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The Gut-brain Axis in Food Reward and Alcohol Consumption

Primary Purpose

Impulsivity, Alcohol Consumption

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Phospholean
Placebo
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Impulsivity focused on measuring sweet and fat preference

Eligibility Criteria

21 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • John B Pierce Laboratory

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Phosholean dietary supplement

Placebo (rice flour) group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Fat and sweet preference
Subject will be asked to sample and rate fatty and sweet flavor stimuli (all made from commercially available ingredients).
Impulsivity
Various questionnaires and computer tasks addressing impulsivity.
Alcohol consumption
Interview addressing alcohol consumption

Secondary Outcome Measures

Full Information

First Posted
July 15, 2013
Last Updated
April 1, 2020
Sponsor
Yale University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT01902069
Brief Title
The Gut-brain Axis in Food Reward and Alcohol Consumption
Official Title
The Gut-brain Axis in Food Reward and Alcohol Consumption
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impulsivity, Alcohol Consumption
Keywords
sweet and fat preference

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phosholean dietary supplement
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo (rice flour) group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Phospholean
Intervention Description
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).
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo consists of rice flour
Primary Outcome Measure Information:
Title
Fat and sweet preference
Description
Subject will be asked to sample and rate fatty and sweet flavor stimuli (all made from commercially available ingredients).
Time Frame
21 days
Title
Impulsivity
Description
Various questionnaires and computer tasks addressing impulsivity.
Time Frame
21 days
Title
Alcohol consumption
Description
Interview addressing alcohol consumption
Time Frame
21 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dana M Small, PhD
Organizational Affiliation
The John B. Pierce Laboratory
Official's Role
Principal Investigator
Facility Information:
Facility Name
John B Pierce Laboratory
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States

12. IPD Sharing Statement

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The Gut-brain Axis in Food Reward and Alcohol Consumption

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