Pilot Study of Dietary Modification of Appetite Set Point in Obesity

Stopped early · Not applicable

Conditions studied: Obesity

In brief

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

Key facts

Study ID: NCT00726271
Run by: State University of New York - Upstate Medical University
People needed: 50
Starts: 2008-06-01
Expected to finish: 2008-09-01
Last updated by the study team: 2021-04-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Must be taking at least one medication that is described in the Lexi-comp data base used by SUNY Upstate Medical University Hospital for drug information, as potentially causing weight gain
BMI must be over 29
Must be fluent in English
Must have access to a telephone
Must be able and willing to come in for weekly measurements during the six weeks
Must not be known to be currently hypothyroid or hyperthyroid. Someone who is euthyroid on replacement could be eligible

You may not qualify if…

Inability to fully understand the protocol and consent form, including people who have active psychosis
Type 1 Diabetes
Inability to read at the 4th grade level
Current alcohol abuse as determined by the primary provider, or illicit substance use
Current warfarin use
Bleeding disorder or thrombocytopenia
Allergy to fish oil, flaxseed oil, or olive oil
Current use of any medication that has a probable negative interaction with any of the oils used in the intervention

Where it is running

SUNY Upstate Medical University — Syracuse, New York, United States

Full record on ClinicalTrials.gov

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