NCT02943434

Brief Summary

This study will examine differences in diet-induced thermogenesis (DIT) between a meal made of processed ingredients and an equivalent, isocaloric meal made of whole ingredients. For the purpose of this study processed foods (PFs) will be considered those that are purchased in a state that is modified from their whole food (WF) counterpart (e.g. shell eggs compared to powdered eggs). Research has shown that less energy is expended to digest processed foods than whole foods, which confers an advantage to processed foods in terms of caloric efficiency, but a disadvantage in terms of energy balance and weight loss. A 2010 study showed that subjects expended approximately 10% less energy to digest sandwiches made of white bread and cheese product compared to sandwiches made of whole grain bread and cheddar cheese. The intent of this study is to enhance those results and improve upon the study design by constructing meals to be more similar in the makeup of individual ingredients, making ingredient processing a more isolated variable. Subjects will be healthy CWU male students with a body mass index of 18.5 - 24.9 kg/m2. Metabolism will be assessed by repeated measurements of resting energy expenditure via indirect calorimetry. Measurements of baseline metabolism will be made; subjects will then be provided one of two meals, both comprised of rice, green beans, and eggs cooked in canola oil and equivalent but differing in processing status (e.g. brown rice and white rice, fresh cooked green beans and canned green beans, etc). Hourly metabolic measurements will be made post-meal for 6 hours. During this time subjects will be asked to minimize non-DIT deviations in metabolism; e.g. those due to physical activity, excitement level, etc. The procedure will be repeated one week later with the other meal so that changes in DIT can be assessed on a subject-by-subject basis. The results of this study will be assessed in the lens of weight loss, specifically dietary choices that affect energy balance. It is possible that consuming a diet that includes more whole foods (versus processed foods) would be beneficial to the attainment of a healthy body weight - either through potential weight loss or weight maintenance.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_1 obesity

Timeline
Completed

Started Jun 2016

Shorter than P25 for phase_1 obesity

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 24, 2016

Completed
Last Updated

October 24, 2016

Status Verified

October 1, 2016

Enrollment Period

1 month

First QC Date

October 20, 2016

Last Update Submit

October 21, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Changes in resting energy expenditure will be assessed via indirect calorimetry

    Resting energy expenditure will be assessed at baseline and post-baseline at hours 1, 2, 3, 4, 5, & 6 for a total of 7 measurements

Study Arms (2)

Processed Food

OTHER

Changes in resting energy expenditure will be measured via indirect calorimetry after consumption of a processed foods meal to determine changes in diet-induced thermogenesis.

Other: Processed food

Whole Food

OTHER

Changes in resting energy expenditure will be measured via indirect calorimetry after consumption of a whole foods meal to determine changes in diet-induced thermogenesis.

Other: Processed food

Interventions

This is examining the effects of processed foods on diet-induced thermogenesis.

Processed FoodWhole Food

Eligibility Criteria

Age18 Years - 25 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Males
  • Ages 18 - 25 years
  • BMI: 18.5 - 29.9 kg/m2

You may not qualify if:

  • Diagnosed with cardiovascular disease, cancer, diabetes, thyroid disorder, metabolic disorders, eating disorders, and/or egg allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Obesity

Interventions

Food, Processed

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Nicole R Stendell-Hollis, PhD

    Central Washington University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 20, 2016

First Posted

October 24, 2016

Study Start

June 1, 2016

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

October 24, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share