The Gut-brain Axis in Food Reward and Alcohol Consumption

NCT01902069 | Completed DMC

• 2 other identifiers: 13050121065P50AA012870
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

The aims of this project are to:

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

Keywords

sweet and fat preference

Outcome Measures

Primary Outcomes (3)

• Fat and sweet preference

  Subject will be asked to sample and rate fatty and sweet flavor stimuli (all made from commercially available ingredients).

  21 days

• Impulsivity

  Various questionnaires and computer tasks addressing impulsivity.

  21 days

• Alcohol consumption

  Interview addressing alcohol consumption

  21 days

Study Arms (2)

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.

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.

Dietary Supplement: Placebo

Interventions

Phospholean DIETARY_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).

Phosholean dietary supplement

Placebo DIETARY_SUPPLEMENT

Placebo consists of rice flour

Placebo (rice flour) group

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

John B Pierce Laboratory

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Impulsive Behavior; Alcohol Drinking

Condition Hierarchy (Ancestors)

Behavior; Drinking Behavior

Study Officials

• Dana M Small, PhD

  The John B. Pierce Laboratory

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2013
• First Posted: July 17, 2013
• Study Start: July 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: April 3, 2020

Record last verified: 2020-04

Locations

US (1)