Effect of Metabolic State on Anxiety in Human Subjects

Stopped early · Not applicable

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT01322243

Run by

Rockefeller University

People needed

10

Starts

2011-03-01

Expected to finish

2013-02-01

Last updated by the study team

2013-05-20

Who can join

Age: 20 and older, up to 40. Sex: any. Healthy volunteers: accepted.

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.
• Reported history of illnesses that affect metabolic hormone levels: renal or hepatic failure, type 1 or type 2 diabetes, lymphoma, hypogonadism, malabsorption/malnourishment, hypo- or hyper-thyroidism, hypercortisolism or any endocrinopathies.
• Reported history of physical exercise >2 hours per day.
• Reported history by female subjects of amenorrhea (no periods for longer than 3 months (even with negative uhCG) and oligomenorrhea (length greater than 35 days.)
• Pregnant (verified by urine hCG) or breast-feeding within the past 3 months.
• Eating disorder as suggested by at least 2 'yes' answers on the SCOFF Eating Disorder Questionnaire.
• Alcohol dependence as suggested by at least 2 'yes' answers on the CAGE Questionnaire.
• Current use of any illicit drug (including "recreational use") as verified by urine toxicology test.
• Anemia defined as Hgb < 12g/dL for male subjects < 11g/d/L for female subjects.
• TSH level that is outside the reference range of 0.3 - 0.5 mU/L or free T4 level that is outside the reference range of 4.5 - 11.2 mcg/dL (performed only if an abnormal thyroid gland identified on physical examination.)
• History, physical, social or lab findings suggestive of any medical or psychological condition that would, in the opinion of the PI, make the candidate ineligible for the study.

Where it is running

• The Rockefeller University — New York, New York, United States

Full record on ClinicalTrials.gov

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