Appetite Regulation in Older-Aged Obese Individuals

• ClinicalTrials.gov Identifier: NCT02721303
• Recruitment Status: Completed
• First Posted: March 29, 2016
• Last Update Posted: January 6, 2021
• Sponsor: University of Colorado, Denver
• Information provided by (Responsible Party): University of Colorado, Denver

Tracking Information

• First Submitted Date: March 21, 2016
• First Posted Date: March 29, 2016
• Last Update Posted Date: January 6, 2021
• Actual Study Start Date: May 2016
• Actual Primary Completion Date: October 31, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 23, 2016)

neuronal response to food images [ Time Frame: 1 day ]

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

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Appetite Regulation in Older-Aged Obese Individuals
• Official Title: Appetite Regulation in Older-Aged Obese Individuals
• 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.
• 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
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Basic Science

Condition

• Obesity
• Aging

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.
  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

Study Arms

• 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.
  Interventions:

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

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

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 4, 2021): 37
• Original Estimated Enrollment (submitted: March 23, 2016): 66
• Actual Study Completion Date: October 31, 2020
• Actual Primary Completion Date: October 31, 2020 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02721303
• Other Study ID Numbers: 15-1511
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: University of Colorado, Denver
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Colorado, Denver
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: University of Colorado, Denver
• Verification Date: January 2021