Diet, Imaging and Energy Balance Trial (DIET)

This study has been completed.
Sponsor:
Collaborator:
Robert C. Atkins Foundation
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00787280
First received: November 6, 2008
Last updated: February 18, 2013
Last verified: February 2013
  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 Intervention
Obesity
Behavioral: Low Carbohydrate Ketogenic Diet (LCKD)
Behavioral: Low Fat Diet (LFD)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Diet, Imaging and Energy Balance Trial

Resource links provided by NLM:


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 ]

Enrollment: 51
Study Start Date: August 2008
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low Carbohydrate Ketogenic Diet (LCKD)
participants will follow a low carbohydrate ketogenic diet for six weeks
Behavioral: Low Carbohydrate Ketogenic Diet (LCKD)
participants will follow a low carbohydrate ketogenic diet for six weeks
Experimental: Low Fat Diet (LFD)
particpants will follow a low fat diet for six weeks
Behavioral: Low Fat Diet (LFD)
particpants will follow a low fat diet for six weeks

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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00787280

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
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
ClinicalTrials.gov Identifier: NCT00787280     History of Changes
Other Study ID Numbers: Pro00002610
Study First Received: November 6, 2008
Last Updated: February 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
obese
overweight
fMRI
Diet

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

ClinicalTrials.gov processed this record on July 29, 2014