Effect of Metabolic State on Anxiety in Human Subjects

NCT01322243 | Terminated

• 1 other identifier: EKE-0724
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, we would like to explore the hypothesis that changes in metabolic state, induced by altering hormone levels and patterns of neural activity, affect the experience of anxiety in humans. We will also investigate if there is a link between high anxiety and higher caloric intake. Our aim is to characterize whether changes in current metabolic state systematically influence anxiety induced by a well established behavioral task known as the threat of shock. The neural regions activated by this behavioral task in healthy subjects have been well characterized. We have a priori regions of interest that include the insula, anterior cingulate cortex, hypothalamus, amygdala, and prefrontal cortex. As our primary outcome, we will assess neural activation with whole-brain functional magnetic resonance imaging to determine whether brain regions are differentially engaged when subjects experience anxiety across different metabolic states. We will correlate these changes with psychophysiological measures of anxiety and metabolic state.

Conditions

Healthy Volunteers

Keywords

Anxiety; Metabolic state; Stress

Outcome Measures

Primary Outcomes (1)

• Functional magnetic resonance imaging (fMRI) blood oxygenation level dependent (BOLD) signals as indications of neural activity during exposure to an anxiety-inducing stress.

  4 years

Secondary Outcomes (2)

• Physiological and behavioral parameters of emotional and metabolic state.

  4 years

• Response inhibition (impulse control) is also a secondary outcome for this study

  4 years

Study Arms (2)

Dietary Intervention: Fasted State

OTHER

Participants will be randomized to a dietary intervention of a fasted or fed group upon admission.

Other: Dietary manipulation

Dietary Intervention: Fed State

OTHER

Participants will be randomized to a dietary intervention of a fasted or fed group upon admission

Other: Dietary manipulation

Interventions

Dietary manipulation OTHER

Participants are maintained in a fasted (only noncaloric beverages) or fed (isocaloric weight-maintenance diet) state for two days.

Dietary Intervention: Fasted State; Dietary Intervention: Fed State

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women aged 20 - 40 years.
• Body Mass Index (BMI) from 19.0 to 25.0 for the lean population or Body Mass Index (BMI) equal to or greater than 30 for the obese population and under 300lbs (136.07kg.)
• Fluent in English
• Females must report a normal menstrual cycle length defined as from 24-35 days, with a period lasting from 2-7 days
• Stable weight (+/- 5 %) for at least three months prior to each admission and under 300 lbs (136.07kg.)

You may not qualify if:

• Weight of \> 300 lbs (136.07kg.)
• Patients may not have had \> 550 mL of blood drawn within 8 weeks of study entry.
• Less than 8 weeks after receiving an investigational new drug (IND). Patients must have a minimum of an 8 week washout period.
• Left-handedness.
• Any employee of Rockefeller University who knows the details of this study
• Reported history of claustrophobia.
• Reported history of metal implants, pacemaker, IUD, braces, or tattoos less then 6 months old.
• Reported history of smoking, chewing tobacco or use of nicotine patches within the previous 3 months.
• Reported history of alcohol abuse/dependence.
• Reported use of prescription medication for pain, anxiety or sleep more than once a week.
• Reported daily ingestion of herbal (including melatonin) or dietary supplements within one month prior to the screening.
• Reported use of medications or herbal supplements that affect appetite or body weight within the previous three months.
• Reported history of using the following medications: glucocorticoids, anti-seizure medications, thyroid hormones in the past six months.
• Reported Psychiatric disorder requiring medication or treatment.
• Reported history of cardiac disease.

Sponsors & Collaborators

• Rockefeller University: lead

Study Sites (1)

The Rockefeller University

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Ana Emiliano, MD

  The Rockefeller University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 22, 2011
• First Posted: March 24, 2011
• Study Start: March 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: May 20, 2013

Record last verified: 2013-05

Locations

US (1)