CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 100 enrolled
Drug / intervention
PhosphoLean +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01976156
NCT01976156N/ACompleted
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The Gut-brain Axis: a Novel Target for Treating Behavioral Alterations in Obesity

Yale University·interventional·Posted Nov 5, 2013·Updated Jun 27, 2018

In Brief

A clinical study evaluating PhosphoLean and Placebo for Neural Response in Caudate and 2 related conditions. Completed, enrolled 100 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeural Response in Caudate, Weight Loss Trial, Impulsivity
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 5, 2013
Enrollment StartOct 1, 2013
Primary CompletionOct 1, 2017
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 12.7 years ago

Interventions

PhosphoLeandietary

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).

Placebodietary

Placebo consists of rice flour