Oatmeal Effect on N-acyl-phosphatidylethanolamines

NCT03468179 | Completed Results

• 1 other identifier: JJWPending
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

N-acyl-phosphatidylethanolamine (NAPEs) and their active metabolites, N-acyl-ethanolamides (NAEs) are lipid satiety factors that are normally biosynthesized in the intestinal tract in response to food intake. Reduced levels of NAPEs and NAEs have been found in obese individuals, and increasing plasma NAPE and NAEs levels may be beneficial to obese individuals trying to lose weight or to keep off weight gain after losing weight. We have found that oatmeal has large amounts of NAPEs, and based on previous mouse studies, we hypothesize that a single dose of dietary oatmeal is sufficient to double plasma NAE from baseline, possibly inducing satiety and increasing basal metabolic rate. To test this hypothesis, we will feed volunteers a single weight-based serving of oatmeal while monitoring its effects on serum glucose, NAPE and NAE levels as well as on subjective satiety.

Conditions

Obesity; Cardiovascular Diseases

Keywords

Diet; N-acyl-phosphatidylethanolamine; N-acyl-ethanolamine; NAPE; NAE; Oatmeal

Outcome Measures

Primary Outcomes (1)

• Change in Serum N-acyl-phosphatidylethanolamine (NAPE)

  Change in serum NAPE from baseline to 120 minutes post-oatmeal challenge

  Baseline to 120 minutes

Secondary Outcomes (2)

• Serum NAPE

  30, 60, and 90 minutes

• Serum N-acyl-ethanolamides (NAE)

  baseline 30, 60, 90 and 120 minutes

Study Arms (1)

Oatmeal

EXPERIMENTAL

Subjects will arrive for study fasting. IV access will be obtained, and baseline blood drawn. They will be fed 80gm/100kg oatmeal, and blood levels will be drawn at 30, 60, 90, and 120 minutes.

Dietary Supplement: Oatmeal

Interventions

Oatmeal DIETARY_SUPPLEMENT

Subjects will be fed a calculated serving of oatmeal.

Oatmeal

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: 5 Male, 5 female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult
• non-pregnant
• normal BMI (20-25)

You may not qualify if:

• Obese
• underweight
• diabetes mellitus
• coronary artery disease
• oatmeal allergies
• hyper/hypocoagulability
• food intolerances
• Irritable bowel syndrome
• Inflammatory bowel disease
• Celiac disease
• pregnancy

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Obesity; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Limitation of this study was that only 1 dose of oatmeal was used and the study group was relatively small.

Results Point of Contact

• Title: Sean S. Davies
• Organization: Vanderbilt University

sean.davies@vanderbilt.edu

6153225049

Study Officials

• Sean Davies, PhD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: All subjects will have baseline blood drawn, fed controlled serving of oatmeal, and blood drawn sequentially over subsequent 2 hours.

Study Record Dates

• First Submitted: March 9, 2018
• First Posted: March 16, 2018
• Study Start: October 7, 2018
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: December 13, 2019
• Results First Posted: December 13, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)