Pilot Study of Dietary Modification of Appetite Set Point in Obesity

NCT00726271 | Terminated

• 1 other identifier: 5653
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Obesity

Keywords

obesity; appetite set point

Outcome Measures

Primary Outcomes (1)

• acceptability and adherence to the dietary intervention

  6 weeks

Secondary Outcomes (3)

• weight

  6 weeks

• waist circumference

  6 weeks

• body mass index

  6 weeks

Study Arms (1)

active

EXPERIMENTAL

Subjects will complete the Zung Depression and Anxiety Scales. At the first visit the subject's medication list, weight, height, and waist measurement will be obtained. The goal is to recruit a minimum of 20 patients. Subjects will receive light olive oil, and capsules of fish oil and flaxseed oil, to take daily at home with weight based dosing, based on the doses recommended in Dr. Roberts' work. Doses are within the recommended dietary ranges to improve intermediate outcomes for coronary artery disease subjects. They will return weekly for measurement of weight, waist measurements, discussion of any problems with the oils, and dose adjustment of the oils.

Dietary Supplement: light olive oil, fish oil capsules, flax seed oil capsules

Interventions

light olive oil, fish oil capsules, flax seed oil capsules DIETARY_SUPPLEMENT

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)

Also known as: Naturemade brand flax seed and fish oils, Wegman's store brand light olive oil

active

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• State University of New York - Upstate Medical University: lead

Study Sites (1)

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Linseed Oil; Fish Oils

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fats, Unsaturated; Fats; Lipids; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Lisa Kaufmann, MD

  State University of New York - Upstate Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 28, 2008
• First Posted: July 31, 2008
• Study Start: June 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: April 22, 2021

Record last verified: 2021-04

Locations

US (1)