Acute Consumption of Pecan-enriched Meal

Sponsor

University of Georgia (Other)

Overall Status

Completed

CT.gov ID

NCT04849962

Collaborator

(none)

Enrollment

Location

Arms

6.6

Actual Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Other: Control Other: Pecan	N/A

Detailed Description

This study was a randomized, double-blind control trial consisting of 2 study visits for 2 different treatments. The treatments were high-fat breakfast muffins containing either butter (control) or pecans. The investigators recruited healthy, normal-weight adults between the ages of 15 and 45y. Study visits were completed in a random order with at least 72 hours between each visit. Anthropometrics, questionnaires, and fasting and postprandial blood samples were collected at each visit.

Hypothesis: The pecan-enriched meal will blunt the post-meal increase in glucose, insulin, triglycerides (TG), and lipid peroxidation while improving all measures of subjective appetite and TAC compared to the traditional meal without nuts.

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Primary Purpose:

Other

Official Title:

Comparison of Metabolic and Antioxidant Responses to a Breakfast Meal With and Without Pecans

Actual Study Start Date :

Aug 10, 2017

Actual Primary Completion Date :

Feb 27, 2018

Actual Study Completion Date :

Feb 27, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control Participants in this group received a traditional muffin with butter as the predominant source of fat.	Other: Control Participants in this group received a traditional muffin with butter as the predominant source of fat.
Experimental: Pecan Participants in this group received a muffin in which part of the butter was substituted out for pecans.	Other: Pecan Participants in this group received a muffin in which part of the butter was substituted out for pecans.

Arm

Intervention/Treatment

Active Comparator: Control

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

Other: Control

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

Experimental: Pecan

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

Other: Pecan

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

Outcome Measures

Primary Outcome Measures

Change in triglycerides (TG) and glucose [Change from baseline to 3 hours postprandially]
TG (mg/dL) and glucose (mg/dL)
Change in lipid peroxidation [Change from baseline to 3 hours postprandially]
Malondialdehyde (MDA) (uM) measured via Thiobarbituric acid reactive substances (TBARS) assay
Change in total antioxidant capacity [Change from baseline to 3 hours postprandially]
Total antioxidant capacity (uM trolox equivalents) measured via Oxygen Radical Absorbance Capacity (ORAC) assay.
Change in insulin [Change from baseline to 3 hours postprandially]
Insulin (uU/mL)

Secondary Outcome Measures

Change in angiopoietin-like proteins-3 (ANGPTL3) and -4 (ANGPTL4) responses [Change from baseline to 3 hours postprandially]
ANGPTL3 (pg/mL) and ANGPTL4 (pg/mL)
Change in hunger and satiety responses [Change from baseline to 3 hours postprandially]
Hunger, fullness, prospective consumption, and desire to eat measured via a Visual Analog Scale (VAS) (mm). The range of scores on the continuous VAS is 0-100 mm. Zero represents no hunger, fullness, prospective consumption, and desire to eat, while 100 represents the greatest feeling of these outcomes.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Georgia - Department of Foods and Nutrition & Department of Food Science and Technology	Athens	Georgia	United States	30602

Sponsors and Collaborators

University of Georgia

Investigators

Principal Investigator: Chad M Paton, PhD, University of Georgia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jamie Cooper, PhD, Professor and Director of UGA Obesity Initiative, University of Georgia

ClinicalTrials.gov Identifier:

NCT04849962

Other Study ID Numbers:

AWD00008790

First Posted:

Apr 20, 2021

Last Update Posted:

Apr 20, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Apr 20, 2021