Status:
COMPLETED
Diet, Imaging and Energy Balance Trial (DIET)
Lead Sponsor:
Duke University
Collaborating Sponsors:
Robert C. Atkins Foundation
Conditions:
Obesity
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
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 additio...
Detailed Description
We propose a parallel arm randomized clinical trial of two diets-a low carbohydrate ketogenic diet (LCKD) and a low fat diet (LFD). Following screening, eligible participants will undergo a six week d...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT00787280
Start Date
August 1 2008
End Date
November 1 2010
Last Update
February 20 2013
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27705