ObesityNCT02721303
Appetite Regulation in Older-Aged Obese Individuals
A study testing 3-day diet Run-in, fMRI and Intravenous catheter placed for blood draws in people with Obesity and Aging, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study plans to learn more about how age and weight impact appetite and food intake. Specifically, this study is being done to see whether age and obesity impact appetite and the brain's response to food. Read more about this study
- Who is it for?
- Ages 21 to 85 yearsHealthy volunteers can take part
- What is being tested?
- 3-day diet Run-in, fMRI and Intravenous catheter placed for blood draws
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to 31 Oct 2020
- 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 21 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Older aged adults (O): 65-85
- Younger adults (Y): 21-45
- Obese (Ob): body mass index (BMI) 30-40
- Normal Weight (NW): BMI 18-25
Who cannot join
- Pregnancy;
- Advanced organ failure;
- Active cancer diagnosis;
- Uncontrolled hypertension or metabolic disorder;
- Cognitive impairment or psychiatric disease limiting ability to comply;
- Presently in an exercise or diet program;
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- Recent weight loss of >5 lbs in past 6 mo.;
- Bariatric surgery;
- Use of any weight loss drugs;
- Use of any medication known to significantly affect appetite (anti-depressants are allowable);
- Present tobacco use;
- Use/abuse of substances of abuse including any marijuana use by history;
- Any contraindication to MRI;
- Claustrophobia;
- Body weight >300 lbs; and
- Inability to fit in MRI scanner.
Trial locations and contacts
1 site in 1 country.
About this study
This study plans to learn more about how age and weight impact appetite and food intake. Specifically, this study is being done to see whether age and obesity impact appetite and the brain's response to food. In this study the investigators will be evaluating how participants brains respond to food images as well as your food-related behaviors and hormones. The investigators will be comparing older individuals aged 65 to 85 years who are normal weight compared to those who are obese. The Investigators will then compare older aged individuals to younger adults aged 21 to 45 years.
Read the detailed description
In a cross sectional design participants will be studied on one occasion after a 3-day diet run-in. On the study day they will present in the fasting state, have an intravenous catheter placed for blood draws and have baseline blood samples taken and appetite measures performed. Participants will then undergo functional magnetic resonance imaging (fMRI). This will be followed by a breakfast meal. Blood and appetite measures will be performed every half hour for 3 hours. Repeat fMRI will be performed 30 minutes after the meal. After three hours participants will be offered a buffet style lunch and then will be done with the study visit.
- Being tested
- 3-day diet Run-in, fMRI, Intravenous catheter placed for blood draws
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-day diet Run-inDietary supplement
Participants will be studied on one occasion after a 3-day diet run-in. This will be followed by a breakfast meal.
fMRIProcedure or surgery
Also called Functional Magnetic Resonance Imaging
After a 3-day diet run-in, participants will undergo a functional magnetic resonance imaging procedure (fMRI). Repeat fMRI will be performed 30 minutes after the meal.
Intravenous catheter placed for blood drawsProcedure or surgery
Also called IV catheter
On the study day participants will present in the fasting state, have an intravenous catheter placed for blood draws and have baseline blood samples taken. Blood and appetite measures will be performed every half hour for 3 hours.
| Study group | Role | What they receive |
|---|---|---|
| obese older aged, aged 65-85, BMI 30-40 | Active comparator | Older aged patients who are obese and between the ages of 65-85 with a BMI between 30-40. Receives: Dietary Supplement: 3-day diet Run-in; Procedure: fMRI; Procedure: Intravenous catheter placed for blood draws |
| normal weight older aged, aged 65-85, BMI 18-25 | Active comparator | Older aged patients who are of normal weight and between the ages of 65-85 with a BMI between 18-25. Receives: Dietary Supplement: 3-day diet Run-in; Procedure: fMRI; Procedure: Intravenous catheter placed for blood draws |
| obese younger aged, aged 21-45, BMI 30-40 | Active comparator | Younger aged patients who are obese and between the ages of 21-45 with a BMI between 30-40 . Receives: Dietary Supplement: 3-day diet Run-in; Procedure: fMRI; Procedure: Intravenous catheter placed for blood draws |
What is being measured
The primary outcome is the main question the study is designed to answer.
neuronal response to food images
fMRI of brain will be done in response to images of food
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2016 (estimated)
- Study startMay 2016
- Primary completion31 Oct 2020
- Study completion31 Oct 2020
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.
- More trials run by University of Colorado, DenverThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc-Andre Cornier, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02721303
- Sponsor's protocol ID
- 15-1511
- Status last verified
- Jan 2021
- First submitted
- 21 Mar 2016
- Last updated
- 6 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Appetite Regulation in Older-Aged Obese Individuals
- ClinicalTrials.gov ID
- NCT02721303
- Acronym / sponsor ID
- 15-1511
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 29 Mar 2016 (estimated)
- 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 plans to learn more about how age and weight impact appetite and food intake. Specifically, this study is being done to see whether age and obesity impact appetite and the brain's response to food. In this study the investigators will be evaluating how participants brains respond to food images as well as your food-related behaviors and hormones. The investigators will be comparing older individuals aged 65 to 85 years who are normal weight compared to those who are obese. The Investigators will then compare older aged individuals to younger adults aged 21 to 45 years.
Detailed description
In a cross sectional design participants will be studied on one occasion after a 3-day diet run-in. On the study day they will present in the fasting state, have an intravenous catheter placed for blood draws and have baseline blood samples taken and appetite measures performed. Participants will then undergo functional magnetic resonance imaging (fMRI). This will be followed by a breakfast meal. Blood and appetite measures will be performed every half hour for 3 hours. Repeat fMRI will be performed 30 minutes after the meal. After three hours participants will be offered a buffet style lunch and then will be done with the study visit.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| obese older aged, aged 65-85, BMI 30-40 | Active comparator | Dietary Supplement: 3-day diet Run-in, Procedure: fMRI, Procedure: Intravenous catheter placed for blood drawsOlder aged patients who are obese and between the ages of 65-85 with a BMI between 30-40. |
| normal weight older aged, aged 65-85, BMI 18-25 | Active comparator | Dietary Supplement: 3-day diet Run-in, Procedure: fMRI, Procedure: Intravenous catheter placed for blood drawsOlder aged patients who are of normal weight and between the ages of 65-85 with a BMI between 18-25. |
| obese younger aged, aged 21-45, BMI 30-40 | Active comparator | Dietary Supplement: 3-day diet Run-in, Procedure: fMRI, Procedure: Intravenous catheter placed for blood drawsYounger aged patients who are obese and between the ages of 21-45 with a BMI between 30-40 . |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Older aged adults (O): 65-85
- Younger adults (Y): 21-45
- Obese (Ob): body mass index (BMI) 30-40
- Normal Weight (NW): BMI 18-25
Key exclusion criteria (16 listed)
- Pregnancy;
- Advanced organ failure;
- Active cancer diagnosis;
- Uncontrolled hypertension or metabolic disorder;
- Cognitive impairment or psychiatric disease limiting ability to comply;
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 |
|---|---|---|
| 3-day diet Run-inParticipants will be studied on one occasion after a 3-day diet run-in. This will be followed by a breakfast meal. | Dietary supplement | normal weight older aged, aged 65-85, BMI 18-25, obese older aged, aged 65-85, BMI 30-40, obese younger aged, aged 21-45, BMI 30-40 |
| fMRIAlso: Functional Magnetic Resonance ImagingAfter a 3-day diet run-in, participants will undergo a functional magnetic resonance imaging procedure (fMRI). Repeat fMRI will be performed 30 minutes after the meal. | Procedure or surgery | normal weight older aged, aged 65-85, BMI 18-25, obese older aged, aged 65-85, BMI 30-40, obese younger aged, aged 21-45, BMI 30-40 |
| Intravenous catheter placed for blood drawsAlso: IV catheterOn the study day participants will present in the fasting state, have an intravenous catheter placed for blood draws and have baseline blood samples taken. Blood and appetite measures will be performed every half hour for 3 hours. | Procedure or surgery | normal weight older aged, aged 65-85, BMI 18-25, obese older aged, aged 65-85, BMI 30-40, obese younger aged, aged 21-45, BMI 30-40 |
Primary outcome
neuronal response to food images
Time frame: 1 day
fMRI of brain will be done in response to images of food
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 6 Jan 2021.
- 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.
Marc-Andre Cornier, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3-day diet Run-in, fMRI and Intravenous catheter placed for blood draws in people with Obesity and Aging, run by University of Colorado, Denver 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 4 inclusion and 16 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 6 Jan 2021. 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?
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?
neuronal response to food images (time frame: 1 day). 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 6 Jan 2021.