ImpulsivityNCT01902069
The Gut-brain Axis in Food Reward and Alcohol Consumption
A study testing Phospholean in people with Impulsivity and Alcohol Consumption, run by Yale University at 1 site in United States.
Trial summary
The aims of this project are to: 1. Determine if 3-weeks dietary supplementation with NOPE-EGCG (PhosphoLEANtm, 85mg NOPE+50mg EGCG per capsule) versus a placebo will improve performance on impulsivity, go/no-go tasks and negative outcome learning in heavy drinkers. 2. Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Impulsivity, Alcohol Consumption
- What is being tested?
- Phospholean
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Nov 2014
- 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 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects meeting NIAAA heavy drinking criteria (for men defined as consuming 5 or more standard drinks on a drinking day and for women as consuming 4 or more standard drinks on a drinking day at least once per week for the prior 30 days, with an upper limit of 40 standard drinks per week). Half will be women. Right handed, English speaking, be a non-smoker (never smoked more than 2 cigarettes per month). Subjects will have a BMI between 18.5 and 35.
Who cannot join
- a) serious or unstable medical illness (e.g., cancer); b) past or current history of alcoholism or consistent drug use; c) current major psychiatric illness as defined by the DSM-IV criteria including eating disorders d) medications that affect alertness (e.g., barbiturates, benzodiazepines, chloral hydrate, haloperidol, lithium, carbamazepine, phenytoin, etc.); e) history of major head trauma with loss of consciousness; f) ongoing pregnancy; g) known taste or smell dysfunction; h) a diagnosis of diabetes; i) any known food allergy, certain food sensitivities (lactose); j) pregnant or nursing women. Daily drinkers and individuals meeting criteria for alcohol dependence will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
John B Pierce Laboratory
New Haven, Connecticut, 06519
About this study
The aims of this project are to:
- Determine if 3-weeks dietary supplementation with NOPE-EGCG (PhosphoLEANtm, 85mg NOPE+50mg EGCG per capsule) versus a placebo will improve performance on impulsivity, go/no-go tasks and negative outcome learning in heavy drinkers.
- Evaluate whether supplementation with NOPE-EGCG versus placebo results in reductions in alcohol consumption.
- Preliminary data in the rodent model suggests that rats treated with OEA shift preference for lower fat test stimuli. In aim 3 we will Determine if 3-weeks of supplementation with PhosphoLEAN shifts fat preference towards lower fat test puddings.
Read the detailed description
Similarities in striatocortical pathway dysfunction have been noted for alcoholism and obesity. In prior studies we have demonstrated an inverse relationship between body mass index and response in the dorsal striatum (DS) during consumption of a palatable milkshake[1]. We have also shown that the magnitude of the reduced response predicts weight gain, especially in individuals who carry a copy of the A1 allele of the taq1A polymorphism[1]. Since the A1 allele is associated with reduced striatal D2 receptors [2-7], this finding implicates the dopamine system in the reduced blood oxygen level dependent (BOLD) response. Our results also indicate that this reduced response is a consequence, rather than a cause of obesity, since gaining weight [8], but not risk for obesity [9] (by virtue of parental obesity), is associated with reduced DS response to palatable food. Taken together the results indicate that increased adiposity is associated with blunted DS response to palatable food that may reflect altered dopamine signaling. More recently we determined that reduced DS responses in overweight and obese subjects are associated with increased impulsivity measured with the BIS-11 and a go no/no-go task [10]. Heavy drinkers are also more likely to be impulsive [11]. In preliminary analyses of data on over 300 individuals assessed with the clinical core battery in the Center for the Translational Neuroscience of Alcoholism (CTNA), we found that higher scores on the BIS-11 and other measures of impulsivity were associated with greater alcohol consumption.
Related to these findings in humans, preliminary work in rodents shows that exogenous administration of N-Acylethanolamines, such as oleoylethanolamine (OEA) can normalize high-fat diet induced dopamine decreases in DS. Human testing of OEA supplementation is possible based on the availability of a dietary supplement containing the OEA precursor NOPE-EGCG ((PhosphoLEANtm, 85mg NOPE+50mg EGCG per capsule). PhosphoLEAN has been shown to enhance adherence to dietary advice in overweight healthy subjects [12-14]. We therefore propose a pilot study to test whether PhosphoLEAN will improve performance on impulsivity, go/no-go tasks and negative outcome learning. Specifically, we will recruit heavy drinkers because they are more likely to be impulsive [11]. Phospholean may improve negative reinforcement learning in this population. This may lead to reductions in drinking as well. We will also explore whether the supplement leads to reductions in alcohol consumption and preference for high fat foods.
- Conditions
- Impulsivity, Alcohol Consumption
- Being tested
- Phospholean, Placebo
- Keywords
- sweet and fat preference
- Medical subject headings
- Impulsive Behavior, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhospholeanDietary supplement
Phospholean supplied by Cheminutra (White Bear Lake, MN). PhosphoLean® N-Oleoyl-PE + EGCG (NOPE + EGCG) is a proprietary phosphobioflavonic complex of N-oleoyl-phosphatidyl-ethanolamine (NOPE), which contains oleoyl ethanolamine (OEA) bound to phosphatidylethanolamine (PE), and epigallocatechin gallate (EGCG).
PhosphoLean® 40P is a dietary ingredient under the Dietary Supplement Health and Education Act (DSHEA) regulations of the US FDA (1994).
PlaceboDietary supplement
Placebo consists of rice flour
| Study group | Role | What they receive |
|---|---|---|
| Phosholean dietary supplement | Experimental | Subjects in the PhosphoLean group will receive two capsules of PhosphoLEAN orally daily (total of 55 mg of NOPE and 100 mg of EGCG), one capsule consumed 60 minutes prior to lunch and one capsule 60 minutes prior to dinner. Receives: Dietary Supplement: Phospholean |
| Placebo (rice flour) group | Placebo comparator | The control (placebo) group will receive a placebo (identical in appearance, but containing 100 mg of rice flour per capsule), one capsule consumed 60 minutes prior to lunch and one capsule 60 minutes prior to dinner. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat and sweet preference
Subject will be asked to sample and rate fatty and sweet flavor stimuli (all made from commercially available ingredients).
Measured: 21 days
Impulsivity
Various questionnaires and computer tasks addressing impulsivity.
Measured: 21 days
Alcohol consumption
Interview addressing alcohol consumption
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImpulsivityStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Dana M Small, PhD, Principal investigator, The John B. Pierce Laboratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01902069
- Sponsor's protocol ID
- 1305012106
- Other IDs
- 5P50AA012870
- Status last verified
- Apr 2020
- First submitted
- 15 Jul 2013
- Last updated
- 3 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Gut-brain Axis in Food Reward and Alcohol Consumption
- ClinicalTrials.gov ID
- NCT01902069
- Acronym / sponsor ID
- 1305012106
- Conditions
- Impulsivity, Alcohol Consumption
- Keywords
- sweet and fat preference
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Jul 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 17 Jul 2013 (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.
The aims of this project are to:
- Determine if 3-weeks dietary supplementation with NOPE-EGCG (PhosphoLEANtm, 85mg NOPE+50mg EGCG per capsule) versus a placebo will improve performance on impulsivity, go/no-go tasks and negative outcome learning in heavy drinkers.
- Evaluate whether supplementation with NOPE-EGCG versus placebo results in reductions in alcohol consumption.
- Preliminary data in the rodent model suggests that rats treated with OEA shift preference for lower fat test stimuli. In aim 3 we will Determine if 3-weeks of supplementation with PhosphoLEAN shifts fat preference towards lower fat test puddings.
Detailed description
Similarities in striatocortical pathway dysfunction have been noted for alcoholism and obesity. In prior studies we have demonstrated an inverse relationship between body mass index and response in the dorsal striatum (DS) during consumption of a palatable milkshake[1]. We have also shown that the magnitude of the reduced response predicts weight gain, especially in individuals who carry a copy of the A1 allele of the taq1A polymorphism[1]. Since the A1 allele is associated with reduced striatal D2 receptors [2-7], this finding implicates the dopamine system in the reduced blood oxygen level dependent (BOLD) response. Our results also indicate that this reduced response is a consequence, rather than a cause of obesity, since gaining weight [8], but not risk for obesity [9] (by virtue of parental obesity), is associated with reduced DS response to palatable food. Taken together the results indicate that increased adiposity is associated with blunted DS response to palatable food that may reflect altered dopamine signaling. More recently we determined that reduced DS responses in overweight and obese subjects are associated with increased impulsivity measured with the BIS-11 and a go no/no-go task [10]. Heavy drinkers are also more likely to be impulsive [11]. In preliminary analyses of data on over 300 individuals assessed with the clinical core battery in the Center for the Translational Neuroscience of Alcoholism (CTNA), we found that higher scores on the BIS-11 and other measures of impulsivity were associated with greater alcohol consumption.
Related to these findings in humans, preliminary work in rodents shows that exogenous administration of N-Acylethanolamines, such as oleoylethanolamine (OEA) can normalize high-fat diet induced dopamine decreases in DS. Human testing of OEA supplementation is possible based on the availability of a dietary supplement containing the OEA precursor NOPE-EGCG ((PhosphoLEANtm, 85mg NOPE+50mg EGCG per capsule). PhosphoLEAN has been shown to enhance adherence to dietary advice in overweight healthy subjects [12-14]. We therefore propose a pilot study to test whether PhosphoLEAN will improve performance on impulsivity, go/no-go tasks and negative outcome learning. Specifically, we will recruit heavy drinkers because they are more likely to be impulsive [11]. Phospholean may improve negative reinforcement learning in this population. This may lead to reductions in drinking as well. We will also explore whether the supplement leads to reductions in alcohol consumption and preference for high fat foods.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phosholean dietary supplement | Experimental | Dietary Supplement: PhospholeanSubjects in the PhosphoLean group will receive two capsules of PhosphoLEAN orally daily (total of 55 mg of NOPE and 100 mg of EGCG), one capsule consumed 60 minutes prior to lunch and one capsule 60 minutes prior to dinner. |
| Placebo (rice flour) group | Placebo comparator | Dietary Supplement: PlaceboThe control (placebo) group will receive a placebo (identical in appearance, but containing 100 mg of rice flour per capsule), one capsule consumed 60 minutes prior to lunch and one capsule 60 minutes prior to dinner. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Subjects meeting NIAAA heavy drinking criteria (for men defined as consuming 5 or more standard drinks on a drinking day and for women as consuming 4 or more standard drinks on a drinking day at least once per week for the prior 30 days, with an upper limit of 40 standard drinks per week). Half will be women. Right handed, English speaking, be a non-smoker (never smoked more than 2 cigarettes per month). Subjects will have a BMI between 18.5 and 35.
Key exclusion criteria (1 listed)
- a) serious or unstable medical illness (e.g., cancer); b) past or current history of alcoholism or consistent drug use; c) current major psychiatric illness as defined by the DSM-IV criteria including eating disorders d) medications that affect alertness (e.g., barbiturates, benzodiazepines, chloral hydrate, haloperidol, lithium, carbamazepine, phenytoin, etc.); e) history of major head trauma with loss of consciousness; f) ongoing pregnancy; g) known taste or smell dysfunction; h) a diagnosis of diabetes; i) any known food allergy, certain food sensitivities (lactose); j) pregnant or nursing women. Daily drinkers and individuals meeting criteria for alcohol dependence will be excluded.
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 |
|---|---|---|
| PhospholeanPhospholean supplied by Cheminutra (White Bear Lake, MN). PhosphoLean® N-Oleoyl-PE + EGCG (NOPE + EGCG) is a proprietary phosphobioflavonic complex of N-oleoyl-phosphatidyl-ethanolamine (NOPE), which contains oleoyl ethanolamine (OEA) bound to phosphatidylethanolamine (PE), and epigallocatechin gallate (EGCG). PhosphoLean® 40P is a dietary ingredient under the Dietary Supplement Health and Education Act (DSHEA) regulations of the US FDA (1994). | Dietary supplement | Phosholean dietary supplement |
| PlaceboPlacebo consists of rice flour | Dietary supplement | Placebo (rice flour) group |
Primary outcome
Fat and sweet preference
Time frame: 21 days
Subject will be asked to sample and rate fatty and sweet flavor stimuli (all made from commercially available ingredients).
Impulsivity
Time frame: 21 days
Various questionnaires and computer tasks addressing impulsivity.
Alcohol consumption
Time frame: 21 days
Interview addressing alcohol consumption
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2020.
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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.
Dana M Small, PhD principal investigator
The John B. Pierce Laboratory
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phospholean in people with Impulsivity and Alcohol Consumption, run by Yale 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 3 Apr 2020. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Fat and sweet preference (time frame: 21 days). The study lists 3 primary outcomes in all. 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 3 Apr 2020; AzTrials last refreshed its copy on 7 Nov 2026.