Appetite Regulation in Older-Aged Obese Individuals

NCT ID: NCT02721303

Last Updated: 2021-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2020-10-31

Brief Summary

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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

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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.

Conditions

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Obesity Aging

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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obese older aged, aged 65-85, BMI 30-40

Older aged patients who are obese and between the ages of 65-85 with a BMI between 30-40.

Group Type ACTIVE_COMPARATOR

3-day diet Run-in

Intervention Type DIETARY_SUPPLEMENT

Participants will be studied on one occasion after a 3-day diet run-in. This will be followed by a breakfast meal.

fMRI

Intervention Type PROCEDURE

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 draws

Intervention Type PROCEDURE

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.

normal weight older aged, aged 65-85, BMI 18-25

Older aged patients who are of normal weight and between the ages of 65-85 with a BMI between 18-25.

Group Type ACTIVE_COMPARATOR

3-day diet Run-in

Intervention Type DIETARY_SUPPLEMENT

Participants will be studied on one occasion after a 3-day diet run-in. This will be followed by a breakfast meal.

fMRI

Intervention Type PROCEDURE

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 draws

Intervention Type PROCEDURE

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.

obese younger aged, aged 21-45, BMI 30-40

Younger aged patients who are obese and between the ages of 21-45 with a BMI between 30-40 .

Group Type ACTIVE_COMPARATOR

3-day diet Run-in

Intervention Type DIETARY_SUPPLEMENT

Participants will be studied on one occasion after a 3-day diet run-in. This will be followed by a breakfast meal.

fMRI

Intervention Type PROCEDURE

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 draws

Intervention Type PROCEDURE

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.

Interventions

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3-day diet Run-in

Participants will be studied on one occasion after a 3-day diet run-in. This will be followed by a breakfast meal.

Intervention Type DIETARY_SUPPLEMENT

fMRI

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.

Intervention Type PROCEDURE

Intravenous catheter placed for blood draws

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.

Intervention Type PROCEDURE

Other Intervention Names

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Functional Magnetic Resonance Imaging IV catheter

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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;
* 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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marc-Andre Cornier, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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Univeristy of Colorado

Aurora, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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15-1511

Identifier Type: -

Identifier Source: org_study_id

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