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Diet, Imaging and Energy Balance Trial (DIET)
This study is currently recruiting participants.
Verified by Duke University, March 2009
First Received: November 6, 2008   Last Updated: March 30, 2009   History of Changes
Sponsors and Collaborators: Duke University
Robert C. Atkins Foundation
Information provided by: Duke University
ClinicalTrials.gov Identifier: NCT00787280
  Purpose

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.


Condition
Obesity

MedlinePlus related topics: Diets Obesity
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Diet, Imaging and Energy Balance Trial

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Compared to individuals in the LFD group, individuals placed on an LCKD will exhibit decreased brain responses to high-carbohydrate food cues. [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • In addition to these questions, we will also examine relations between food consumption acquired from the diaries, genetic factors and brain function. [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

We will take a blood sample to analyze for DNA


Estimated Enrollment: 60
Study Start Date: August 2008
Groups/Cohorts
A
Low Carbohydrate
B
Low Calorie/Low Fat

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 dietary intervention that will include 7 clinic visits at the Duke Lifestyle Medicine Clinic (Director: Dr.

Westman). In addition to the dietary intervention, participants will undergo fMRI scanning on two occasions: once in the week prior to randomization to a diet (Baseline Scan) and after three weeks of following a diet (Post-Diet Scan). During scanning participants will view food cues in order to assess the effects of diet on brain responses to different macronutrient content categories (e.g., High vs. Low Complex Carbohydrate). In addition to scanning measures, we will also record information regarding dietary intake, food preferences, weight, mood, and diet adherence.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Participants will be twenty (n = 20) healthy individuals from the community who are motivated to lose weight. Approximately 60 people will be recruited in order to obtain 20 complete data sets. Participants will be required to be aged 18-50 years, have a body mass index > 27 kg/m2, and have no serious medical condition. Participants will undergo a physical examination ensuring it is safe for them to participate in both the diet and imaging components of the study.

Criteria

Inclusion Criteria:

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 Criteria:

  1. weigh over 300lbs.
  2. have uncontrolled hypertension (systolic >160mm Hg, diastolic >100mm Hg)
  3. have hypotension (systolic <90 mm Hg, diastolic <60 mm Hg)
  4. have coronary heart disease, or cardiac rhythm disorder
  5. cerebrovascular disease or peripheral vascular disease that requires intensive hyperlipidemic therapy
  6. 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)
  7. have diabetes (insulin or diet controlled)
  8. have a current psychiatric disease
  9. have current alcohol abuse (greater than 12 drinks per week)
  10. have current drug abuse (or treatment within the last year)
  11. 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)
  12. 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
  13. have had any bariatric/weight loss surgery
  14. be taking any diet pills (prescription or over the counter)
  15. have been on any diet in the last 3 months
  16. have any restrictive dietary requirements (including: vegetarians, vegans, or any other dietary restraints)
  17. have any food allergies
  18. be on an exclusively ethnic diet
  19. be females who are pregnant, nursing mothers or likely to become pregnant
  20. 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)
  21. be left handed
  22. have glaucoma, color blindness
  23. be using experimental or investigational drugs
  24. or suffering from claustrophobia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00787280

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27705
Contact: Avery Lutz     919-668-4131     lutz0011@mc.duke.edu    
Contact: Joseph McClernon     919-668-3987     mccle011@mc.duke.edu    
Principal Investigator: F. Joseph McClernon, Ph.D            
Sponsors and Collaborators
Duke University
Robert C. Atkins Foundation
Investigators
Principal Investigator: Francis J McClernon, Ph.D Duke University
  More Information

No publications provided

Responsible Party: Duke University Medical Center ( F. Joseph McClernon )
Study ID Numbers: Pro00002610
Study First Received: November 6, 2008
Last Updated: March 30, 2009
ClinicalTrials.gov Identifier: NCT00787280     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
obese
overweight
fMRI
Diet

Study placed in the following topic categories:
Body Weight
Signs and Symptoms
Obesity
Nutrition Disorders
Overnutrition
Overweight

Additional relevant MeSH terms:
Body Weight
Signs and Symptoms
Obesity
Nutrition Disorders
Overweight
Overnutrition

ClinicalTrials.gov processed this record on May 07, 2009