early: test meal consumed at 8 AM; (2) Afternoon: test meal consumed at 12 PM; (3) Late: test meal consumed at 4 PM. A continuous glucose monitor (CGM) will be placed on the participant for the duration of the 2-week period. Receives: Other: Meal-timing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Insulinogenic Index From Baseline After Test Meal From Venous Sample
Baseline and post-meal samples will be assayed for glucose, insulin, and c-peptide at times -10, -5, 0, 10, 20, 30, 45, 60, 90, 120, 150 and 180 minutes after the meal is consumed. The Insulinogenic index (change in insulin/change in glucose over the first 30 min after the load) will be calculated. IGI has been widely used as an index of early phase insulin secretion in clinical studies. It is highly correlated with the acute insulin response on intravenous glucose tolerance test and is considered a reasonable surrogate.
Measured: Baseline to Day 14
Change in Incremental Glucose Area Under the Curve From Baseline After Test Meal From Venous Sample
Glucose incremental area under curve: The positive area under the post-meal glucose curve after subtracting the glucose value at the start.
Measured: Baseline to Day 14
Secondary outcomes (1)
Change in Quantifying Glucagon Like Peptide 1 Concentrations From Baseline After Test Meal From Venous Sample
Glucagon like peptide 1 concentrations will be measured in duplicate from plasma samples using Millipore Enzyme-linked Immunosorbent Assays (ELISA) or multiplex assays according to the recommendations of the manufacturer (Birmington, MA).
Measured: Baseline to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start1 Sep 2022
- Primary completion1 Aug 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- More trials run by Children's Hospital Los AngelesThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- proof-of-concept study to measure glycemic and metabolic responses to a test meal (controlled for macronutrient profile and caloric amount) administered at various times of the day (early vs. afternoon vs. late) in thirty Latino adolescents. All participants will consume three standard test meals administered in random order at different times of day over two-weeks: (1) Early: test meal consumed at 8 AM; (2) Afternoon: test meal consumed at 12 PM; (3) Late: test meal consumed at 4 PM. A continuous glucose monitor (CGM) will be placed on the participant for the duration of the 2-week period. Baseline and post-meal samples will be assayed for glucose, insulin, c-peptide, GLP-1, GIP, PP at times -10, -5, 0, 10, 20, 30, 45, 60, 90, 120, 150 and 180 minutes after glucose. The primary endpoints will be glucose, insulin, and C-peptide area under the curve, insulinogenic index, and glucose variability as captured by percent time in range on CGM following the test meal.
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaina P. Vidmar, MD, Children's Hospital Los Angeles
- Investigators
- Alaina Vidmar, MD, Principal investigator, Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05391438
- Sponsor's protocol ID
- CHLA-22-00119
- Status last verified
- Oct 2024
- First submitted
- 19 May 2022
- Last updated
- 23 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Meal Timing on Glycemic Profile in Latino Adolescents With Obesity
- ClinicalTrials.gov ID
- NCT05391438
- Acronym / sponsor ID
- CHLA-22-00119
- Conditions
- Pediatric Obesity, Meal Timing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Children's Hospital Los AngelesUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 26 May 2022 (actual)
- Results
- Posted 23 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In adolescents, conventional obesity treatment comprehensively addresses nutritional, activity, and behavioral topics. Due to limited resources in historically marginalized communities, implementation of nutrition-based interventions that require easy access to fresh food and ability to change the home environment is difficult, which may exacerbate health disparities. It is critical to find nutrition strategies and recommendations that are impactful, sustainable, and cost effective across all communities. There is growing interest in time-based interventions focusing on "when" food is consumed rather than on prescribed macronutrient composition. Time-restricted eating (TRE) is a type of meal-timing which involves fasting for at least 14-hours per day and eating over a 10-hour eating window initiated in the morning, mid-day, or afternoon. TRE recommendations are simple in merely dictating when eating occurs and thus may represent a more straightforward approach for adolescents than other caloric restriction regimens relying on numeracy (kilocalories and macronutrients) and goal setting. In adults, early-day TRE has been shown to reduce body weight, fasting glucose, and insulin resistance. By contrast, restricting food intake to the evening has produced mostly null results or even worsened post prandial glucose levels and β-cell responsiveness. To date, there has been no trial comparing early vs. late TRE on glycemic profiles in adolescents, and it is unclear how meal-timing impacts glycemic profiles in youth. The optimal timing of food intake for adolescents may be very different than adults due to increasing sex steroids and growth hormone levels overnight which may contribute to increased insulin resistance in the early morning. The proposed proof-of-concept study addresses this question by measuring metabolic response to a test meal consumed in the morning, afternoon, and evening among 30 adolescents with obesity using a within participant design. These findings will provide the needed research base for the refinement of TRE interventions in adolescence.
Detailed description
The prevalence of type 2 diabetes in adolescents is steadily increasing, specifically among Latino youth. Unfortunately, there is a lack of effective preventative treatments available to delay the progression to type 2 diabetes in youth living with obesity and pre-diabetes. Specifically, it is challenging for many adolescents to maintain adherence to multicomponent interventions resulting in high attrition which then decreases efficacy. There is growing interest in time-based interventions focusing on "when" food is consumed rather than on prescribed macronutrient composition. In the adult population there has been increasing evidence that time-restricted eating (TRE), which consists of limiting daily food intake to an 8 to 10-hour period or less may improve insulin sensitivity and β-cell responsiveness. However the results of TRE in adults appear to depend on when eating occurs. Early TRE (last eating event prior to 16:00) has been shown to reduce body weight, fasting glucose and insulin, and insulin resistance. However, restricting food intake to the evening produced mostly null results or worsened post prandial glucose level. One possible explanation is that consuming food early in the day synchronizes the central and peripheral circadian clocks involved in energy expenditure and fat oxidation and minimizes glycemic excursions and endogenous glucose production via enhanced insulin secretion. It has been proposed that the enhanced insulin secretion may be secondary to corresponding diurnal variations in the release of incretin hormones such as glucagon, glucagon-like-peptide-1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP), and pancreatic peptide (PP).
Because of its simplicity, TRE may represent a more feasible approach for adolescents than other caloric restriction regimens. Our team recently conducted the first study examining the feasibility of TRE in adolescents with obesity. In this study, fifty adolescents were randomized to a self-selected 8-hour TRE compared to a prolonged eating window. TRE was found to be feasible, safe, and acceptable but there was no difference in glycemic profiles or weight loss between groups. These null findings may be due to the late eating window that was selected. To date, there have been no trial comparing early vs. late TRE on glycemic profiles in adolescents and it is unclear how meal-timing impacts glycemic profiles in youth. It remains unknown how the timing of meal consumption directly effects glycemic profiles and cardiometabolic endpoints in this age group. Thus, to address this question, in our proof-of-concept study, the investigators aim to measure glycemic and metabolic responses to a test meal (controlled for macronutrient profile and caloric amount) at various meal-timings (early vs. afternoon vs. late) in thirty Latino adolescents (ages 13-19 years), with obesity, without diabetes. All participants will consume three standard test meals administered in random order at different times of day over a two-week period: (1) Early: test meal consumed at 8 AM; (2) Afternoon: 12 PM; (3) Late: 4 PM. Test meals will be consumed on different days at least three days apart after a minimum of a 16-hour fasting period. A continuous glucose monitor (CGM) will be placed on the participant for the duration of the 2-week period. The primary endpoints will be frequently sampled glucose, insulin, and c-peptide area under the curve (AUC) collected after consumption of a standard test meal, insulinogenic index (IGI: change in insulin/change in glucose over the first 30 min after the load), and glucose variability as captured by percent time in range on CGM. The investigators hypothesize that adolescents with obesity will have reduced AUC and IGI following the later meals compared to the early meal. The investigators will test these hypotheses with the following aims:
Aim 1: Identify how timing of meal consumption after a prolonged 16-h fast affects glucose and insulin response in Latino adolescents with obesity. The investigators will measure insulin secretion, clearance rates, and sensitivity assessed with a) 3-h frequent sampling of glucose, insulin, and c-peptide post meal, b) calculated insulinogenic index, and c) percent time in range measured by CGM. The investigators expect that meal consumption at 12 and 4 PM will be associated with lower post prandial glucose excursions, decreased AUC and IGI, and increased percent time in range compared to that same meal consumed at 8 AM.
Aim 2: Examine the association between timing of meal consumption and incretin and pancreatic hormones in Latino adolescents with obesity. The investigators will collect frequent sampling of glucagon, total GLP-1, GIP, and PP concentrations post-meal to explore how diurnal variation in these hormones impact insulin sensitivity. The investigators expect that meal consumption at 12 and 4 PM will in greater change in incretin and pancreatic hormones concentrations compared to that same meals consumed at 8 AM.
Future Direction: The data collected during this pilot will inform the design of a randomized clinical trial to test the feasibility, safety, and efficacy of early vs. late TRE in adolescents with obesity to reduce glycemic and insulin response for the prevention of type 2 diabetes.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- proof-of-concept study to measure glycemic and metabolic responses to a test meal (controlled for macronutrient profile and caloric amount) administered at various times of the day (early vs. afternoon vs. late) in thirty Latino adolescents. All participants will consume three standard test meals administered in random order at different times of day over two-weeks: (1) Early: test meal consumed at 8 AM; (2) Afternoon: test meal consumed at 12 PM; (3) Late: test meal consumed at 4 PM. A continuous glucose monitor (CGM) will be placed on the participant for the duration of the 2-week period. Baseline and post-meal samples will be assayed for glucose, insulin, c-peptide, GLP-1, GIP, PP at times -10, -5, 0, 10, 20, 30, 45, 60, 90, 120, 150 and 180 minutes after glucose. The primary endpoints will be glucose, insulin, and C-peptide area under the curve, insulinogenic index, and glucose variability as captured by percent time in range on CGM following the test meal.
| Arm | Type | Receives |
|---|---|---|
| Meal-timing | Other | Other: Meal-timingAll participants will consume three standard test meals administered in random order at different times of day over two-weeks: (1) Early: test meal consumed at 8 AM; (2) Afternoon: test meal consumed at 12 PM; (3) Late: test meal consumed at 4 PM. A continuous glucose monitor (CGM) will be placed on the participant for the duration of the 2-week period. |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- age 13-19 years
- Hispanic or Latino defined by the NIH as a person of Cuban, Mexican, Puerto Rican, South or Central American, or other Spanish culture or origin, regardless of race; (3)Tanner stage III and above
- body mass index > 95th percentile (5) participant must be willing and able to adhere to the assessments, visit schedules, and eating/fasting periods.
Key exclusion criteria (6 listed)
- diagnosis of Prader-Willi Syndrome, brain tumor or hypothalamic obesity
- serious intellectual disability
- parent/guardian-reported physical, mental of other inability to participate in the assessments
- previous bariatric surgery
- current use of an anti-obesity or other diabetes medication (e.g., phentermine, topiramate, orlistat, GLP-1 agonist, naltrexone, buproprion, or insulin)
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-timingWe propose a cross-over, proof-of-concept study to measure glycemic and metabolic responses to a test meal (controlled for macronutrient profile and caloric amount) administered at various times of the day (early vs. afternoon vs. late) in thirty Latino adolescents (ages 13-19 years), with obesity, without diabetes, to determine how timing of eating impacts glycemic response to the test meal after a 16-h fasting period. All participants will consume three standard test meals administered in random order at different times of day over two-weeks: (1) Early: test meal consumed at 8 AM; (2) Afternoon: test meal consumed at 12 PM; (3) Late: test meal consumed at 4 PM. A continuous glucose monitor (CGM) will be placed on the participant for the duration of the 2-week period. Baseline and post-meal samples will be assayed for glucose, insulin, c-peptide, GLP-1, GIP, PP at times -10, -5, 0, 10, 20, 30, 45, 60, 90, 120, 150 and 180 minutes after glucose. | Other | Meal-timing |
Primary outcome
Change in Insulinogenic Index From Baseline After Test Meal From Venous Sample
Time frame: Baseline to Day 14
Baseline and post-meal samples will be assayed for glucose, insulin, and c-peptide at times -10, -5, 0, 10, 20, 30, 45, 60, 90, 120, 150 and 180 minutes after the meal is consumed. The Insulinogenic index (change in insulin/change in glucose over the first 30 min after the load) will be calculated. IGI has been widely used as an index of early phase insulin secretion in clinical studies. It is highly correlated with the acute insulin response on intravenous glucose tolerance test and is considered a reasonable surrogate.
Change in Incremental Glucose Area Under the Curve From Baseline After Test Meal From Venous Sample
Time frame: Baseline to Day 14
Glucose incremental area under curve: The positive area under the post-meal glucose curve after subtracting the glucose value at the start.
1 secondary outcome
Change in Quantifying Glucagon Like Peptide 1 Concentrations From Baseline After Test Meal From Venous Sample
Time frame: Baseline to Day 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Alaina Vidmar, MD principal investigator
Children's Hospital Los Angeles
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-timing in people with Pediatric Obesity and Meal Timing, run by Children's Hospital Los Angeles 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 6 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 23 Oct 2024. 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?
Yes. Results are posted in the registry (first posted 23 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Insulinogenic Index From Baseline After Test Meal From Venous Sample (time frame: Baseline to Day 14). The study lists 2 primary outcomes in all. 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 23 Oct 2024.