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.
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
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
- 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.
- 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 group | Role | What they receive |
|---|---|---|
| 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. 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.
acceptability and adherence to the dietary intervention
Measured: 6 weeks
Secondary outcomes (3)
weight
Measured: 6 weeks
waist circumference
Measured: 6 weeks
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.
- First posted31 Jul 2008 (estimated)
- Study startJun 2008
- Primary completionSep 2008
- Study completionSep 2008
Why it stopped: Record owner left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Investigators
- Lisa Kaufmann, MD, Principal investigator, State University of New York - Upstate Medical University
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00726271
- Acronym / sponsor ID
- 5653
- Conditions
- Obesity
- Keywords
- obesity, appetite set point
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Record owner left institution
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 31 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| active | Experimental | Dietary Supplement: light olive oil, fish oil capsules, flax seed oil capsulesSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| light olive oil, fish oil capsules, flax seed oil capsulesAlso: Naturemade brand flax seed and fish oils, Wegman's store brand light olive oilfish 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) | Dietary supplement | active |
Primary outcome
acceptability and adherence to the dietary intervention
Time frame: 6 weeks
3 secondary outcomes
weight
Time frame: 6 weeks
waist circumference
Time frame: 6 weeks
body mass index
Time frame: 6 weeks
Results and safety
The study was stopped early (reason given: Record owner left institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Kaufmann, MD principal investigator
State University of New York - Upstate Medical University
1 site in 1 country: see every site and its status.
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.