AzTrials
AzTrials

ObesityNCT00726271

Pilot Study of Dietary Modification of Appetite Set Point in Obesity

A study testing light olive oil, fish oil capsules, flax seed oil capsules in people with Obesity, run by State University of New York - Upstate Medical University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity
What is being tested?
light olive oil, fish oil capsules, flax seed oil capsules
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
Jun 2008to Sep 2008
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • SUNY Upstate Medical University

    Syracuse, New York, 13210

Other trials in United States

About this study

Official title: A Pilot 6 Week Study of the Feasibility and Acceptability of Dietary Modification With the Goal of Changing the Appetite Set Point in People Taking Medications That Cause Weight Gain Through Increased Appetite.

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

Read more
  • 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

Read the detailed description

An innovative dietary approach to obesity, based on the set-point theory of body weight and associative learning, was developed by Seth Roberts, professor of psychology at the University of California at Berkeley. The set-point theory was first proposed by G. Kennedy, who hypothesized that body fat, like body temperature, is controlled by a set point in a thermostat-like system. Based on this theory and subsequent work, Roberts hypothesized that people have a strong conditioned response to specific food items, which raises the weight set point, like a thermostat, stimulating appetite and storing the excess calories as fat. In an environment with attractive, easily accessible, inexpensive food, many people will gain weight. Roberts also hypothesizes that consistency in the presentation, labeling, and taste of mass produced food items today elicits a stronger conditioned response than in the past. 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 or sugar water 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. Decreased oral intake naturally follows a decrease in appetite, without the hunger that normally quickly appears when people reduce their caloric intake, so people can eat an amount that feels comfortable without conscious dietary restriction. Roberts outlined this approach in a book titled "The Shangri-La Diet" because it is not really a diet at all. Given the originality of this approach, the successful outcomes accounted in the book and in anecdotes on the internet definitely warrant a closer look. Studying the feasibility of the Shangri-La Diet 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.

Methods

  1. 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 (HDL, LDL, and triglycerides) and ranges associated with a decreased risk of cardiac and all cause mortality in epidemiological studies. They will return weekly for measurement of weight, waist measurements, discussion of any problems with the oils, and dose adjustment of the oils.
  2. Evaluation: At the end of 6 weeks of the intervention, the subjects will complete the same questionnaires as at baseline, and an evaluation form about the intervention.

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? Secondary outcomes will be changes in the participants' weight, waist measurements, anxiety, and depression scores.

Conditions
Obesity
Being tested
light olive oil, fish oil capsules, flax seed oil capsules
Keywords
obesity, appetite set point
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • light olive oil, fish oil capsules, flax seed oil capsulesDietary supplement

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

    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)

Study groups in NCT00726271
Study groupRoleWhat they receive
activeExperimentalSubjects 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.
Receives: Dietary Supplement: light olive oil, fish oil capsules, flax seed oil capsules

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. acceptability and adherence to the dietary intervention

    Measured: 6 weeks

Secondary outcomes (3)
  1. weight

    Measured: 6 weeks

  2. waist circumference

    Measured: 6 weeks

  3. body mass index

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2008 (estimated)
  2. Study startJun 2008
  3. Primary completionSep 2008
  4. Study completionSep 2008

Why it stopped: Record owner left institution

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00726271
Sponsor's protocol ID
5653
Status last verified
Apr 2021
First submitted
28 Jul 2008
Last updated
22 Apr 2021
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing light olive oil, fish oil capsules, flax seed oil capsules in people with Obesity, run by State University of New York - Upstate Medical 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 6 inclusion and 8 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: stopped early, as of the sponsor's last update on 22 Apr 2021. 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 was stopped early (reason given: Record owner left institution). Results are not available in the source record.

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?

acceptability and adherence to the dietary intervention (time frame: 6 weeks). 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 22 Apr 2021.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in