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Appetite Regulation in Older-Aged Obese Individuals

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02721303
Recruitment Status : Completed
First Posted : March 29, 2016
Last Update Posted : January 6, 2021
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment Phase
Obesity Aging Dietary Supplement: 3-day diet Run-in Procedure: fMRI Procedure: Intravenous catheter placed for blood draws Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Appetite Regulation in Older-Aged Obese Individuals
Actual Study Start Date : May 2016
Actual Primary Completion Date : October 31, 2020
Actual Study Completion Date : October 31, 2020
Arms and Interventions
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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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: IV catheter


Outcome Measures
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Primary Outcome Measures :
  1. neuronal response to food images [ Time Frame: 1 day ]
    fMRI of brain will be done in response to images of food


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02721303


Locations
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United States, Colorado
Univeristy of Colorado
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Marc-Andre Cornier, MD University of Colorado, Denver
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02721303    
Other Study ID Numbers: 15-1511
First Posted: March 29, 2016    Key Record Dates
Last Update Posted: January 6, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No