Appetite Regulation in Older-Aged Obese Individuals

January 4, 2021 updated by: University of Colorado, Denver
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Univeristy of Colorado

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Dietary supplement: 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.
Procedure: 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.
Other Names:
  • Functional Magnetic Resonance Imaging
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.
Other Names:
  • IV catheter
Active Comparator: 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.
Dietary supplement: 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.
Procedure: 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.
Other Names:
  • Functional Magnetic Resonance Imaging
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.
Other Names:
  • IV catheter
Active Comparator: 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 .
Dietary supplement: 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.
Procedure: 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.
Other Names:
  • Functional Magnetic Resonance Imaging
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.
Other Names:
  • IV catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
neuronal response to food images
Time Frame: 1 day
fMRI of brain will be done in response to images of food
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Actual)

October 31, 2020

Study Completion (Actual)

October 31, 2020

Study Registration Dates

First Submitted

March 21, 2016

First Submitted That Met QC Criteria

March 23, 2016

First Posted (Estimate)

March 29, 2016

Study Record Updates

Last Update Posted (Actual)

January 6, 2021

Last Update Submitted That Met QC Criteria

January 4, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 15-1511

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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