Clinical trial NCT02548026: Meals and Grazing Study
Official title: Meals and Grazing Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: meal frequency
eating frequency
ingestive frequency
positive energy balance
satiety
appetite
hunger
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
First posted: 2015-09-14
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study was to determine the effects of low vs. high eating frequency (EF) on biomarkers of health and subjective appetite.

Detailed description: Observational studies have demonstrated an inverse relationship between eating frequency (EF), obesity, and other markers for disease risk. It has been suggested that consumption of several small, frequent meals may influence physiological mechanisms, reducing the risk for disease and lowering appetite. Participants in this randomized crossover study completed two intervention phases lasting three weeks each: one of low eating frequency ("low-EF"; 3 eating occasions/day) and one of high eating frequency ("high-EF"; 8 eating occasions/day). Fasting C-reactive protein, insulin-like growth factor, and leptin were measured at baseline and endpoint of each phase and an optional subjective appetite testing session lasting four hours was offered at the endpoint of each phase. During appetite testing sessions, participants consumed an amount of food equal in total energy and macronutrient content at either one occasion at 8:00 am ("low-EF" condition) or spread evenly over two smaller eating occasions at 8:00 am and 10:30 am ("high-EF" condition). Ratings of hunger, desire to eat, fullness, thirst, and nausea were made every 30 minutes using paper-and-pencil semi-anchored 100-mm Visual Analog Scales. A composite appetite score was calculated as the mean of hunger, desire to eat, and 100-fullness. The generalized estimating equation modification of linear regression was used to compare fasting plasma biomarkers and mean ratings of subjective appetite.

Eligibility criteria: Inclusion Criteria:

* Participants will be overweight and obese (BMI 25 and over) males and females ages 18-50 years.
* Participants must be willing to report to FHCRC on 5 occasions (initial screening appointment + 4 testing sessions)
* Participants must be willing to provide a 7-day food record for analysis prior to Phase 1 and Phase 2 of the study
* Participants must be willing to follow diet protocol during Phase 1 of the study
* Participants must be willing to undergo 4 blood draws

Exclusion Criteria:

* Non-diabetic (self-report)
* Non-smokers (self-report)
* Not following a diet to gain or lose weight (self-report)
* Normal cholesterol (self-report)
* Normal blood pressure (self-report)
* Not currently taking any medication (self-report)
* Not pregnant or nursing (self-report and verification by DEXA)
* Not athletes in training (self-report)

Primary outcomes:
measure: Inflammatory biomarkers in high vs. low eating frequency conditions
timeFrame: 3 weeks
Secondary outcomes:
measure: Subjective appetite in high vs. low eating frequency conditions
timeFrame: 4 hours
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
Study officials:
affiliation: Fred Hutchinson Cancer Center
name: Marian Neuhouser, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Perrigue MM, Drewnowski A, Wang CY, Neuhouser ML. Higher Eating Frequency Does Not Decrease Appetite in Healthy Adults. J Nutr. 2016 Jan;146(1):59-64. doi: 10.3945/jn.115.216978. Epub 2015 Nov 11.