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Appetite Regulation in Older-Aged Obese Individuals

University of Colorado Denver (CU Denver) logo

University of Colorado Denver (CU Denver)

Status

Completed

Conditions

Aging
Obesity

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT02721303
15-1511

Details and patient eligibility

About

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.

Full 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.

Enrollment

37 patients

Sex

All

Ages

21 to 85 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

37 participants in 3 patient groups

obese older aged, aged 65-85, BMI 30-40
Active Comparator group
Description:
Older aged patients who are obese and between the ages of 65-85 with a BMI between 30-40.
Treatment:
Dietary Supplement: 3-day diet Run-in
Procedure: fMRI
Procedure: Intravenous catheter placed for blood draws
normal weight older aged, aged 65-85, BMI 18-25
Active Comparator group
Description:
Older aged patients who are of normal weight and between the ages of 65-85 with a BMI between 18-25.
Treatment:
Dietary Supplement: 3-day diet Run-in
Procedure: fMRI
Procedure: Intravenous catheter placed for blood draws
obese younger aged, aged 21-45, BMI 30-40
Active Comparator group
Description:
Younger aged patients who are obese and between the ages of 21-45 with a BMI between 30-40 .
Treatment:
Dietary Supplement: 3-day diet Run-in
Procedure: fMRI
Procedure: Intravenous catheter placed for blood draws

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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