Pilot Study of Dietary Modification of Appetite Set Point in Obesity
NCT00726271 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2021-04-22
Summary
An innovative dietary approach to obesity, based on the set-point theory of body weight and associative learning, was developed by Seth Roberts. Roberts's approach focuses on dissociating flavor and calories by consuming small amounts of very bland but calorie-dense foods such as extra-light olive oil between meals. Roberts believes that the dissociation between flavor and calories lowers the body weight's set point, suppressing appetite and thereby inducing weight loss without causing hunger. Studying the feasibility of this approach is particularly relevant to patients taking drugs that cause increased appetite and weight gain as a side effect, as increased hunger makes the usual calorie restriction approach even more difficult than it normally is. Low-income people have a diet higher in prepackaged standardized foods, which may be one contributing factor to their higher risk of developing obesity.
Specific Aims
* To test the acceptance of, and the patients' compliance rate to, the Shangri-La Diet
* To ascertain whether a controlled clinical trial of the Shangri-La Diet would be feasible.
* To see if the weight loss documented anecdotally in many people is reproducible in patients from low-income areas who are overweight and taking prescribed medications associated with increased appetite and weight gain.
Analysis: The primary end point will be acceptability of the dietary intervention as measured by the final interview and the evaluation form-is this something patients would be willing to do over the long term? This will help determine whether a controlled trial of the dietary intervention would be feasible, and provide information needed to design such a trial. Secondary outcomes will be changes in the participants' weight, waist measurements, anxiety, and depression scores
Conditions
Interventions
- DIETARY_SUPPLEMENT
-
light olive oil, fish oil capsules, flax seed oil capsules
fish oil 1000 mg capsules three daily flax seed oil 1000 mg capsules three daily light olive oil 30 ml to 60 ml daily(weight less than 160 pounds, 30 ml/ weight 160-200 pounds 45 ml/ weight over 200 pounds 60 ml)
Sponsors & Collaborators
-
State University of New York - Upstate Medical University
lead OTHER
Principal Investigators
-
Lisa Kaufmann, MD · State University of New York - Upstate Medical University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-06-30
- Primary Completion
- 2008-09-30
- Completion
- 2008-09-30
Countries
- United States
Study Locations
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