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Sponsors and Collaborators: |
Duke University Robert C. Atkins Foundation |
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Information provided by: | Duke University |
ClinicalTrials.gov Identifier: | NCT00787280 |
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 |
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Obesity |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Diet, Imaging and Energy Balance Trial |
We will take a blood sample to analyze for DNA
Estimated Enrollment: | 60 |
Study Start Date: | August 2008 |
Groups/Cohorts |
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A
Low Carbohydrate
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B
Low Calorie/Low Fat
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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.
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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.
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:
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 |
Principal Investigator: | Francis J McClernon, Ph.D | Duke University |
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 |
obese overweight fMRI Diet |
Body Weight Signs and Symptoms Obesity |
Nutrition Disorders Overnutrition Overweight |
Body Weight Signs and Symptoms Obesity |
Nutrition Disorders Overweight Overnutrition |