ObesityDIETNCT00787280
Diet, Imaging and Energy Balance Trial (DIET)
A study testing Low Carbohydrate Ketogenic Diet (LCKD) and Low Fat Diet (LFD) in people with Obesity, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Low Carbohydrate Ketogenic Diet (LCKD) and Low Fat Diet (LFD)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Nov 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 24Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27705
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Low Carbohydrate Ketogenic Diet (LCKD), Low Fat Diet (LFD)
- Keywords
- obese, overweight, fMRI, Diet
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Carbohydrate Ketogenic Diet (LCKD)Behavioural
participants will follow a low carbohydrate ketogenic diet for six weeks
Low Fat Diet (LFD)Behavioural
particpants will follow a low fat diet for six weeks
| Study group | Role | What they receive |
|---|---|---|
| Low Carbohydrate Ketogenic Diet (LCKD) | Experimental | participants will follow a low carbohydrate ketogenic diet for six weeks Receives: Behavioral: Low Carbohydrate Ketogenic Diet (LCKD) |
| Low Fat Diet (LFD) | Experimental | particpants will follow a low fat diet for six weeks Receives: Behavioral: Low Fat Diet (LFD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compared to individuals in the LFD group, individuals placed on an LCKD will exhibit decreased brain responses to high-carbohydrate food cues.
Measured: 1 month
Secondary outcomes (1)
In addition to these questions, we will also examine relations between food consumption acquired from the diaries, genetic factors and brain function.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2008 (estimated)
- Study startAug 2008
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Robert C. Atkins Foundation
- Responsible party
- Sponsor
- Investigators
- Francis J McClernon, Ph.D, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00787280
- Sponsor's protocol ID
- Pro00002610
- Acronym
- DIET
- Status last verified
- Feb 2013
- First submitted
- 6 Nov 2008
- Last updated
- 20 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet, Imaging and Energy Balance Trial
- ClinicalTrials.gov ID
- NCT00787280
- Acronym / sponsor ID
- DIET / Pro00002610
- Conditions
- Obesity
- Keywords
- obese, overweight, fMRI, Diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Robert C. Atkins Foundation
- Study start
- Aug 2008
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 7 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Carbohydrate Ketogenic Diet (LCKD) | Experimental | Behavioral: Low Carbohydrate Ketogenic Diet (LCKD)participants will follow a low carbohydrate ketogenic diet for six weeks |
| Low Fat Diet (LFD) | Experimental | Behavioral: Low Fat Diet (LFD)particpants will follow a low fat diet for six weeks |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Carbohydrate Ketogenic Diet (LCKD)participants will follow a low carbohydrate ketogenic diet for six weeks | Behavioural | Low Carbohydrate Ketogenic Diet (LCKD) |
| Low Fat Diet (LFD)particpants will follow a low fat diet for six weeks | Behavioural | Low Fat Diet (LFD) |
Primary outcome
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 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francis J McClernon, Ph.D principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Carbohydrate Ketogenic Diet (LCKD) and Low Fat Diet (LFD) in people with Obesity, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2013.