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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
51

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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:

  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

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duke University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Robert C. Atkins Foundation

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2008

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2010

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 6, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2008

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 7, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 20, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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