- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00787280
Diet, Imaging and Energy Balance Trial (DIET) (DIET)
February 18, 2013 updated by: Duke University
Diet, Imaging and Energy Balance Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
51
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
-
Durham, North Carolina, United States, 27705
- Duke University Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Low Carbohydrate Ketogenic Diet (LCKD)
participants will follow a low carbohydrate ketogenic diet for six weeks
|
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
|
particpants will follow a low fat diet for six weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2008
Primary Completion (ACTUAL)
November 1, 2010
Study Completion (ACTUAL)
November 1, 2010
Study Registration Dates
First Submitted
November 6, 2008
First Submitted That Met QC Criteria
November 6, 2008
First Posted (ESTIMATE)
November 7, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
February 20, 2013
Last Update Submitted That Met QC Criteria
February 18, 2013
Last Verified
February 1, 2013
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Pro00002610
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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