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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02721303
Other study ID # 15-1511
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2016
Est. completion date October 31, 2020

Study information

Verified date January 2021
Source University of Colorado, Denver
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 37
Est. completion date October 31, 2020
Est. primary completion date October 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 85 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
United States Univeristy of Colorado Aurora Colorado

Sponsors (1)

Lead Sponsor Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary neuronal response to food images fMRI of brain will be done in response to images of food 1 day
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