NCT04849962

Brief Summary

Pecans are a nutrient-dense food, but it is unknown whether substituting pecans for a portion of the butter in a traditional breakfast meal improves post-meal responses.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 10, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2018

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

April 7, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 20, 2021

Completed
Last Updated

April 20, 2021

Status Verified

April 1, 2021

Enrollment Period

7 months

First QC Date

April 7, 2021

Last Update Submit

April 13, 2021

Conditions

Outcome Measures

Primary Outcomes (4)

  • Change in triglycerides (TG) and glucose

    TG (mg/dL) and glucose (mg/dL)

    Change from baseline to 3 hours postprandially

  • Change in lipid peroxidation

    Malondialdehyde (MDA) (uM) measured via Thiobarbituric acid reactive substances (TBARS) assay

    Change from baseline to 3 hours postprandially

  • Change in total antioxidant capacity

    Total antioxidant capacity (uM trolox equivalents) measured via Oxygen Radical Absorbance Capacity (ORAC) assay.

    Change from baseline to 3 hours postprandially

  • Change in insulin

    Insulin (uU/mL)

    Change from baseline to 3 hours postprandially

Secondary Outcomes (2)

  • Change in angiopoietin-like proteins-3 (ANGPTL3) and -4 (ANGPTL4) responses

    Change from baseline to 3 hours postprandially

  • Change in hunger and satiety responses

    Change from baseline to 3 hours postprandially

Study Arms (2)

Control

ACTIVE COMPARATOR

Participants in this group received a traditional muffin with butter as the predominant source of fat.

Other: Control

Pecan

EXPERIMENTAL

Participants in this group received a muffin in which part of the butter was substituted out for pecans.

Other: Pecan

Interventions

ControlOTHER

Participants in this group received a traditional muffin with butter as the predominant source of fat.

Control
PecanOTHER

Participants in this group received a muffin in which part of the butter was substituted out for pecans.

Pecan

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adult men and women
  • Normal-weight (body mass index = 18-24.9kg/m2)

You may not qualify if:

  • Allergies to test meal ingredients (gluten, eggs, or nuts)
  • Medication/supplement usage
  • Chronic disease
  • Pregnancy or plans to become pregnant
  • Special diets
  • Tobacco use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Georgia - Department of Foods and Nutrition & Department of Food Science and Technology

Athens, Georgia, 30602, United States

Location

Study Officials

  • Chad M Paton, PhD

    University of Georgia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Director of UGA Obesity Initiative

Study Record Dates

First Submitted

April 7, 2021

First Posted

April 20, 2021

Study Start

August 10, 2017

Primary Completion

February 27, 2018

Study Completion

February 27, 2018

Last Updated

April 20, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations