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OpenTrials
Completed

NCT Number: NCT02721303

Appetite Regulation in Older-Aged Obese Individuals

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.

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Key information

Age range

21 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Univeristy of Colorado

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

3-day diet Run-in

Dietary Supplement

Participants will be studied on one occasion after a 3-day diet run-in. This will be followed by a breakfast meal.

fMRI

Procedure

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

Intravenous catheter placed for blood draws

Procedure

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

Primary outcomes

  1. neuronal response to food images

    Time frame: 1 day

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

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Mar 29, 2016
Registry last updated
Jan 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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