NCT02721303

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started May 2016

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 29, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2020

Completed
Last Updated

January 6, 2021

Status Verified

January 1, 2021

Enrollment Period

4.5 years

First QC Date

March 21, 2016

Last Update Submit

January 4, 2021

Conditions

ObesityAging

Outcome Measures

Primary Outcomes (1)

  • neuronal response to food images

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

    1 day

Study Arms (3)

obese older aged, aged 65-85, BMI 30-40

ACTIVE COMPARATOR

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-inProcedure: fMRIProcedure: Intravenous catheter placed for blood draws

normal weight older aged, aged 65-85, BMI 18-25

ACTIVE COMPARATOR

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-inProcedure: fMRIProcedure: Intravenous catheter placed for blood draws

obese younger aged, aged 21-45, BMI 30-40

ACTIVE COMPARATOR

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-inProcedure: fMRIProcedure: Intravenous catheter placed for blood draws

Interventions

3-day diet Run-inDIETARY_SUPPLEMENT

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

normal weight older aged, aged 65-85, BMI 18-25obese older aged, aged 65-85, BMI 30-40obese younger aged, aged 21-45, BMI 30-40
fMRIPROCEDURE

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.

Also known as: Functional Magnetic Resonance Imaging
normal weight older aged, aged 65-85, BMI 18-25obese older aged, aged 65-85, BMI 30-40obese younger aged, aged 21-45, BMI 30-40
Intravenous catheter placed for blood drawsPROCEDURE

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.

Also known as: IV catheter
normal weight older aged, aged 65-85, BMI 18-25obese older aged, aged 65-85, BMI 30-40obese younger aged, aged 21-45, BMI 30-40

Eligibility Criteria

Age21 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univeristy of Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Blood Specimen CollectionCatheters

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesEquipment and Supplies

Study Officials

  • Marc-Andre Cornier, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2016

First Posted

March 29, 2016

Study Start

May 1, 2016

Primary Completion

October 31, 2020

Study Completion

October 31, 2020

Last Updated

January 6, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)