ObesityOPBIMNCT06353464
A Translational Understanding of Obesity-Related Phenotypes Using Brain Imaging and Manipulation
A study testing Ensure and Water in people with Obesity, run by Drexel University at 1 site in United States.
Trial summary
This study will examine a potential relationship between family history of obesity, that is whether people with at least one parent who had obesity in adulthood compared to people with two parents who did not have obesity in adulthood, and the ability of protein intake to curb further intake of food. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Ensure and Water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2023to Sep 2025
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 20-40
- weight stable for at least 3 months
- no parents with history of obesity in adulthood, or at least one parent with history of obesity in adulthood
Who cannot join
- no current diagnosis of psychiatric disorders
- no current diagnosis of neurological disorders
- no current diagnosis or history of anorexia nervosa
- no current diagnosis or history of bulimia nervosa
- no pregnancy within the last 9 months
- not currently breastfeeding
Show all 10Show fewer
- no use of investigational medication in the past 6 months
- no use of prescription anti-seizure medications.
- no use of prescription antidepressant medications
- no use of prescription antipsychotic medications
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Drexel University
Philadelphia, Pennsylvania, 19104
Principal Investigator, PhD RD, 267-359-6287, foodbrainstudies@drexel.edu
About this study
This study will examine a potential relationship between family history of obesity, that is whether people with at least one parent who had obesity in adulthood compared to people with two parents who did not have obesity in adulthood, and the ability of protein intake to curb further intake of food.
Read the detailed description
- Abstract of the study A positive energy balance (greater intake than expenditure) can explain weight gain and, when protracted, leads to overweight and obesity. The major question addressed in this proposal is if the timing of activation of specific regions of the brain is predictive of excessive food intake. Functional near infra-red spectroscopy (fNIR), seldom used in human eating studies, provides data similar to functional magnetic resonance imaging (fMRI) but allows for measurement of brain activation during food consumption. The investigator's pilot fNIR data reveal that varying patterns of regional PFC activation are associated with "loss of control" over eating, and that only 60% of individuals respond to acute protein intake with a reduction in food intake. Using fNIR and an acute protein challenge, the investigator will assess the effect of family history of obesity in humans on the satiation response to protein and concomitant activation of the prefrontal cortex (PFC). It is hypothesized that activation of the human medial PFC before the lateral PFC will result in greater intake of palatable food in those subjects with a proneness to obesity, and that these subjects will be less sensitive to the satiety-inducing effects of a protein preload. These results should provide an innovative and useful method for assessing risk for developing obesity and usefulness of preventative interventions.
- Conditions
- Obesity
- Being tested
- Ensure and Water
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ensure and WaterOther
Ensure, a liquid meal with 9 grams of protein in 8 ounces consumed 20 minutes before eating pizza; and water, 8 ounces consumed 20 minutes before eating pizza
| Study group | Role | What they receive |
|---|---|---|
| Preloads | Experimental | Delivery of two different preloads to all participants, each preload tested on a separate day/participant, prior to consumption of pizza Receives: Other: Ensure and Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grams of pizza consumed
Ad libitum during the pizza eating episode
Measured: 3-15 minutes
Baseline medial prefrontal cortex oxygenated hemoglobin
Micromoles per millimeter of oxygenated hemoglobin of the medial prefrontal cortex prior to pizza consumption
Measured: 20 minutes
Baseline lateral prefrontal cortex oxygenated hemoglobin
Micromoles per millimeter of oxygenated hemoglobin of the lateral prefrontal cortex prior to pizza consumption
Measured: 20 minutes
medial prefrontal cortex Oxygenated hemoglobin concentration
Micromoles per millimeter of oxygenated hemoglobin of the medial prefrontal cortex during pizza consumption phase
Measured: 3-15 minutes
lateral prefrontal cortex Oxygenated hemoglobin concentration
Micromoles per millimeter of oxygenated hemoglobin of the lateral prefrontal cortex during pizza consumption phase
Measured: 3-15 minutes
Secondary outcomes (3)
medial prefrontal cortex Time to Peak Light Intensity
The time in seconds that it takes for the oxygenated hemoglobin signal to reach peak in the medial prefrontal cortex during the ad libitum eating episode for each preload
Measured: 3-15 minutes
lateral prefrontal cortex Time to Peak Light Intensity
The time in seconds that it takes for the oxygenated hemoglobin signal to reach peak in the lateral prefrontal cortex during the ad libitum eating episode for each preload
Measured: 3-15 minutes
Preload Oxygenated Hemoglobin Difference
The difference between the oxygenated hemoglobin concentrations obtained under the two different preloads
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start4 Oct 2023
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- individuals consume two distinct preloads at separate sessions
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06353464
- Sponsor's protocol ID
- 2306009984
- Acronym
- OPBIM
- Status last verified
- Apr 2024
- First submitted
- 15 Feb 2024
- Last updated
- 9 Apr 2024
- 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 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Translational Understanding of Obesity-Related Phenotypes Using Brain Imaging and Manipulation
- ClinicalTrials.gov ID
- NCT06353464
- Acronym / sponsor ID
- OPBIM / 2306009984
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Study start
- 4 Oct 2023 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 9 Apr 2024 (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 examine a potential relationship between family history of obesity, that is whether people with at least one parent who had obesity in adulthood compared to people with two parents who did not have obesity in adulthood, and the ability of protein intake to curb further intake of food.
Detailed description
- Abstract of the study A positive energy balance (greater intake than expenditure) can explain weight gain and, when protracted, leads to overweight and obesity. The major question addressed in this proposal is if the timing of activation of specific regions of the brain is predictive of excessive food intake. Functional near infra-red spectroscopy (fNIR), seldom used in human eating studies, provides data similar to functional magnetic resonance imaging (fMRI) but allows for measurement of brain activation during food consumption. The investigator's pilot fNIR data reveal that varying patterns of regional PFC activation are associated with "loss of control" over eating, and that only 60% of individuals respond to acute protein intake with a reduction in food intake. Using fNIR and an acute protein challenge, the investigator will assess the effect of family history of obesity in humans on the satiation response to protein and concomitant activation of the prefrontal cortex (PFC). It is hypothesized that activation of the human medial PFC before the lateral PFC will result in greater intake of palatable food in those subjects with a proneness to obesity, and that these subjects will be less sensitive to the satiety-inducing effects of a protein preload. These results should provide an innovative and useful method for assessing risk for developing obesity and usefulness of preventative interventions.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- individuals consume two distinct preloads at separate sessions
| Arm | Type | Receives |
|---|---|---|
| Preloads | Experimental | Other: Ensure and WaterDelivery of two different preloads to all participants, each preload tested on a separate day/participant, prior to consumption of pizza |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI 20-40
- weight stable for at least 3 months
- no parents with history of obesity in adulthood, or at least one parent with history of obesity in adulthood
Key exclusion criteria (10 listed)
- no current diagnosis of psychiatric disorders
- no current diagnosis of neurological disorders
- no current diagnosis or history of anorexia nervosa
- no current diagnosis or history of bulimia nervosa
- no pregnancy within the last 9 months
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 |
|---|---|---|
| Ensure and WaterEnsure, a liquid meal with 9 grams of protein in 8 ounces consumed 20 minutes before eating pizza; and water, 8 ounces consumed 20 minutes before eating pizza | Other | Preloads |
Primary outcome
Grams of pizza consumed
Time frame: 3-15 minutes
Ad libitum during the pizza eating episode
Baseline medial prefrontal cortex oxygenated hemoglobin
Time frame: 20 minutes
Micromoles per millimeter of oxygenated hemoglobin of the medial prefrontal cortex prior to pizza consumption
Baseline lateral prefrontal cortex oxygenated hemoglobin
Time frame: 20 minutes
Micromoles per millimeter of oxygenated hemoglobin of the lateral prefrontal cortex prior to pizza consumption
medial prefrontal cortex Oxygenated hemoglobin concentration
Time frame: 3-15 minutes
Micromoles per millimeter of oxygenated hemoglobin of the medial prefrontal cortex during pizza consumption phase
lateral prefrontal cortex Oxygenated hemoglobin concentration
Time frame: 3-15 minutes
Micromoles per millimeter of oxygenated hemoglobin of the lateral prefrontal cortex during pizza consumption phase
3 secondary outcomes
medial prefrontal cortex Time to Peak Light Intensity
Time frame: 3-15 minutes
lateral prefrontal cortex Time to Peak Light Intensity
Time frame: 3-15 minutes
Preload Oxygenated Hemoglobin Difference
Time frame: 5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ensure and Water in people with Obesity, run by Drexel University 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 10 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: status not confirmed, as of the sponsor's last update on 9 Apr 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Principal Investigator, PhD RD ((267) 359 -6287, foodbrainstudies@drexel.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grams of pizza consumed (time frame: 3-15 minutes). The study lists 5 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 9 Apr 2024.