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The Gut-brain Axis: a Novel Target for Treating Behavioral Alterations in Obesity

NCT01976156 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2018-06-27

No results posted yet for this study

Summary

The aims of this project are to determine if dietary supplementation with NOPE-EGCG (PhosphoLeantm, 30mg NOPE+20mg EGCG per capsule) can:

* rescue striatal function,
* increase adherence to a diet,
* reduce weight-gain after a diet,
* improve performance on impulsivity, go/no-go tasks, and negative outcome learning, and
* shift fat and sweet preference in overweight/obese human subjects

Secondary hypotheses: Baseline brain; perceptual and cognitive measures will be associated with diet, insulin sensitivity and may vary with genotype (TaqA1 1A polymorphism).

Conditions

  • Neural Response in Caudate
  • Weight Loss Trial
  • Impulsivity

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).

DIETARY_SUPPLEMENT

Placebo

Placebo consists of rice flour

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    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
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2017-10-31
Completion
2017-10-31

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 NCT01976156 on ClinicalTrials.gov