Meals and Grazing Study

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Behavioral: High Eating Frequency (High EF); Behavioral: Low Eating Frequency (Low EF)

• Registration Number: NCT02548026
• Lead Sponsor: Fred Hutchinson Cancer Center

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.

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2015-09
• Study First Submitted: 2015-09-08
• Study First Submitted QC: 2015-09-10
• Last Update Submitted: 2015-09-10
• Study First Posted: 2015-09-14
• Last Update Posted: 2015-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High Eating Frequency (High EF)	High Eating Frequency (High EF)	8 Eating Occasions
Low Eating Frequency (High EF)	Low Eating Frequency (Low EF)	3 Eating Occasions

Primary Outcome Measures

Name	Time	Method
Inflammatory biomarkers in high vs. low eating frequency conditions	3 weeks	Inflammatory biomarkers in high vs. low eating frequency conditions

Secondary Outcome Measures

Name	Time	Method
Subjective appetite in high vs. low eating frequency conditions	4 hours	Subjective appetite as reported using visual analog scale in high vs. low eating frequency conditions

Trial Locations

Locations (1)

Fred Hutchinson Cancer Research Center; 🇺🇸 Seattle, Washington, United States