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Appetite Regulation in Older-Aged Obese Individuals

Sponsor
University of Colorado, Denver (Other)
Overall Status
Completed
CT.gov ID
NCT02721303
Collaborator
(none)
37
Enrollment
1
Location
3
Arms
54
Actual Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

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
  • Dietary Supplement: 3-day diet Run-in
  • Procedure: fMRI
  • Procedure: Intravenous catheter placed for blood draws
 N/A

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

Study Type:
Interventional
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 1, 2016
Actual Primary Completion Date :
Oct 31, 2020
Actual Study Completion Date :
Oct 31, 2020

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. neuronal response to food images [1 day]

      fMRI of brain will be done in response to images of food

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 Univeristy of Colorado Aurora Colorado United States 80045

    Sponsors and Collaborators

    • University of Colorado, Denver

    Investigators

    • Principal Investigator: Marc-Andre Cornier, MD, University of Colorado, Denver

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Colorado, Denver
    ClinicalTrials.gov Identifier:
    NCT02721303
    Other Study ID Numbers:
    • 15-1511
    First Posted:
    Mar 29, 2016
    Last Update Posted:
    Jan 6, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No

    Study Results

    No Results Posted as of Jan 6, 2021