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The Gut-brain Axis in Food Reward and Alcohol Consumption

NCT01902069 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2020-04-03

No results posted yet for this study

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. Evaluate whether supplementation with NOPE-EGCG versus placebo results in reductions in alcohol consumption.
3. 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.

Conditions

  • Impulsivity
  • Alcohol Consumption

Interventions

DIETARY_SUPPLEMENT

Phospholean

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).

DIETARY_SUPPLEMENT

Placebo

Placebo consists of rice flour

Sponsors & Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    collaborator NIH

  • Yale University

    lead OTHER

Principal Investigators

  • Dana M Small, PhD · The John B. Pierce Laboratory

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2014-11-30
Completion
2014-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01902069 on ClinicalTrials.gov