Diet, Imaging and Energy Balance Trial (DIET)

Completed · Not applicable

Conditions studied: Obesity

In brief

To evaluate whether changes in macronutrient consumption (i.e., switching to a diet low in carbohydrates) can change brain responses to cues depicting foods representing that macronutrient. In addition to answering specific questions regarding the effects of an LCKD, the study will provide general information about relations between brain responses to food cues and a broad arrive of factors including typical diet, food preferences, weight control history and genes.

Key facts

Study ID

NCT00787280

Run by

Duke University

People needed

51

Starts

2008-08-01

Expected to finish

2010-11-01

Last updated by the study team

2013-02-20

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Participants must be 18-50 years old, right handed and have a BMI > 27 kg/m². They must be willing to follow either of the two diets.

You may not qualify if…

• weigh over 300lbs.
• have uncontrolled hypertension (systolic >160mm Hg, diastolic >100mm Hg)
• have hypotension (systolic <90 mm Hg, diastolic <60 mm Hg)
• have coronary heart disease, or cardiac rhythm disorder
• cerebrovascular disease or peripheral vascular disease that requires intensive hyperlipidemic therapy
• other significant co-morbid illnesses such as liver disease (AST or ALT > 100), kidney disease (serum creatinine > 1.5), cancer, severe emphysema, severe hypertriglyceridemia (TG>500)
• have diabetes (insulin or diet controlled)
• have a current psychiatric disease
• have current alcohol abuse (greater than 12 drinks per week)
• have current drug abuse (or treatment within the last year)
• use of psychiatric medications (including antidepressants, anti-anxiety agents, anti-psychotics, "muscle relaxants" or any other drug that influences mood, cognition, or neurotransmitter systems, i.e. dopamine, norepinephrine, acetylcholine, serotonin, GABA, and glutamate)
• have had or have an eating disorder including anorexia nervosa, bulimia nervosa, eating disorder not otherwise specified, binge eating disorder, or any other form of disordered eating
• have had any bariatric/weight loss surgery
• be taking any diet pills (prescription or over the counter)
• have been on any diet in the last 3 months
• have any restrictive dietary requirements (including: vegetarians, vegans, or any other dietary restraints)
• have any food allergies
• be on an exclusively ethnic diet
• be females who are pregnant, nursing mothers or likely to become pregnant
• have any major medical condition that would make participation unsafe (e.g., have pacemaker or other metallic implant (including dental, orthopedic, or IUD), uncomfortable (e.g., chronic pain), confound results (e.g., psychiatric condition)
• be left handed
• have glaucoma, color blindness
• be using experimental or investigational drugs
• or suffering from claustrophobia

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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